DEA Psilocybin Lawsuit

Case: 21-70544, 06/25/2021, ID: 12155216, DktEntry: 45, Page 1 of 55
No. 21-70544
IN THE UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT
ADVANCED INTEGRATIVE MEDICAL SCIENCE INSTITUTE, PLLC, et al.,
Petitioners,
v.
MERRICK B. GARLAND, Attorney General, et al.,
Respondents.
On Petition for Review of a Non-Final Action of the Drug Enforcement

Administration
BRIEF FOR RESPONDENTS
BRIAN M. BOYNTON
Acting Assistant Attorney General
MARK B. STERN
THOMAS PULHAM
Attorneys, Appellate Staff
Civil Division, Room 7323
U.S. Department of Justice
950 Pennsylvania Avenue NW
Washington, DC 20530
(202) 514-4332
TABLE OF CONTENTS
Page
INTRODUCTION ..................................................................................................................1
STATEMENT OF JURISDICTION ...................................................................................3
STATEMENT OF THE ISSUES..........................................................................................3
PERTINENT STATUTES AND REGULATIONS ........................................................4
STATEMENT OF THE CASE .............................................................................................4
A. Statutory Background ........................................................................................ 4
1. The Controlled Substances Act ........................................................... 4
2. The Federal Food, Drug, and Cosmetic Act ..................................... 7
3. The Right to Try Act ...........................................................................10
B. Factual Background .........................................................................................13
SUMMARY OF ARGUMENT ........................................................................................... 16
STANDARD OF REVIEW ................................................................................................ 18
ARGUMENT ......................................................................................................................... 19
I. This Court Lacks Jurisdiction Over This Petition Because The DEA
Letter Is Not A Final Decision Subject To Review Under The CSA. ............... 19
II. The DEA Letter Is Consistent With Law And Reasonably Responded
To The Petitioners’ Request For Guidance............................................................ 23
A. DEA Correctly Described The Scope Of The Right To Try Act. ...........24
B. The DEA Letter Did Not Address Other Matters And Was Not
Arbitrary Or Capricious. .................................................................................33
CONCLUSION ..................................................................................................................... 36
STATEMENT OF RELATED CASES
CERTIFICATE OF COMPLIANCE
ADDENDUM
ii
TABLE OF AUTHORITIES
Cases: Page(s)
Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach,

495 F.3d 695 (D.C. Cir. 2007) ......................................................................... 8, 9, 10, 32
Alaska Dep’t of Envtl Conservation v. U.S. EPA,
244 F.3d 748 (9th Cir. 2001) ................................................................................... 20, 23
Alliance for Cannabis Therapeutics v. DEA,
15 F.3d 1131 (D.C. Cir. 1994) ........................................................................................ 35
Bennett v. Spear,
520 U.S. 154 (1997) ............................................................................................. 16, 20, 22
City of San Diego v. Whitman,
242 F.3d 1097 (9th Cir. 2001) ................................................................................. 17, 21
Epic Sys. Corp. v. Lewis,
138 S. Ct. 1612 (2018) ..................................................................................................... 32
FCC v. NextWave Pers. Commc’ns, Inc.,
537 U.S. 293 (2003) .......................................................................................................... 32
FDA v. Brown & Williamson Tobacco Corp.,
529 U.S. 120 (2000) ............................................................................................................ 7
Fry v. DEA,
353 F.3d 1041 (9th Cir. 2003) ........................................................................................ 19
Gallo Cattle Co. v. U.S. Dep’t of Agric.,
159 F.3d 1194 (9th Cir. 1998) ........................................................................................ 22
Gill v. U.S. Dep’t of Justice,
913 F.3d 1179 (9th Cir. 2019) ........................................................................................ 23
Golden & Zimmerman, LLC v. Domenech,
599 F.3d 426 (4th Cir. 2010) .......................................................................................... 22
Gonzales v. Oregon,
546 U.S. 243 (2006) ................................................................................................... 31, 34
Gonzales v. Raich,
545 U.S. 1 (2005) ...................................................................................... 2, 22, 28, 29, 30
iii
Hemp Indus. Ass’n v. DEA,

333 F.3d 1082 (9th Cir. 2003) ........................................................................... 16, 19, 23
Hemp Indus. Ass’n. v. DEA,
357 F.3d 1012 (9th Cir. 2004) ........................................................................................ 23
Holistic Candlers & Consumers Ass’n v. FDA,
664 F.3d 940 (D.C. Cir. 2012) ........................................................................................ 21
Independent Equip. Dealers Ass’n v. EPA,
372 F.3d 420 (D.C. Cir. 2004) ........................................................................... 21, 22, 23
John Doe, Inc. v. DEA,
484 F.3d 561 (D.C. Cir. 2007) ........................................................................... 19, 20, 21
Mathew v. U.S. DEA,
472 F. App’x 453 (9th Cir. 2012) ................................................................................... 23
Morton v. Mancari,
417 U.S. 535 (1974) .......................................................................................................... 32
Oregon v. Ashcroft,
368 F.3d 1118 (9th Cir. 2004) ................................................................................. 19, 23
Posadas v. National City Bank,

296 U.S. 497, 503 (1936) .................................................................................................... 32
Sackett v. EPA,
566 U.S. 120 (2012) .......................................................................................................... 23
San Francisco Herring Ass’n v. Department of the Interior,
946 F.3d 564 (9th Cir. 2019) .......................................................................................... 22
Tourus Records, Inc. v. DEA,
259 F.3d 731 (D.C. Cir. 2001) ........................................................................................ 19
United States v. Canori,
737 F.3d 181 (2d Cir. 2013) ............................................................................................ 30
United States v. Evers,
643 F.2d 1043 (5th Cir. 1981) ........................................................................................ 30
United States v. Moore,
423 U.S. 122 (1975) ..................................................................................................... 5, 27
iv
United States v. 9/1 Kg. Containers,

854 F.2d 173 (7th Cir. 1988) .......................................................................................... 30
United States v. Oakland Cannabis Buyers’ Coop.,
532 U.S. 483 (2001) ............................................................................................... 6, 31, 32
United States v. Regenerative Scis., LLC,
741 F.3d 1314 (D.C. Cir. 2014) ...................................................................................... 30
Valero Energy Corp. v. EPA,
927 F.3d 532 (D.C. Cir. 2019) .................................................................... 17, 21, 22, 23
Wedgewood Vill. Pharmacy v. DEA,
509 F.3d 541 (D.C. Cir. 2007) ................................................................................... 5, 28
Whitman v. American Trucking Ass’ns.,
531 U.S. 457 (2001) ................................................................................................... 18, 29
Treaty:
United Nations Convention on Narcotic Drugs: Psychotropic Substances,
Feb. 21, 1971, 32 U.S.T. 543, 1019 U.N.T.S. 175 ............................................................ 7
Art. 7(a) .............................................................................................................................. 7
Art. 7(f) ............................................................................................................................... 7
Art. 12 ................................................................................................................................. 7
Appended List of Substances in the Schedules ........................................................... 7
Statutes:
Agricultural Improvement Act of 2018,

Pub. L. No. 115-334, 132 Stat. 4490 ................................................................................ 26
§ 12619 ............................................................................................................................. 35
Controlled Substances Act (CSA),

21 U.S.C. § 801 et seq. ............................................................................................................ 4
21 U.S.C. §§ 801-904 ...................................................................................................... 5
21 U.S.C. § 801a(1) ......................................................................................................... 7
21 U.S.C. § 801a(2) ......................................................................................................... 7
21 U.S.C. § 802 ................................................................................................................ 5
21 U.S.C. § 802(10) ......................................................................................................... 5
21 U.S.C. § 802(21) ......................................................................................................... 5
21 U.S.C. § 811 ................................................................................................................ 6
21 U.S.C. § 812 ................................................................................................................ 6
v
21 U.S.C. § 812(b) .................................................................................................... 5, 13

21 U.S.C. § 812(b)(1) ............................................................................................... 6, 31
21 U.S.C. § 812(c) ............................................................................................. 1, 3, 6, 31
Sched. I(c)(15) ........................................................................................................ 6, 13
21 U.S.C. § 822(a)(2) ...................................................................................................... 5
21 U.S.C. § 822(b) ........................................................................................................... 5
21 U.S.C. § 822(d) ........................................................................................................... 3
21 U.S.C. § 823(f) .......................................................................................... 2, 6, 25, 31
21 U.S.C. § 841(a)(1) ................................................................................................. 2, 5
21 U.S.C. § 844(a) ...................................................................................................... 2, 5
21 U.S.C. § 877 .................................................................................... 2, 3, 4, 16, 18, 19
21 U.S.C. § 902 .............................................................................................................. 24
21 U.S.C. § 903 ................................................................................................................ 7
Federal Food, Drug, and Cosmetic Act (FDCA):
21 U.S.C. § 331 .................................................................................................................... 7
21 U.S.C. § 355(a) ............................................................................................................... 8
21 U.S.C. § 355(b) ............................................................................................................... 8
21 U.S.C. § 355(d) ............................................................................................................... 8
21 U.S.C. § 355(i) ..................................................................................................... 6, 8, 25
21 U.S.C. § 360bbb ............................................................................................................. 10
21 U.S.C. § 360bbb-0a(a)(1) ............................................................................................ 11
21 U.S.C. § 360bbb-0a(a)(2) ..................................................................................... 11, 24
21 U.S.C. § 360bbb-0a(b) .......................................................................................... 11, 24
21 U.S.C. § 360bbb-0a(d) ................................................................................................. 12
21 U.S.C. 377(a) ................................................................................................................. 27
Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina

Right to Try Act of 2017, Pub. L. No. 115-176, 132 Stat. 1372 (2018)........................ 1
§ 1 ........................................................................................................................................ 1
§ 2(b) .......................................................................................................................... 18, 26
§ 2(b)(1) ............................................................................................................................ 12
§ 2(b)(1)(B)....................................................................................................................... 26
§ 2(b)(2) ............................................................................................................................ 12
§ 2(b)(3) ..................................................................................................................... 12, 27
§ 3(1) .......................................................................................................................... 12, 26
§ 3(3) ................................................................................................................................. 13
§ 3(4) .......................................................................................................................... 13, 27
5 U.S.C. § 704 ......................................................................................................................... 20
vi
5 U.S.C. § 706(2)(A) .............................................................................................................. 19

Pub. L. No. 105-277, div. F, 112 Stat. 2681-760 to -761 ............................................. 6, 31
Regulations:
21 C.F.R. pt. 312 ............................................................................................................... 8, 25

21 C.F.R. § 312.7 ............................................................................................................... 11
21 C.F.R. § 312.21 ............................................................................................................... 8
21 C.F.R. § 312.21(a)(1) ..................................................................................................... 8
21 C.F.R. § 312.21(b) .......................................................................................................... 8
21 C.F.R. § 312.21(c) .......................................................................................................... 9
21 C.F.R. § 312.32 ............................................................................................................... 9
21 C.F.R. § 312.40(b)(1) ..................................................................................................... 9
21 C.F.R. § 312.42(b) .......................................................................................................... 9
21 C.F.R. § 312.81(a) ........................................................................................................ 11
Subpt. I ................................................................................................................................. 10
21 C.F.R. §§ 312.300-.305 ........................................................................................... 10
21 C.F.R. § 1307.03 ............................................................................................................... 34

21 C.F.R. § 1316.24 ........................................................................................................ 15, 20
28 C.F.R. § 0.100 ................................................................................................................... 19
Other Authorities:
AIMS Inst., Integrative Oncology, https://www.aimsinstitute.net/services/

integrative-oncology/ (last visited June 24, 2021) ..........................................................13
Black’s Law Dictionary (11th ed. 2019) ...................................................................................27
DEA, Psilocybin, https://go.usa.gov/x6yRW (last visited June 24, 2021) .................. 1, 13
FDA:
Expanded Access, https://go.usa.gov/x6VPW (last updated Mar. 23, 2021) ..............10
Expanded Access Program Report 5, 14 (May 2018) ............................................................10
FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol
(CBD) (Jan. 22, 2021), https://go.usa.gov/x6VMN .................................................26
Right to Try, https://go.usa.gov/x6y5r (last updated Jan. 14, 2020) ............................12
57 Fed. Reg. 10,499 (Mar. 26, 1992) ................................................................................... 35
vii
66 Fed. Reg. 56,607 (Nov. 9, 2001) ...................................................................................... 31

85 Fed. Reg. 44,803 (July 24, 2020) .................................................................................... 12
Peter D. Jacobson & Wendy E. Parmet, A New Era of Unapproved Drugs:

The Case of Abigail Alliance v. von Eschenbach, 297 JAMA 205 (2007) ............................... 9
viii
INTRODUCTION
The federal Right to Try Act,1 Pub. L. No. 115-176, 132 Stat. 1372 (2018),
clears a new path for patients diagnosed with life-threatening conditions to gain access
to certain drugs that have not yet been approved as safe and effective by the Food
and Drug Administration (FDA). The law does not provide a right to use any specific
treatment. Rather, it permits the distribution of eligible drugs by providing limited
exemptions to specified provisions of the Federal Food, Drug, and Cosmetic Act that
regulate the labeling, approval, and clinical trials of drugs. The Right to Try Act does
not exempt anyone from complying with the Controlled Substances Act, or even
mention controlled substances at all.
The petitioners in this case are a medical institute, a doctor, and two patients
suffering from cancer who wish to use psilocybin to treat their depression and anxiety.
Psilocybin is a hallucinogenic substance found in certain mushrooms. See Drug Enf’t
Admin., Psilocybin, https://go.usa.gov/x6yRW (last visited June 24, 2021). When
Congress passed the Controlled Substances Act, it placed psilocybin in the most
strictly controlled category of drugs based on a conclusion that psilocybin had a high
potential for abuse and no accepted medical use in treatment. 21 U.S.C. § 812(c). It
is unlawful to manufacture, distribute, or possess any drugs in this category, except as
1
The full name of the Act is the “Trickett Wendler, Frank Mongiello, Jordan
McLinn, and Matthew Bellina Right to Try Act of 2017.” See Pub. L. No. 115-176,
§ 1, 132 Stat. at 1372.
part of a preapproved research study. Gonzales v. Raich, 545 U.S. 1, 14 (2005) (citing
21 U.S.C. §§ 823(f ), 841(a)(1), 844(a)). This is so regardless of whether a state law
would authorize use of the drug or whether a person claims a legitimate medical need.
Id. at 29.
The petitioners nevertheless wrote to the Drug Enforcement Administration
(DEA) seeking guidance on how they might obtain psilocybin under the Right to Try
Act. The agency explained that the new statute did not waive the requirements of the
Controlled Substance Act or provide the agency with authority to do so. But the
agency suggested that the petitioners might consider applying for access under the
research exception described above. Dissatisfied with this response, the petitioners
have sought judicial review of the agency’s advice.
This Court lacks jurisdiction over the petition for review. The Controlled
Substances Act limits judicial review to DEA’s “final” decisions. 21 U.S.C. § 877.
Here, DEA did not make any kind of final decision. It did not create a new rule or
grant or deny an application. DEA merely shared its view of the Right to Try Act as a
courtesy to members of the regulated community. But even if DEA’s letter were
reviewable, the petitioners’ suit would still fail. The Right to Try Act does not silently
limit the federal government’s ability to regulate the distribution and use of controlled
substances. Nor did DEA categorically and permanently deny the petitioners access
to psilocybin under any circumstances or under any conceivable agency authority.
Rather, the agency responded to their limited request for guidance by correctly
2
describing the scope of the exemptions created in the Right to Try Act. This was
neither contrary to law nor arbitrary and capricious.
STATEMENT OF JURISDICTION
The petitioners seek review of a letter issued by DEA on February 12, 2021.
SER-3. The Controlled Substances Act provides that “any person aggrieved by a final
decision” made by DEA “may obtain review of the decision in the United States
Court of Appeals . . . for the circuit in which his principal place of business is located
upon petition filed with the court and delivered to the Attorney General within thirty
days after notice of the decision.” 21 U.S.C. § 877. Petitioners timely filed their
petition for review on March 8, 2021. Nevertheless, this Court lacks jurisdiction
because, as explained below, the petitioners do not seek review of any final action by
DEA.
STATEMENT OF THE ISSUES
The Right to Try Act amended the Federal Food, Drug, and Cosmetic Act to
authorize the distribution of certain unapproved drugs for use by patients with life-
threatening conditions. The petitioners wish to use psilocybin—a hallucinogenic
substance found in certain mushrooms—for the treatment of depression and anxiety
in cancer patients. Congress placed psilocybin on Schedule I of the Controlled
Substances Act based on a conclusion that the drug had no accepted medical use in
treatment. 21 U.S.C. § 812(c). The petitioners sought guidance from DEA as to how
they could obtain psilocybin under the Right to Try Act for therapeutic use.
3
Responding to that request, DEA stated that the Right to Try Act does not permit the
agency to waive any requirements of the Controlled Substances Act, and it identified
another possible option for the doctor to consider. The questions presented are:
1. Whether DEA’s response letter is a final agency action subject to judicial
review under 21 U.S.C. § 877.
2. Whether, assuming that judicial review is available, the letter was arbitrary
and capricious or contrary to law.
PERTINENT STATUTES AND REGULATIONS
Pertinent statutes and regulations are reproduced in the addendum to this brief.
STATEMENT OF THE CASE
A. Statutory Background
This case concerns the intersection of three federal laws regulating the
distribution and use of drugs in the United States: the Controlled Substances Act; the
Federal Food, Drug, and Cosmetic Act; and the Right to Try Act.
1. The Controlled Substances Act
The Controlled Substances Act (CSA), 21 U.S.C. § 801 et seq., establishes a
comprehensive federal scheme for the regulation of dangerous drugs and similar
substances. The law makes it unlawful to “manufacture, distribute, or dispense, or
possess with intent to manufacture, distribute, or dispense” any controlled substance,
4
“[e]xcept as authorized by [21 U.S.C. §§ 801-904].” 21 U.S.C. § 841(a)(1).2 It is
similarly a crime to possess any controlled substance except as expressly authorized.
Id. § 844(a). The CSA thus establishes a “closed system of distribution,” Wedgewood
Vill. Pharmacy v. DEA, 509 F.3d 541, 542 (D.C. Cir. 2007) (quotation marks omitted),
authorizing certain transactions “within the legitimate distribution chain and mak[ing]
all others illegal.” United States v. Moore, 423 U.S. 122, 141 (1975) (quotation marks
omitted).
To dispense controlled substances lawfully, a physician or other practitioner
must “obtain from the Attorney General a registration.” 21 U.S.C. § 822(a)(2).
Registered physicians or other practitioners may dispense controlled substances only
“in the course of professional practice or research,” id. § 802(21), and only “to the
extent authorized by their registration and in conformity with the other provisions of
[the CSA],” id. § 822(b).
The CSA classifies controlled substances into five separate schedules based on
their safety, the extent to which they have an accepted medical use, and the potential
for abuse. 21 U.S.C. § 812(b). The Act imposes varying regulatory restrictions on
controlled substances depending on the applicable schedule. Substances in Schedule
2
Under the CSA, the term “dispense” includes the issuance of a prescription
by a practitioner as well as delivering a controlled substance directly to a patient.
21 U.S.C. § 802(10). A “controlled substance” is “a drug,” as defined under the
Federal Food, Drug, and Cosmetic Act, “or other substance, or immediate precursor”
listed on one of five schedules. Id. § 802.
5
I—the most restricted schedule—have “a high potential for abuse,” “no currently
accepted medical use in treatment in the United States,” and “a lack of accepted safety
for use . . . under medical supervision.” Id. § 812(b)(1). The CSA prohibits human
consumption of Schedule I controlled substances except in a research setting where
the research has been allowed to proceed by FDA and the researcher has obtained
from DEA a registration authorizing the specific research protocol. Id. §§ 355(i),
823(f ); see United States v. Oakland Cannabis Buyers’ Coop., 532 U.S. 483, 491 (2001).
When the CSA was enacted in 1970, Congress made an initial assignment of
controlled substances to the schedules it found appropriate. 21 U.S.C. § 812(c).
Congress placed psilocybin in Schedule I. Id. sched. I(c)(15).3 The CSA authorizes
the Attorney General, in consultation with the Secretary of Health and Human
Services, to add or remove substances or to transfer substances from one schedule to
another based upon statutory criteria that take into account changes in medical and
scientific understanding and shifts in patterns of abuse. Id. §§ 811, 812. States remain
free to enact their own laws relating to controlled substances, such as their own
criminal penalties, but state laws are preempted to the extent of any “positive
3
In 1998, Congress passed a resolution reaffirming that the drugs “listed on
Schedule I of the Controlled Substances Act . . . have a high potential for abuse, lack
any currently accepted medical use in treatment, and are unsafe, even under medical
supervision.” Pub. L. No. 105-277, div. F, 112 Stat. 2681, 2681-760. Congress also
expressed its “continue[d]” “support [for] the existing Federal legal process for
determining the safety and efficacy of drugs and oppose[d] efforts to circumvent this
process” and to establish legal uses for Schedule I drugs “without valid scientific
evidence.” Id.; 112 Stat. at 2681-761.
6
conflict” between a provision of state law and the CSA such that the two “cannot
consistently stand together.” Id. § 903.
The CSA implements the United States’ obligations under the United Nations
Convention on Narcotic Drugs: Psychotropic Substances, Feb. 21, 1971, 32 U.S.T.
543, 1019 U.N.T.S. 175, https://www.unodc.org/pdf/convention 1971 en.pdf
(Convention). See 21 U.S.C. § 801a(2). Congress recognized that it was “essential that
the United States cooperate with other nations in establishing effective controls over
international traffic” in psychotropic substances such as psilocybin. Id. § 801a(1).
Like the CSA, the Convention divides covered substances into schedules, and it lists
psilocybin as a Schedule I substance subject to the most rigorous controls. See
Convention, Appended List of Substances in the Schedules. The Convention
obligates the United States to “prohibit all use” of psilocybin and preparations
containing it, “except for scientific and very limited medical purposes . . . directly
under the control” of or approved by the government. Id. arts. 7(a), (f ), 12.
2. The Federal Food, Drug, and Cosmetic Act
The Federal Food, Drug, and Cosmetic Act (FDCA) imposes substantive
restrictions on the distribution of all drugs—not only those designated as controlled
substances. See 21 U.S.C. § 331. One of the FDCA’s “core objectives” is to ensure
that any drug used in the United States is “safe and effective for its intended use.”
FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 133, 134 (2000). To that end,
the statute generally prohibits the introduction into interstate commerce of new drugs
7
unless and until they have been approved by FDA. 21 U.S.C. § 355(a); see also Abigail
Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695, 697 (D.C.
Cir. 2007).
To approve a new drug, FDA must determine that the drug is “safe and
effective” for each of is intended uses, based on “substantial evidence” gathered from
“well-controlled investigations” conducted by scientific experts. 21 U.S.C. § 355(a),
(b), (d). Clinical testing on humans is a prerequisite for the approval of a new drug
application. But before such testing can even begin, the drug’s sponsor must submit
an investigational new drug application describing the protocols for planned studies
and establishing that human testing is appropriate. See generally 21 U.S.C. § 355(i);
21 C.F.R. pt. 312.
FDA regulations prescribe a three-phase process for the clinical testing of a
new drug for safety and effectiveness. 21 C.F.R. § 312.21. Phase 1 involves the initial
introduction of the new drug into a small number of human subjects (typically twenty
to eighty) and is “designed to determine the metabolism and pharmacologic actions of
the [new] drug in humans, the side effects associated with increasing doses, and, if
possible, to gain early evidence on effectiveness.” Id. § 312.21(a)(1). Phase 2 involves
a well-controlled, closely monitored study of the drug in a small group of patients
(usually no more than several hundred) to evaluate “the effectiveness of the drug for a
particular indication” and “to determine [its] common short-term side effects and
risks.” Id. § 312.21(b). Phase 3 involves large clinical trials (of several hundred to
8
several thousand subjects) designed to gather “additional information about
effectiveness and safety that is needed to evaluate the overall benefit-risk relationship
of the drug and to provide an adequate basis for physician labeling.” Id. § 312.21(c).
Throughout the course of the clinical trials, the sponsor is required to notify
FDA of any “serious and unexpected” adverse drug experiences. 21 C.F.R. § 312.32.
If FDA is concerned about the safety of an investigational drug, it may suspend a trial
by issuing a “clinical hold,” and if the safety concerns are sufficiently great, FDA may
order the termination of the trial. Id. §§ 312.40(b)(1), 312.42(b).
That a clinical trial is allowed to proceed from Phase 1 to subsequent phases
does not represent a judgment by FDA that the investigational drug is either safe or
effective for use in treating diseases. Preliminary expectations of safety and efficacy
often prove to be unfounded, and drugs that initially appear to be promising are
frequently revealed to be ineffective or even affirmatively harmful. Successful clinical
trials are the exception, not the rule, as “the great majority of experimental drugs
ultimately provide no benefit.” Abigail Alliance, 495 F.3d at 708 n.15. For example,
only five percent of all cancer drugs that begin clinical testing are ultimately approved
for patient use, and even among cancer drugs that successfully complete Phase 1
testing, less than a third proceed from Phase 2 to Phase 3. Id. (citing Peter D.
Jacobson & Wendy E. Parmet, A New Era of Unapproved Drugs: The Case of Abigail
Alliance v. von Eschenbach, 297 JAMA 205, 206 (2007)).
9
In some circumstances, when other treatments are unavailing, patients may
seek access to investigational drugs outside of the clinical trial process using the FDA
“expanded access” program. See 21 U.S.C. § 360bbb; 21 C.F.R. pt. 312, subpt. I; see
also Abigail Alliance, 495 F.3d at 698-99. These expanded access procedures may
permit a patient with an “immediately life-threatening” or “serious” disease or
condition to gain access to an investigational product outside of a clinical trial when
no comparable or satisfactory alternative therapy options are available. 21 C.F.R.
§§ 312.300-.305; see generally FDA, Expanded Access, https://go.usa.gov/x6VPW (last
updated Mar. 23, 2021). FDA receives approximately 1,800 requests each year for
expanded access to investigational products, and it authorizes 99% of those requests.
FDA, Expanded Access Program Report 5, 14 (May 2018), https://www.fda.gov/media/
119971/download Despite this high volume, emergency requests for single patients
are typically reviewed in less than one day, and non-emergency requests for single
patients seeking access to investigational drugs are typically resolved in approximately
eight days. Id. at 14-15. FDA’s role in reviewing expanded access requests permits
the agency to ensure that patient safety is protected, including by requiring changes to
the treatment protocol or strengthening informed consent where necessary.
3. The Right to Try Act
In 2018, Congress enacted the Right to Try Act, which amends the FDCA to
provide a new pathway by which certain patients might be able to access certain
unapproved medical products. The Right to Try Act provides that that “[e]ligible
10
investigational drugs provided to eligible patients in compliance with this section are
exempt from” specified statutory and regulatory provisions governing the labeling,
approval, and clinical trials of drugs. 21 U.S.C. § 360bbb-0a(b). Such exemptions are
contingent, however, on compliance with regulations that forbid promoting,
commercially distributing, or test marketing investigational drugs. Id. (requiring
compliance with 21 C.F.R. 312.7).
An “eligible investigational drug” is a drug that (1) is not approved or licensed
by FDA for any use, (2) has been the subject of a phase 1 clinical trial, (3) is the
subject of a new drug application filed with FDA (meaning clinical trials have been
completed) or is the subject of an active investigational new drug application and is
currently under investigation in a clinical trial, and (4) is under active development or
production and was not discontinued by the manufacturer or placed on a clinical hold
by FDA. 21 U.S.C. § 360bbb-0a(a)(2). An “eligible patient” is someone who has
been diagnosed with a “life-threatening disease or condition,”4 has “exhausted
approved treatment options and is unable to participate in a clinical trial involving the
eligible investigational drug” (as certified by a physician), and has provided written
informed consent regarding the drug in question. Id. § 360bbb-0a(a)(1).
4
A “life-threatening disease or condition” includes diseases and conditions
where “the likelihood of death is high unless the course of the disease is interrupted”
and those “with potentially fatal outcomes, where the end point of clinical trial
analysis is survival.” 21 C.F.R. § 312.81(a). Examples include cancer, heart attack,
chronic or active hepatitis, and trauma.
11
FDA does not review or approve requests for the use of investigational drugs
under the Right to Try Act. Rather, the agency’s role primarily involves the receipt
and posting of certain information that the manufacturers or sponsors of the drugs
must submit. See 21 U.S.C. § 360bbb-0a(d); see also 85 Fed. Reg. 44,803 (July 24, 2020)
(proposing regulations regarding the deadline and contents of required submissions).
FDA advises that “the sponsor of the investigational drug . . . is in the best position to
provide information about whether the drug . . . meets the criteria to be considered an
eligible investigational drug.” FDA, Right to Try, https://go.usa.gov/x6y5r (last
updated Jan. 14, 2020).
An uncodified portion of the Right to Try Act limits liability of parties with
respect to the provision of investigational drugs under the Act. It provides that “no
liability in a cause of action shall lie against” a sponsor or manufacturer of an eligible
drug, or against an individual (such as a person who prescribes or dispenses the drug),
unless that individual commits reckless or willful misconduct, gross negligence, or an
intentional tort under state law. Pub. L. No. 115-176, § 2(b)(1), 132 Stat. at 1374.
The Right to Try Act also provides that “[n]o liability shall lie against” any party for
“its determination not to provide access to an eligible investigational drug” to a
patient. Id. § 2(b)(2). In all other respects, the ability to bring a private action is
preserved. Id. § 2(b)(3).
The Right to Try Act states that it was not intended to “establish a new
entitlement” or a “positive right” in any individual. Pub. L. No. 115-176, § 3(1), 132
12
Stat. at 1374. Rather, the law “only expands the scope of individual liberty and agency
among patients, in limited circumstances.” Id. § 3(3). It was understood that this new
access to investigational drugs would be “consistent with, and . . act as an alternative
pathway alongside, existing expanded access policies.” Id. § 3(4).
B. Factual Background
The Advanced Integrative Medical Science Institute “is an integrative oncology
clinic located in Seattle.” ER-4. Integrative oncology involves the use of “natural and
supportive therapies to reduce side effects, to help optimize conventional care and
prevent recurrence” of cancer. AIMS Inst., Integrative Oncology,
https://www.aimsinstitute.net/services/integrative-oncology/ (last visited June 24,
2021). Dr. Sunil Aggarwal is a co-director of the Institute and “a palliative care
specialist who treats patients with advanced cancer.” ER-4.
In December of 2020, the Institute and Aggarwal approached Organix, Inc., a
research and development contractor, seeking to obtain psilocybin for use with
seriously ill cancer patients. SER-14. Psilocybin is a hallucinogenic drug obtained
from certain kinds of mushrooms. DEA, Psilocybin, https://go.usa.gov/x6yRW.
While it has no currently accepted medical use in treatment, see 21 U.S.C. § 812(b),
Schedule I(c)(15), psilocybin has been studied as an investigational drug for the
possible treatment of anxiety and depression. ER-26. The petitioners explained that
they had been unable to obtain psilocybin from the Usona Institute, the drug’s
sponsor under an investigational new drug application, and therefore inquired if

13
Organix would be able to provide it. SER-14, ER-15. A representative explained that
Organix “operates under DEA regulations” and could “only ship a DEA Schedule I
compound such as psilocybin upon receipt of a copy of the requesting organization’s
current DEA Schedule I license” and proper paperwork. SER-11.
The Institute and Agarwal next approached DEA to “seek [its] guidance on
how DEA will accommodate [the Right to Try Act] so that Dr. Aggarwal and the
AIMS Institute can obtain psilocybin for therapeutic use with terminally ill patients.”
ER-4. In a letter dated January 15, 2021, the petitioners represented that the Institute
“intends to purchase psilocybin from Organix, a company which holds an
[investigational new drug application] for this drug and is registered as a Distributor of
this drug.” ER-6; but see ER-15, ER-22 (informed consent forms for Aggarwal’s
patients identifying Usona as the holder of the investigational new drug application
for the psilocybin that would be administered). The petitioners explained that they
were interested in obtaining the substance “pursuant to the Washington and U.S.
Right to Try (RTT) Acts” and conveyed their view that the statutes permit such access
because they do not “exclude Schedule I substances from their scope.” ER-4, ER-6.
They observed that the “existing DEA forms do not appear to accommodate” such
access and asked whether Aggarwal should “seek registration as a ‘researcher.’ ” ER-6.
The petitioners closed their letter expressing their “hope [that] DEA can promptly
advise on how to proceed.” Id.
14
Before DEA had responded, the petitioners followed their letter with an email
identifying another possible route to obtaining psilocybin. They suggested that the
agency could “issue an exemption from prosecution from the CSA,” pointing to a
regulation that permits such exemptions for individuals who register to engage in
research in controlled substances. SER-5 (citing 21 C.F.R. § 1316.24). The
petitioners asked for “DEA’s guidance on whether it would be preferable to proceed
with a Petition for Exemption.” Id.
DEA responded by letter signed on February 12, 2021. SER-3. The agency
described its understanding of the petitioners’ request: they wished to obtain
psilocybin “pursuant to the ‘Right to Try Act’ (RTT)” and they “ask[ed] DEA for
guidance on how DEA will accommodate” their request under that statute. Quoting
the statute’s operative language, DEA explained that the Right to Try Act “does not
waive the requirements of any provision of the Controlled Substances Act (CSA) or
its implementing regulations.” Accordingly, the agency related its view that it “has no
authority to waive any of the CSA’s requirements pursuant to the RTT.” Id.
DEA then addressed the applicability of the specific administrative pathways
mentioned in the petitioners’ correspondence. The agency confirmed that “[a]
potential avenue for Dr. Aggarwal to pursue is to apply for a Schedule I researcher
registration with DEA to conduct research with psilocybin,” and explained where to
find information about such applications. SER-4. With respect to the exemption
from prosecution, however, DEA explained that the regulation cited by the
15
petitioners “only applies to individuals already registered with DEA to engage in
research in controlled substances” and “would therefore not be applicable to Dr.
Aggarwal at this time.” But DEA noted that Aggarwal could “petition the DEA
Administrator for a grant of exemption from prosecution” after he obtained a
researcher registration. Id.
The AIMS Institute and Aggarwal, joined by two patients who wish to take
psilocybin to alleviate their depression and anxiety, ER-12, ER-20, seek judicial review
of DEA’s letter.
SUMMARY OF ARGUMENT
The Right to Try Act creates a pathway by which eligible patients with life-
threatening conditions can obtain drugs not yet approved by FDA. Petitioners wrote
to DEA seeking “guidance” as to how they could obtain psilocybin “pursuant to the
Washington and U.S. Right to Try (RTT) Acts.” ER-4. Congress has placed
psilocybin on Schedule I of the CSA, and subject to certain exceptions provided in the
CSA itself, it may not be distributed, dispensed or possessed legally. DEA explained
that the Right to Try Act “does not waive the requirements of any provision of the
Controlled Substances Act (CSA) or its implementing regulations.” SER-3.
1. The Court lacks jurisdiction over this petition for review because it does not
challenge a “final decision” reviewable under the CSA. 21 U.S.C. § 877; see Hemp
Indus. Ass’n v. DEA, 333 F.3d 1082, 1085 (9th Cir. 2003). The letter does not mark
the consummation of a decisionmaking process, Bennett v. Spear, 520 U.S. 154, 177-78
16
(1997); it responds to a request for guidance on how to request a decision. Nor does
the letter determine any rights or obligations or give rise to any legal consequences.
Id. at 178. The guidance letter did not compel the petitioners to do or to refrain from
doing anything. Any legal consequences they would face from dispensing or using
psilocybin imposed by the CSA and are not affected by DEA’s letter noting its view
of another statute. “[A]n agency works no legal effect merely by expressing its view
of the law.” Valero Energy Corp. v. EPA, 927 F.3d 532, 536 (D.C. Cir. 2019) (quotation
marks omitted); see also City of San Diego v. Whitman, 242 F.3d 1097, 1102 (9th Cir.
2001). Permitting judicial review of such documents would only discourage agencies
from responding to requests for assistance from members of the regulated
community.
2. Assuming that the Court has jurisdiction to review the DEA letter, the
petitioners fundamentally misunderstand the interaction of the Right to Try Act, the
CSA, and the FDCA. DEA correctly explained that the Right to Try Act “does not
waive the requirements of any provision” of the CSA and does not provide the agency
with “authority to waive” any of those requirements. SER-3. Indeed, the Right to Try
Act makes no reference to the CSA or to controlled substances.
The petitioners urge that psilocybin must be legally available, despite its
placement on Schedule I, because the CSA contains a longstanding savings clause
stating that its provisions should not be construed to supersede the provisions of the
FDCA. But this provision does not call into question any restrictions on Schedule I
17
drugs. The CSA and the FDCA are separate regulatory schemes with separate
protocols and restrictions. Uses of a drug for certain purposes may be permitted by
one statute but precluded by the other. Petitioners also rely on a provision in the
Right to Try Act that limits the “liability in a cause of action” against parties who
comply with the Act. Pub. L. No. 115-176, § 2(b), 132 Stat. at 1374. But this
provision is directed at civil litigation by private parties. Had Congress intended to
limit federal enforcement of the nation’s drug laws, it would have said so explicitly.
See Whitman v. American Trucking Ass’ns, 531 U.S. 457, 468 (2001) (“[Congress] does
not, one might say, hide elephants in mouseholes.”).
The Petitioners are on no firmer ground in criticizing DEA for addressing the
effect of the Right to Try Act and not addressing statutory provisions that the
petitioners now suggest might allow them to possess psilocybin legally. They urge this
Court not only to review informal views set out in a letter responding to a request for
guidance regarding the Right to Try Act, but to go further and pass, in the first
instance, on the scope of legal authorities that were not the subject of that request for
guidance. There is no basis for doing so.
STANDARD OF REVIEW
Judicial review of final decisions made under the CSA is governed by 21 U.S.C.
§ 877. The agency’s findings of fact are conclusive if supported by substantial
evidence. Id. Because § 877 does not specify a standard of review for the agency’s
legal reasoning and exercise of discretion, “[t]he narrow parameters of [this Court’s]
18
review are set by the Administrative Procedure Act [(APA)].” Fry v . DEA, 353 F.3d
1041, 1043 (9th Cir. 2003); see also Tourus Records, Inc. v. DEA, 259 F.3d 731, 736 (D.C.
Cir. 2001). Thus, this Court “may not substitute its judgment for the agency’s” and
may only set aside DEA’s action if it was “arbitrary, capricious, an abuse of discretion
or not in accordance with the law.” Fry, 353 F.3d at 1043 (citing 5 U.S.C.
§ 706(2)(A)).
ARGUMENT
I. This Court Lacks Jurisdiction Over This Petition Because The

DEA Letter Is Not A Final Decision Subject To Review Under
The CSA.
Under 21 U.S.C. § 877, this Court has “original jurisdiction over ‘final
determinations, findings, and conclusions of the Attorney General’ made under the
CSA.” Oregon v. Ashcroft, 368 F.3d 1118, 1120 (9th Cir. 2004) (quoting § 877); see also
28 C.F.R. § 0.100 (delegating the Attorney General’s authority to DEA). Thus, this
Court has recognized that its jurisdiction under § 877 “depends on whether th[ere] is a
final determination.” Hemp Indus. Ass’n v. DEA, 333 F.3d 1082, 1085 (9th Cir. 2003);
see also John Doe, Inc. v. DEA, 484 F.3d 561, 565 (D.C. Cir. 2007) (explaining that
finality is jurisdictional where “review is sought under a specific statute prescribing
finality as a prerequisite of judicial review”).
Agency action is final when two conditions are satisfied: first, the action must
“mark the consummation of the agency’s decisionmaking process,” and second, it
must be an action “by which rights or obligations have been determined, or from
19
which legal consequences will flow.” Bennett v. Spear, 520 U.S. 154, 177-78 (1997)
(quotation marks omitted).5 Here, neither condition is satisfied.
First, the letter at issue here does not mark the consummation of a
decisionmaking process. The petitioners asked the agency for guidance as to how
they might achieve their objective of obtaining psilocybin, and the agency responded
by explaining which of the proposed routes were viable in its view. DEA noted that
access pursuant to the Right to Try Act and an exemption from prosecution were not
available, but a researcher registration might be a “potential avenue” to access. SER-
4. This letter did not begin a decisionmaking process, let alone consummate one.
Indeed, the petitioners did not ask DEA to make a decision—they asked the
agency “how to proceed” with requesting one. ER-6. This is clear not only in their
opening letter asking about researcher registration, but also in the follow-up email
where they asked “whether it would be preferable to proceed with a Petition for
Exemption” under 21 C.F.R. § 1316.24. SER-5. Even if DEA’s response could
somehow be characterized as a determination, finding, or conclusion, it was certainly
not a final one. That would come, if ever, only after the petitioners pursued one of
5
Bennett establishes the test for finality under the APA, which provides for
judicial review of “final agency action.” 5 U.S.C. § 704. As the D.C. Circuit has
observed, however, there is “no reason” why “the word ‘final’ in § 877 should be
interpreted differently than the word ‘final’ in the APA.” John Doe, 484 F.3d at 566
n.4. This Court has applied Bennett’s test under other statutes that provide for judicial
review of “final” administrative actions. See, e.g., Alaska Dep’t of Envtl Conservation v.
U.S. EPA, 244 F.3d 748, 750 (9th Cir. 2001).
20
the available routes to requesting access to psilocybin and their application was
granted or denied. See John Doe, 484 F.3d at 566 (explaining that an agency action was
“definitive” and “not merely tentative” when “the DEA affirmatively denied [a]
permit application”).
Second, DEA’s guidance letter did not determine any rights or obligations or
give rise to any legal consequences. It did not order the petitioners do anything or
refrain from doing anything; it did not grant or deny a permit or license. The most
that could be said is that DEA conveyed its view that the Right to Try Act does not
provide an exemption from the CSA or its regulations. But as a general matter, “an
agency works no legal effect merely by expressing its view of the law.” Valero Energy
Corp. v. EPA, 927 F.3d 532, 536 (D.C. Cir. 2019) (quotation marks omitted). Thus,
this Court has held that there is no final action where an agency’s “letter simply
responds to [a] request for ‘assistance’ ” on a question of what law the agency would
apply to a permit application. City of San Diego v. Whitman, 242 F.3d 1097, 1102 (9th
Cir. 2001). The D.C. Circuit has likewise repeatedly held that the second prong of the
Bennett test is not satisfied where a letter “communicates the agency’s position on a
matter” but “compels action by neither the recipient nor the agency.” Holistic Candlers
& Consumers Ass’n v. FDA, 664 F.3d 940, 944 (D.C. Cir. 2012) (quotation marks
omitted); see also, e.g., Independent Equip. Dealers Ass’n v. EPA, 372 F.3d 420, 427 (D.C.
21
Cir. 2004) (Roberts, J.) (holding agency “advice letter” nonfinal where it “imposed no
obligations and denied no relief ” (quotation marks omitted)).
Nor did the DEA letter here “alter the legal regime” to which the petitioners
are subject. Bennett, 520 U.S. at 178. The letter was provided “simply to inform [the
petitioners] of what the law, previously enacted or adopted, is.” Golden & Zimmerman,
LLC v. Domenech, 599 F.3d 426, 432-33 (4th Cir. 2010) (addressing a reference guide
with frequently asked questions and answers). It “does not itself determine the law or
the consequences of not following it,” id. at 433, nor does it have (or claim to have)
any independent legal force. Valero Energy, 927 F.3d at 537. Rather, the DEA letter
“leaves the world just as it found it.” Id. at 536; Independent Equip. Dealers, 372 F.3d at
428. Any restrictions on the petitioners’ ability to access and use psilocybin flowed
directly from the CSA and its implementing regulations. See Gonzales v. Raich, 545 U.S.
1, 13-14 (2005) (describing the statutory scheme and its restrictions on Schedule I
substances). An agency action does not have legal consequences where a party’s
“obligation” to act arises under federal statute and regulations and “any penalty” for
not acting “would result from [the party’s] disregard of its statutory obligation.” Gallo
Cattle Co. v. U.S. Dep’t of Agric., 159 F.3d 1194, 1199 (9th Cir. 1998); see also Golden &
Zimmerman, 599 F.3d at 433.
This Court’s cases finding other types of agency action to be final underscore
what is lacking here. For example, DEA did not “orde[r]” the petitioners to refrain
from taking action “on pain of fines and imprisonment.” See San Francisco Herring
22
Ass’n v. Department of the Interior, 946 F.3d 564, 577 (9th Cir. 2019) (distinguishing
Golden & Zimmerman and Independent Equip. Dealers). Nor could DEA take action
against the petitioners “for failure to comply” with the letter, see Gill v. U.S. Dep’t of
Justice, 913 F.3d 1179, 1184-85 (9th Cir. 2019), or subject them to increased penalties,
see Alaska, 244 F.3d at 750; see also Sackett v. EPA, 566 U.S. 120, 126 (2012). The
DEA action at issue here does not “orde[r] sanctions for violations of its provisions.”
Ashcroft, 368 F.3d at 1120; Hemp Indus. Ass’n, 333 F.3d at 1085. Nor does it amend the
agency’s regulations, Hemp Indus. Ass’n. v. DEA, 357 F.3d 1012, 1015 (9th Cir. 2004),
or adjudicate an application, Mathew v. U.S. DEA, 472 F. App’x 453, 454 (9th Cir.
2012).
Agencies issue advice letters “countless times per year in dealing with the
regulated community.” Independent Equip. Dealers, 372 F.3d at 427 (quotation marks
omitted). Permitting every recipient of such a letter to sue over its contents “would
quickly muzzle any informal communications between agencies and their regulated
communities—communications that are vital to the smooth operation of both
government and business.” Id. at 428. The case law “rightly rejects that unwelcome
result.” Valero Energy, 927 F.3d at 538.
II. The DEA Letter Is Consistent With Law And Reasonably

Responded To The Petitioners’ Request For Guidance.
Assuming that the Court has jurisdiction to review DEA’s letter, the
petitioners’ arguments are without substance.
23
A. DEA Correctly Described The Scope Of The Right To Try

Act.
1. The Right to Try Act amended the FDCA to provide a new pathway by
which certain patients can gain access to certain medical products that have not been
approved by FDA. The statute provides that “[e]ligible investigational drugs provided
to eligible patients in compliance with this section are exempt from” specified
statutory and regulatory provisions of the FDCA that govern the labeling, approval,
and clinical trials of drugs. 21 U.S.C. § 360bbb-0a(b). An “eligible investigational
drug” is a drug that has not been approved by FDA but is at some stage of the review
process or is under active development or production and has not been discontinued
by the manufacturer or placed on a clinical hold by FDA. Id. § 360bbb-0a(a)(2).
The Right to Try Act provides no exemption from the CSA. Indeed, as the
States’ amicus brief recognizes, the statute “makes no mention of the Controlled
Substances Act or controlled substances” more generally. States Br. 5. DEA
correctly explained that the Right to Try Act “does not waive the requirements of any
provision of the Controlled Substances Act (CSA) or its implementing regulations”
and does not provide DEA with “authority to waive any of the CSA’s requirements.”
SER-3.
2. In arguing to the contrary, the petitioners rely primarily on 21 U.S.C. § 902,
the CSA’s longstanding savings provision. That section states: “Nothing in [the
CSA],” with some exceptions not relevant here, “shall be construed as in any way
24
affecting, modifying, repealing, or superseding the provisions of the Federal Food,
Drug, and Cosmetic Act.”
Section 902 does not suggest—and has never been understood to suggest—
that the restrictions on Schedule I drugs improperly supersede provisions of the
FDCA or that the provisions of the FDCA take precedence over the restrictions of
Schedule I. While their subject matter overlaps somewhat, each statute establishes its
own protocols and prohibitions, and FDA and DEA have complementary spheres of
authority. For example, applications to research in drugs that are classified as
controlled substances and have not received approval for marketing under the FDCA
must be approved by DEA and allowed to proceed by FDA. See 21 U.S.C. § 823(f );
21 U.S.C. 355(i); 21 C.F.R. pt. 312. Either agency can act to prevent the research
from going forward. But that does not mean that one agency has superseded or
interfered with the other’s statutory regime.
Nothing in the Right to Try Act alters that analysis. The Right to Try Act
exempts eligible investigational drugs from specifically identified requirements in the
FDCA. That exemption does not rescind the CSA or modify the restrictions that the
law places on Schedule I substances.6 The limited effect of the Right to Try Act is
6
The petitioners suggest (Br. 42) that FDA understands the Right to Try Act to
displace the CSA because the agency’s website answers a question about access to
“cannabis or cannabis-derived products for medical use through Right to Try”
without referring to the CSA. See FDA, FDA Regulation of Cannabis and Cannabis-
Derived Products, Including Cannabidiol (CBD) (Jan. 22, 2021),
25
underscored by a provision explaining that the Act does not “establish a positive
right” or any form of entitlement. Pub. L. No. 115-176, § 3(1), 132 Stat. at 1374.
Petitioners’ reliance on the Right to Try Act’s liability provision is similarly
misplaced. That provision states that “no liability in a cause of action shall lie against”
various parties involved with giving or denying access to an eligible investigational
drug in compliance with the Act. Pub. L. No. 115-176, § 2(b), 132 Stat. at 1374. As
an initial matter, it is not clear why the liability provision should have any bearing on
the analysis here, given that the Right to Try Act does not rescind the Schedule I
prohibitions and does not establish an entitlement to covered substances.
The petitioners and their amici would be wrong, in any event, to construe this
provision to bar the United States from enforcing federal law. See Br. 40, States Br.
13-15. The provision is directed at civil litigation by private parties, as evidenced by
the limits of the protections it provides. The provision shields various actors from
liability “unless the relevant conduct constitutes reckless or willful misconduct, gross
negligence, or an intentional tort.” Pub. L. No. 115-176, § 2(b)(1)(B), 132 Stat. at
https://go.usa.gov/x6VMN But FDA noted earlier on the same website that parts
of the cannabis plant are “controlled under the Controlled Substances Act (CSA)
since 1970 under the drug class ‘Marihuana.’” Id. Repetition was unnecessary.
Moreover, other parts of the cannabis plant and some cannabis-derived products are
not controlled substances, see id. (citing Agricultural Improvement Act of 2018, Pub.
L. No. 115-334, 132 Stat. 4490), making generalization impossible. In any event, as
FDA observed, the agency “is not involved” is decisions regarding access under the
Right to Try Act, id., and it had no need to weigh in on a matter outside its
jurisdiction.
26
1374. All of these address the scope of tort actions.7 Similarly, another “[l]imitation”
states that “[e]xcept as set forth,” the liability provision shall not “be construed to
modify or otherwise affect the right of any person to bring a private action under any
State or Federal product liability, tort, consumer protection, or warranty law.” Id.
§ 2(b)(3) (emphases added). A broad reading of this provision to exempt the Right to
Try Act from all liability under federal law would contravene Congress’s express
intention that the Act be “consistent with, and will act an alternative pathway
alongside, existing expanded access policies.” Id. § 3(4); cf. 21 U.S.C. 377(a) (providing
that “proceedings for the enforcement, or to restrain violations of [the FDCA] shall
be by and in the name of the United States,” except for certain actions by States
related to food).
7
The amici States argue that “Congress has referred to criminal ‘causes,’
‘actions,’ or ‘causes of actions’ on many occasions.” States Br. 15. But in all of the
examples the States cite, Congress used the word “criminal” to make the provisions
more broadly applicable. Such usage does not support the States’ argument that the
natural reading of “causes of action” without such a modifier would include criminal
or administrative enforcement. Black’s Law Dictionary, in fact, suggests the opposite.
See Cause of Action, Black’s Law Dictionary (11th ed. 2019) (defining “cause of action” to
mean “[a] group of operative facts giving rise to one or more bases for suing; a factual
situation that entitles one person to obtain a remedy in court from another person”).
The States’ invocation of the rule of lenity (States Br. 15) is similarly unhelpful. As
the Supreme Court previously explained in reviewing a conviction under the CSA,
that rule “is not an inexorable command to override common sense and evident
statutory purpose . . . ; it is satisfied if the words are given their fair meaning in accord
with the manifest intent of the lawmakers.” United States v. Moore, 423 U.S. 122, 145
(1975) (quotation marks omitted).
27
The consequences of the petitioners’ argument also weigh against the atextual
construction they advance. They contend that “[s]o long as a drug meets the
applicable investigational drug criteria, the drug’s source is irrelevant.” SER-10.
Thus, when the sponsor of clinical research in psilocybin declined to provide them
with the drug, they moved on to another company. SER-14. That company held a
DEA registration, but on the petitioners’ reading of the Right to Try Act, DEA would
be powerless to prevent an unscrupulous doctor from obtaining Schedule I
substances from an unregistered manufacturer outside the CSA’s “closed system of
distribution.” Wedgewood Vill. Pharmacy v. DEA, 509 F.3d 541, 542 (D.C. Cir. 2007)
(quotation marks omitted). Further, the petitioners do not seek psilocybin to treat the
life-threatening disease that triggers “eligible patient” status under the Right to Try
Act. Rather, they seek to treat depression and anxiety, ER-26, common conditions
among the general populace and almost certainly more common among those with
life-threatening conditions.
Given the number of possible manufacturers and consumers, the petitioners’
theory would “have a significant impact on both the supply and demand sides of the
market” for psilocybin. Raich, 545 U.S. at 30. The likelihood that production “will
precisely match the patients’ medical needs during their convalescence seems remote;
whereas the danger that excesses will satisfy some of the . . . demand for recreational
use seems obvious.” Id. at 32. And the persistent existence of the narcotics trade
despite criminal enforcement efforts “suggests that no small number of unscrupulous

28
people will make use of [the Right to Try] exemptions to serve their commercial needs
whenever it is feasible to do so.” Id. Application of the CSA to restrict the use of
psilocybin by patients with life-threatening conditions thus furthers the CSA’s main
objectives “to conquer drug abuse and to control the legitimate and illegitimate traffic
in controlled substances.” Id. at 12.
Had Congress meant to limit federal enforcement of the Controlled Substances
Act, it would have said so explicitly. The Right to Try Act’s liability provision plainly
does not accomplish that extraordinary result. The Supreme Court has repeatedly
emphasized that Congress “does not alter the fundamental details of a regulatory
scheme in vague terms or ancillary provisions.” Whitman v. American Trucking Ass’ns,
531 U.S. 457, 468, (2001). It did not do so here.
3. The petitioners and their amici go astray when they argue that the Right to
Try Act should be read to rescind portions of the CSA in the absence of a clear
statement by Congress to preserve them. They urge (Br. 46-49, 51-55; States Br. 22-
23; ACLU-W Br. 13-25) that principles of federalism require a clear statement to
preserve existing restrictions on Schedule I substances because the regulation of
medicine is traditionally the province of state governments. But federal law, including
the CSA and the FDCA, has long regulated drugs for use in medical treatment. See,
e.g., Raich, 545 U.S. at 27 (“[T]he CSA is a comprehensive regulatory regime
specifically designed to regulate which controlled substances can be utilized for
medicinal purposes, and in what manner.”). While this inevitably affects the options
29
available to physicians, it does not mean that these statutes impermissibly regulate the
practice of medicine as traditionally understood. See, e.g., United States v. 9/1 Kg.
Containers, 854 F.2d 173, 176-77 (7th Cir. 1988) (explaining that phrases like the
practice of medicine have “never meant more than that medical licensure and
discipline would continue to be the states’ business”); United States v. Evers, 643 F.2d
1043, 1048 (5th Cir. 1981) (“[W]hile the [FDCA] was not intended to regulate the
practice of medicine, it was obviously intended to control the availability of drugs for
prescribing by physicians.”); see also United States v. Regenerative Scis., LLC, 741 F.3d
1314, 1320 (D.C. Cir. 2014) (refusing to construe the FDCA in a manner that “would
allow states to gut the FDCA’s regulation of doctors, and thereby create an enormous
gap in the FDCA’s coverage, by classifying the distribution of drugs by doctors as the
practice of medicine”).
Indeed, even where state laws expressly authorize medicinal use of controlled
substances—creating the strongest possible federalism concerns—the CSA
supersedes them. See, e.g., Raich, 545 U.S. at 5 (holding that Congress could properly
“prohibit the local cultivation and use of marijuana in compliance with California
law”); United States v. Canori, 737 F.3d 181, 184 (2d Cir. 2013) (“Marijuana remains
illegal under federal law, even in those states in which medical marijuana has been
legalized.”). The petitioners get matters exactly backwards when they contend (Br.
48-49) that “DEA must respect the varying lines states have drawn regarding access to
schedule I substances under RTT laws.”

30
Petitioners’ reliance (Br. 46-48) on Gonzales v. Oregon, 546 U.S. 243 (2006),
further illustrates the errors of their analysis. In that case, the Supreme Court set
aside an interpretive rule issued by the Attorney General that purported to bar the
(otherwise lawful) prescription of controlled substances under Oregon’s assisted
suicide law because, in his view, “[a]ssisting suicide is not a ‘legitimate medical
purpose.’ ” Id. at 254 (quoting 66 Fed. Reg. 56,607, 56,608 (Nov. 9, 2001)). Here, in
contrast, the petitioners seek an exemption from a Schedule I prohibition with regard
to a substance placed on Schedule I by Congress itself. This is a category reserved for
those drugs that have “no currently accepted medical use in treatment in the United
States” and for which all access is denied except for specifically approved research
projects. 21 U.S.C. §§ 812(b)(1), (c), 823(f ); see United States v. Oakland Cannabis Buyers’
Coop., 532 U.S. 483, 489-90 (2001). It was therefore “clear from the text of the [CSA]
that Congress has made a determination that [psilocybin] has no medical benefits
worthy of an exception.” 532 U.S. at 493. Given the longstanding restrictions
Congress has imposed on such substances—not to mention its subsequent
affirmation that drugs listed in Schedule I should remain there, see Pub. L. No. 105-
277, div. F, 112 Stat. at 2681-760 to -761—the petitioners’ insistence that Congress
was required to “clearly state” (Br. 51) that it was not setting aside those restrictions
when it amended a different statute is difficult to understand.
31
The canon of interpretation most clearly implicated by this reasoning is not any
federalism principle but the “cardinal rule” that “repeals by implication are not
favored.” Morton v. Mancari, 417 U.S. 535, 549 (1974) (quoting Posadas v. National City
Bank, 296 U.S. 497, 503 (1936)). Courts presume that “Congress will specifically
address preexisting law when it wishes to suspend its normal operations in a later
statute.” Epic Sys. Corp. v. Lewis, 138 S. Ct. 1612, 1624 (2018) (quotation marks
omitted). Congress did so in the Right to Try Act, which carefully identifies the legal
provisions it suspends but does not mention the CSA. “When two statutes are
capable of co-existence, it is the duty of the courts, absent a clearly expressed
congressional intention to the contrary, to regard each as effective.” FCC v. NextWave
Pers. Commc’ns, Inc., 537 U.S. 293, 304 (2003) (brackets and quotation marks omitted).
It is therefore not DEA’s interpretation that would require a clear statement, but the
petitioners’.
Petitioners are equally wide of the mark in invoking principles of constitutional
avoidance (Br. 55-57), on the ground that preserving an existing restriction infringes
on protected liberty interests. This canon has “no application” where, as here, a
statute is unambiguous. Oakland Cannabis Buyers’ Coop., 532 U.S. at 494 (declining to
apply the canon to the CSA). In any event, courts have consistently rejected the claim
that “the Constitution provides an affirmative right of access to particular medical
treatment reasonably prohibited by the Government.” Abigail Alliance for Better Access
32
to Developmental Drugs v. von Eschenbach, 495 F.3d 695, 710 & n.18 (D.C. Cir. 2007)
(collecting examples).
B. The DEA Letter Did Not Address Other Matters And Was
Not Arbitrary Or Capricious.
When the petitioners wrote to DEA, they explained that they sought psilocybin
“pursuant to the Washington and U.S. Right to Try (RTT) Acts” and sought the
agency’s “guidance” on how they could obtain the drug under those statutes. ER-4.
In response, DEA explained that the Right to Try Act “does not waive the
requirements of any provision of the Controlled Substances Act (CSA) or its
implementing regulations.” SER-3. Thus, the agency stated that it “has no authority
to waive any of the CSA’s requirements pursuant to the RTT.” Id.
The petitioners urge (Br. 57-58) that DEA has other authorities to waive
certain statutory or regulatory requirements. Even if that were the case, it would have
no bearing on DEA’s statement regarding the scope of its authority under the statute
that generated the petitioners’ inquiry. The agency did not opine on any other
potential statutory or regulatory authority. There is no basis for this Court to consider
in the first instance the potential merits of arguments regarding agency authorities not
addressed in a letter responding to a request for guidance regarding the Right to Try
Act.
Regardless, the provisions cited by the petitioners do not support their
arguments. The statutory provisions the petitioners cite provide DEA with
33
rulemaking authority. See 21 U.S.C. § 822(d) (permitting waiver “by regulation” of
registration requirements); Oregon, 546 U.S. at 259 (describing 21 U.S.C. §§ 821 and
871(b)). But the agency has not undertaken a rulemaking, and the petitioners did not
ask them to do so. The petitioners also point to a DEA regulation that permits a
person to apply for an exception to any DEA regulation. 21 C.F.R. § 1307.03. But
they did not request any such exception, and this provision does not permit DEA to
waive any statutory prohibition. The petitioners urge that “[p]ermitting use of a
schedule I drug under RTT amounts to treating it as a schedule II substance for that
discrete purpose.” Br. 53. But the CSA requires that any rescheduling follow “a
detailed set of procedures,” including an evaluation and recommendation from the
Secretary of Health and Human Services and a formal rulemaking on the record.
Oregon, 546 U.S. at 260.
The petitioners’ argument (Br. 60-63) that DEA departed from prior practice is
equally unavailing. DEA has not previously addressed the Right to Try Act or taken
(or declined to take) any action under it, so there is no relevant past practice here.
And because DEA did not grant or deny any specific relief under the CSA, any
previous history with respect to such actions was not relevant to the matters
addressed in the advice letter.
The petitioners’ argument (Br. 63-66) that DEA has inconsistently relied on the
FDCA to determine “currently accepted medical use” presents another variation on
an unsuccessful theme. In 1992, the agency explained its understanding of that

34
phrase—a requirement under the CSA for placement of a drug in Schedule I—and
laid out a five-factor test for determining whether a drug has such a use. See 57 Fed.
Reg. 10,499, 10,503-04, 10,506 (Mar. 26, 1992); see also Alliance for Cannabis Therapeutics
v. DEA, 15 F.3d 1131, 1134-35 (D.C. Cir. 1994) (rejecting a claim that DEA had
unreasonably interpreted the statute). DEA had no cause to reconsider or to apply
that interpretation in response to a letter seeking advice on the scope of the Right to
Try Act. That Act provides limited exemptions to specific provisions of the FDCA
governing the distribution of investigational drugs. It did not approve any medical
treatment, nor did it affect the scheduling of any controlled substances.
If the petitioners believe that psilocybin should be moved to another schedule
so that doctors may prescribe it as a therapeutic treatment, they are free to seek
legislative action, see, e.g., Pub. L. No. 115-334, § 12619, 132 Stat. at 5018 (removing
hemp from the CSA), or to petition the agency for a rescheduling, see, e.g., Alliance for
Cannabis Therapeutics, 15 F.3d at 1131 (describing the history of such petitions for
marijuana). But nothing in the Right to Try Act disturbed the restrictions on
Schedule I substances or Congress’s judgment placing psilocybin in that category.
DEA did not err in saying so.
35
CONCLUSION
For the foregoing reasons, the petition for review should be dismissed for lack
of jurisdiction or denied.
Respectfully submitted,
BRIAN M. BOYNTON
MARK B. STERN
s/ Thomas Pulham
THOMAS PULHAM
(202) 514-4332
thomas.pulham@usdoj.gov
June 2021
36
STATEMENT OF RELATED CASES
Pursuant to Ninth Circuit Rule 28-2.6, respondents state that they know of no
related case pending in this Court.
s/ Thomas Pulham
Thomas Pulham
CERTIFICATE OF COMPLIANCE
This brief complies with the type-volume limit of Federal Rule of Appellate
Procedure 32(a)(7)(B) because it contains 9,134 words. This brief also complies with
the typeface and type-style requirements of Federal Rule of Appellate Procedure
32(a)(5)-(6) because it was prepared using Microsoft Word 2016 in Garamond 14-
point font, a proportionally spaced typeface.
s/ Thomas Pulham
Thomas Pulham
ADDENDUM
TABLE OF CONTENTS
21 U.S.C. § 360bbb-0a ...........................................................................................................A1
21 U.S.C. § 812........................................................................................................................A4
Pub. L. No. 115-176...............................................................................................................A6

21 U.S.C. § 360bbb-0a
§ 360bbb-0a. Investigational drugs for use by eligible patients.
(a) Definitions
For purposes of this section—
(1) the term “eligible patient” means a patient—
(A) who has been diagnosed with a life-threatening disease or condition (as
defined in section 312.81 of title 21, Code of Federal Regulations (or any
successor regulations));
(B) who has exhausted approved treatment options and is unable to participate
in a clinical trial involving the eligible investigational drug, as certified by a
physician, who—
(i) is in good standing with the physician's licensing organization or board; and
(ii) will not be compensated directly by the manufacturer for so certifying; and
(C) who has provided to the treating physician written informed consent
regarding the eligible investigational drug, or, as applicable, on whose behalf a
legally authorized representative of the patient has provided such consent;
(2) the term “eligible investigational drug” means an investigational drug (as such
term is used in section 360bbb of this title)—
(A) for which a Phase 1 clinical trial has been completed;
(B) that has not been approved or licensed for any use under section 355 of
this title or section 351 of the Public Health Service Act;
(C)(i) for which an application has been filed under section 355(b) of this title
or section 351(a) of the Public Health Service Act; or
(ii) that is under investigation in a clinical trial that—
(I) is intended to form the primary basis of a claim of effectiveness in support
of approval or licensure under section 355 of this title or section 351 of the
Public Health Service Act; and
(II) is the subject of an active investigational new drug application under
section 355(i) of this title or section 351(a)(3) of the Public Health Service
Act, as applicable; and
(D) the active development or production of which is ongoing and has not
been discontinued by the manufacturer or placed on clinical hold under section
355(i) of this title; and
A1
(3) the term “phase 1 trial” means a phase 1 clinical investigation of a drug as
described in section 312.21 of title 21, Code of Federal Regulations (or any
successor regulations).
(b) Exemptions
Eligible investigational drugs provided to eligible patients in compliance with this
section are exempt from sections 352(f ), 353(b)(4), 355(a), and 355(i) of this title,
section 351(a) of the Public Health Service Act, and parts 50, 56, and 312 of title 21,
Code of Federal Regulations (or any successor regulations), provided that the sponsor
of such eligible investigational drug or any person who manufactures, distributes,
prescribes, dispenses, introduces or delivers for introduction into interstate
commerce, or provides to an eligible patient an eligible investigational drug pursuant
to this section is in compliance with the applicable requirements set forth in sections
312.6, 312.7, and 312.8(d)(1) of title 21, Code of Federal Regulations (or any successor
regulations) that apply to investigational drugs.
(c) Use of clinical outcomes
(1) In general
Notwithstanding any other provision of this chapter, the Public Health Service
Act, or any other provision of Federal law, the Secretary may not use a clinical
outcome associated with the use of an eligible investigational drug pursuant to this
section to delay or adversely affect the review or approval of such drug under
section 355 of this title or section 351 of the Public Health Service Act unless—
(A) the Secretary makes a determination, in accordance with paragraph (2), that
use of such clinical outcome is critical to determining the safety of the eligible
investigational drug; or
(B) the sponsor requests use of such outcomes.
(2) Limitation
If the Secretary makes a determination under paragraph (1)(A), the Secretary shall
provide written notice of such determination to the sponsor, including a public
health justification for such determination, and such notice shall be made part of
the administrative record. Such determination shall not be delegated below the
director of the agency center that is charged with the premarket review of the
eligible investigational drug.
(d) Reporting
(1) In general
A2
The manufacturer or sponsor of an eligible investigational drug shall submit to the

Secretary an annual summary of any use of such drug under this section. The
summary shall include the number of doses supplied, the number of patients
treated, the uses for which the drug was made available, and any known serious
adverse events. The Secretary shall specify by regulation the deadline of
submission of such annual summary and may amend section 312.33 of title 21,
Code of Federal Regulations (or any successor regulations) to require the
submission of such annual summary in conjunction with the annual report for an
applicable investigational new drug application for such drug.
(2) Posting of information
The Secretary shall post an annual summary report of the use of this section on
the internet website of the Food and Drug Administration, including the number
of drugs for which clinical outcomes associated with the use of an eligible
investigational drug pursuant to this section was—
(A) used in accordance with subsection (c)(1)(A);
(B) used in accordance with subsection (c)(1)(B); and
(C) not used in the review of an application under section 355 of this title or
section 351 of the Public Health Service Act.
A3
21 U.S.C. § 812 (excerpts)

§ 812. Schedules of controlled substances.
(a) Establishment
There are established five schedules of controlled substances, to be known as
schedules I, II, III, IV, and V. Such schedules shall initially consist of the substances
listed in this section. The schedules established by this section shall be updated and
republished on a semiannual basis during the two-year period beginning one year after
October 27, 1970, and shall be updated and republished on an annual basis thereafter.
(b) Placement on schedules; findings required
Except where control is required by United States obligations under an international
treaty, convention, or protocol, in effect on October 27, 1970, and except in the case
of an immediate precursor, a drug or other substance may not be placed in any
schedule unless the findings required for such schedule are made with respect to such
drug or other substance. The findings required for each of the schedules are as
follows:
(1) Schedule I—
(A) The drug or other substance has a high potential for abuse.
(B) The drug or other substance has no currently accepted medical use in
treatment in the United States.
(C) There is a lack of accepted safety for use of the drug or other substance
under medical supervision.
(2) Schedule II—
(A) The drug or other substance has a high potential for abuse.
(B) The drug or other substance has a currently accepted medical use in
treatment in the United States or a currently accepted medical use with severe
restrictions.
(C) Abuse of the drug or other substances may lead to severe psychological or
physical dependence.
(3) Schedule III—
(A) The drug or other substance has a potential for abuse less than the drugs or
other substances in schedules I and II.
A4
(C) Abuse of the drug or other substance may lead to moderate or low physical
dependence or high psychological dependence.
(4) Schedule IV—
(A) The drug or other substance has a low potential for abuse relative to the
drugs or other substances in schedule III.
(C) Abuse of the drug or other substance may lead to limited physical
dependence or psychological dependence relative to the drugs or other
substances in schedule III.
(5) Schedule V—
(A) The drug or other substance has a low potential for abuse relative to the
drugs or other substances in schedule IV.
(C) Abuse of the drug or other substance may lead to limited physical
dependence or psychological dependence relative to the drugs or other
substances in schedule IV.
(c) Initial schedules of controlled substances
Schedules I, II, III, IV, and V shall, unless and until amended1 pursuant to section
811 of this title, consist of the following drugs or other substances, by whatever
official name, common or usual name, chemical name, or brand name designated:
Schedule I
…
(c) Unless specifically excepted or unless listed in another schedule, any material,
compound, mixture, or preparation, which contains any quantity of the following
hallucinogenic substances, or which contains any of their salts, isomers, and salts of
isomers whenever the existence of such salts, isomers, and salts of isomers is possible
within the specific chemical designation:
…
(15) Psilocybin.
…
…
A5
Pub. L. No. 115-176 (excerpts)

…
§ 3. Sense of the Senate.
It is the sense of the Senate that section 561B of the Federal Food, Drug, and
Cosmetic Act, as added by section 2—
(1) does not establish a new entitlement or modify an existing entitlement, or
otherwise establish a positive right to any party or individual;
(2) does not establish any new mandates, directives, or additional regulations;
(3) only expands the scope of individual liberty and agency among patients, in
limited circumstances;
(4) is consistent with, and will act as an alternative pathway alongside, existing
expanded access policies of the Food and Drug Administration;
(5) will not, and cannot, create a cure or effective therapy where none exists;
(6) recognizes that the eligible terminally ill patient population often consists of
those patients with the highest risk of mortality, and use of experimental
treatments under the criteria and procedure described in such section 561A
involves an informed assumption of risk; and
(7) establishes national standards and rules by which investigational drugs may be
provided to terminally ill patients.
A6
No. 21-70544
IN THE UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT
ADVANCED INTEGRATIVE MEDICAL SCIENCE INSTITUTE, PLLC, et al.,
Petitioners,
v.
MERRICK B. GARLAND, Attorney General, et al.,
Respondents.
On Petition for Review of a Non-Final Action of the Drug Enforcement

Administration
SUPPLEMENTAL EXERPTS OF RECORD

Volume 1 of 1
BRIAN M. BOYNTON
MARK B. STERN
THOMAS PULHAM
(202) 514-4332
INDEX
Page
Letter from Thomas W. Prevoznik, Deputy Assistant Administrator,

Diversion Control Division, DEA, to Kathryn Tucker
(February 12, 2021) ..................................................................................................................... 3
Email from Kathryn Tucker to John Purcell, Diversion Control Division, DEA
(February 2, 2021) ..................................................................................................................... 5
Email from Howard Sard, Organix, Inc., to Brian Donahue, DEA

(December 18, 2020) ................................................................................................................... 8
SER-2

From: Kathryn Tucker <kathryn@emergelawgroup.com>
Sent: Tuesday, February 2, 2021 1:03 PM
To: Purcell, John J. <JPurcell@dea.usdoj.gov>
Cc: Danner-Ryan, Heather A. <HADanner-Ryan@dea.usdoj.gov>; Dizon, Edwin S
<ESDizon@dea.usdoj.gov>
Subject: Re: Right to Try psilocybin

Hello John:
I recognize that DEA has not yet addressed how it will accommodate the Right to Try
(RTT) law. As DEA works to determine this, it occurred to me that perhaps another way for it
to do so would be to issue an exemption from prosecution from the CSA to Dr. Aggarwal
for treating his patients with psilocybin under Right to Try. Dr. Aggarwal and his patients
would be willing to provide affidavits delineating the scope of the RTT use (ie. specifying the
quantity of psilocybin, record keeping, and security measures etc).
Under this approach, it would be necessary for DEA to make clear that the exemption
would permit the manufacturer/distributor (Organix ) to supply its psilocybin to Dr. Aggarwal
for RTT purposes.
This approach would be something akin to what is provided for in 21 C.F.R. §
1316.24, Exemption from prosecution for researchers, although the use would be
therapeutic rather than ‘research’ in the traditional sense.
As you may be aware, exemptions have been granted on similar facts in Canada by the
Canadian Health Ministry. Information about the Canadian exemptions can be found here on
the Therapsil website: https://therapsil.ca/about/

Please provide DEA’s guidance on whether it would be preferable to proceed with a
Petition for Exemption. I remind you that the patients are in advanced stage of cancer and
time is of the essence to accommodate their rights under RTT.

Thank you.
KT

Kathryn Tucker | Special Counsel
EMERGE LAW GROUP
621 SW Morrison Street, Suite 900
Portland, OR 97205
O: 503.227.4525 F: 503.200.1124 D: 206.595.0097
E: kathryn@emergelawgroup.com
}}} emergelawgroup.com

This communication and any attachments may contain privileged or confidential information intended for a specific
individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this
SER-5
communication and any attachments, and are notified that any disclosure, copying or distribution of this
communication and any attachments, or the taking of any action based on it, is strictly prohibited.

Date: Sunday, January 24, 2021 at 11:19 AM
To: "john.purcell@usdoj.gov" <john.purcell@usdoj.gov>
Cc: "Heather.A.Danner-Ryan@usdoj.gov" <Heather.A.Danner-Ryan@usdoj.gov>,
"Edwin.S.Dizon@usdoj.gov" <Edwin.S.Dizon@usdoj.gov>
Subject: Re: Right to Try psilocybin
Hello John:
Thanks so much for your call on Friday, advising you are in receipt of my letter dated 1/15/21,
regarding the AIMS Institute and Dr. Sunil Aggarwal. I am copying you on my email of
1/15/21, the initial transmission of the letter via email, to introduce you to the field officers I
have been in touch with about this matter. Because of the urgency of this matter for my
clients, we hope you will be able to provide guidance on which form of registration Dr.
Aggarwal ought seek in order to obtain psilocybin for therapeutic use with his terminally ill
patients pursuant to Right to Try. The dying patients do not have the time for a drawn out
proceeding, as I hope you can appreciate.
If it would facilitate faster action on this matter, Dr. Aggarwal is willing to proceed with filing
a registration, for example as a researcher, which was suggested by one of the field officers,
even though it seems not quite to fit the present situation.
We await your guidance. Thank you for your prompt attention to this matter.
KT

EMERGE LAW GROUP
Portland, OR 97205
O: 503.227.4525 F: 503.200.1124 D: 206.595.0097

Date: Friday, January 15, 2021 at 3:57 PM
To: "dea.registration.help@usdoj.gov" <dea.registration.help@usdoj.gov>
Cc: "Heather.A.Danner-Ryan@usdoj.gov" <Heather.A.Danner-Ryan@usdoj.gov>,
"Edwin.S.Dizon@usdoj.gov" <Edwin.S.Dizon@usdoj.gov>
Subject: Right to Try psilocybin
SER-6
Dear DEA Officials:

I have had the opportunity to speak with both Ms. Danner-Ryan(Boston Field Office) and Mr.
Dizon( Seattle Field Office) about the matter discussed in the attached letter, which is also
being sent via Registered Mail. Neither official could clarify which registration status my
client should seek in the present situation. We appreciate your prompt attention to, and
guidance about, this matter, as the interests of terminally ill patients are at stake and time is of
the essence.
Thank you,
KT
EMERGE LAW GROUP
Portland, OR 97205
O: 503.227.4525 F: 503.200.1124 D: 206.595.0097
SER-7
From: Donahue, Brian F. <BFDonahue@dea.usdoj gov>

Sent: Friday, December 18, 2020 5:39 PM
To: Danner-Ryan, Heather A. <HADanner-Ryan@dea.usdoj gov>
Subject: Fwd: psilocybin
Please see below. Not sure who can answer this.
Thank you,
Brian Donahue
Diversion Investigator
DEA Boston Field Division

JFK Federal Building
15 New Sudbury St. Room E-400 | Boston, MA 02203
p. 571-362-9041 | f. 617-557-2126 | e. Brian.F.Donahue@usdoj.gov
Begin forwarded message:
From: Howard Sard <sard@organixinc.com>

Date: December 18, 2020 at 5:13:50 PM EST
To: "Donahue, Brian F." <BFDonahue@dea.usdoj.gov>, Paul Blundell <blundell@organixinc.com>
Subject: Fwd: psilocybin
Reply-To: sard@organixinc.com
Hi Brian,
We have been approached by a medical group in Portland Oregon seeking to obtain psilocybin (Schedule I) from
us for use in a palliative care setting, however, they do not have a DEA Schedule I license. In summary, they would
like to receive the psilocybin under the 'Right to Try' act. I have told them that unless we hear otherwise from
DEA, we can only provide psilocybin to an entity with a DEA Schedule I license. They have asked me to inquire
with DEA and so I have forwarded the entire email trail below. Could you please pass this on to the appropriate
department in Headquarters if appropriate? Thanks!
Regards,
Howard
SER-8
-------- Forwarded Message --------

Subject:Re: psilocybin
Date:Fri, 18 Dec 2020 19:32:01 +0000
From:Kathryn Tucker
To:sard@organixinc.com , Paul Blundell
CC:Sunil Aggarwal

Great, thanks so much.

As noted, I anticipate that this will be the first time DEA has been alerted to the application of RTT
to psilocybin. I would imagine a fair bit of ramp up will be required. My team, which includes a leading
law firm with specialized expertise in FDA and DEA matters, is available to assist with that and would be
pleased to do so.
Should the DEA take the erroneous position that RTT does not allow access to psilocybin, it would
be a matter well worth taking up for judicial review. The courts, of course, are the final arbiter about the
reach and application of a statute. Because psilocybin can be so tremendously effective as a therapy to
relieve anxiety and depression suffered by terminally ill patients, we are eager to clarify that it is an EID
under RTT.
Should consideration of judicial review become appropriate, my team is in position to take a lead
role in any such action. We consider this a public interest matter and would not look to Organix to cover
the costs, though we would be pleased to work collaboratively with your chosen counsel to make the
strongest case possible.
Best,
KT

EMERGE LAW GROUP
Portland, OR 97205
O: 503.227.4525 F: 503.200.1124 D: 206 595 0097
E: kathryn@emergelawgroup com

This communication and any attachments may contain privileged or confidential information intended for a specific individual and
purpose, and is protected by law If you are not the intended recipient, you should delete this communication and any
attachments, and are notified that any disclosure, copying or distribution of this communication and any attachments, or the
taking of any action based on it, is strictly prohibited

From: Howard Sard
Organization: Organix, Inc.
Reply-To: "sard@organixinc.com"
Date: Friday, December 18, 2020 at 11:23 AM
To: Kathryn Tucker , Paul Blundell
Cc: Sunil Aggarwal
Subject: Re: psilocybin

Hi Kathryn,
I will inquire with DEA, referencing your email to us of Dec-15-2020, and provide your contact information to DEA if
they request.
Regards,
Howard
Howard Sard, Ph.D

Vice President,
Organix, Inc.
240 Salem Street,
Woburn, MA 01801
781-932-4142
sard@organixinc.com
www.organixinc.com

_______________________________________________________________________________________

This electronic message and any attachment is Organix Inc. confidential information
intended for the individual or individuals named above. If the reader is not the
intended recipient, you are hereby notified that any use, dissemination, distribution,
or copying of this communication is strictly prohibited. If you have received this
communication in error, please delete the original message. Thank you.
_______________________________________________________________________________________
On 12/16/2020 3:49 PM, Kathryn Tucker wrote:
Hi Friends:
As to your suggestion that you would inquire with your DEA contact about the
SER-9
propriety of Organix supplying psilocybin to Dr. Aggarwal for his use with his terminally ill
patients at the AIMS clinic, pursuant to Right to Try. We agree that this would be
appropriate. As mentioned, it is likely the DEA will not be familiar with such a request, and
will need to come to speed on the RTT and its application in context of this particular
investigational drug. I hope you can share my message of 12/15 with the DEA when you
make inquiry. I would be pleased to provide additional information about this to the DEA
official as they consider the matter.
We are proceeding in a manner consistent with both the federal RTT and the
Washington State RTT, since Dr. Aggarwal, his clinic and patients, are located in
Washington. The Washington RTT can be found at RCW 69.77 et seq.
Thank you for your interest in ensuring that those entitled to legally access psilocybin
are able to obtain this investigational drug.
KT

EMERGE LAW GROUP
Portland, OR 97205
O: 503 227.4525 F: 503.200.1124 D: 206.595 0097
}}} emergelawgroup com
individual and purpose, and is protected by law If you are not the intended recipient, you should delete this
communication and any attachments, or the taking of any action based on it, is strictly prohibited
From: Kathryn Tucker

Date: Tuesday, December 15, 2020 at 4:12 PM
To: "sard@organixinc.com" , Paul Blundell
Cc: Sunil Aggarwal
Hello Friends at Organix:

We believe there is a clear exception to your statement that you can “only ship a DEA
Schedule I compound such as psilocybin upon receipt of a copy of the requesting
organization's current DEA Schedule I license and a properly filled out DEA 222 form.”
Some drugs, which are otherwise prohibited, are intended to be accessible in certain
situations under the “Right to Try” (RTT) act, adopted by the federal government in 2018. 21
U.S.C. § 360bbb-0a (2018). See generally, https://www.fda.gov/patients/learn-about-
expanded-access-and-other-treatment-options/right-try.
The purpose of RTT is to allow terminally ill patients access to drugs still in
investigational stages because such patients do not have the luxury of time to await the slow
process of new drug approval. Psilocybin meets the requirements to qualify as such a drug.
To qualify as an eligible investigational drug (“EID”) under the RTT, a drug must
satisfy four requirements. First, it must have completed an FDA-approved Phase I clinical
trial. Second, the drug must not be approved or licensed for any use through the federal Food,
Drug, and Cosmetic Act (“FD&C Act”) or the Public Health Services Act (“PHSA”) Third,
the drug must either: (a) have an application filed under the FD&C Act or PHSA, or (b) be
under investigation in a clinical trial that is “intended to form the primary basis of a claim of
effectiveness in support of approval” and be the subject of an active IND application under the
FD&C Act or PHSA. Fourth, the drug’s active development and production must be ongoing,
not discontinued by the manufacturer, and not subject to a clinical hold. 21 U.S.C. § 360bbb-
0a(a)(2)(A)-(D).
Under the RTT, an EID must be the subject of an IND application. 21 U.S.C. § 360bbb-
0a(a)(2)(C). So long as a drug meets the applicable investigational drug criteria, the drug’s
source is irrelevant.
The exemptions under the federal RTT are broadly worded to apply to a variety of
different parties that might handle the EID including: “[…] the sponsor of such eligible
investigational drug or any person who manufactures, distributes, prescribes, dispenses,
introduces or delivers for introduction into interstate commerce, or provides to an eligible
patient an eligible investigational drug.” 21 U.S.C. § 360bbb-0a(b). The RTT exempts the
qualifying EID from the federal prohibition against placing a “new drug” into interstate
commerce without approval from the FDA. Id.; see also 21 U.S.C. § 355(a). The exemptions
are connected to the qualifying EID itself.
The goal of the RTT is to increase access for terminally ill patients to investigational
new drugs; a patient may obtain an eligible investigational drug from any manufacturer willing
to provide it.
The Right to Try is the law of the nation. It protects access to eligible investigational
drugs for terminally ill patients. Psilocybin meets the requirements to be deemed an eligible
investigational drug. We hope you will consider this additional information as you consider
this request.
If you prefer to have me discuss these particulars with your counsel, I would welcome
SER-10
the opportunity to do so.

Thanks for your consideration of this request. We appreciate it may be the first time
you have been asked to supply this investigational drug pursuant to the RTT.
Best,
KT

EMERGE LAW GROUP
Portland, OR 97205
O: 503.227.4525 F: 503.200.1124 D: 206.595.0097
}}}emergelawgroup.com

This communication and any attachments may contain privileged or confidential information
intended for a specific individual and purpose, and is protected by law. If you are not the
intended recipient, you should delete this communication and any attachments, and are
notified that any disclosure, copying or distribution of this communication and any
attachments, or the taking of any action based on it, is strictly prohibited.

From: Howard Sard
Date: Tuesday, December 15, 2020 at 2:14 PM
To: Sunil Aggarwal , Kathryn Tucker
Cc: Paul Blundell

Hi Dr. Aggarwal,
Thank you for your inquiry. I do believe that psychedelics can play a valuable role in many areas of
medicine, and Organix is committed to assisting researchers whenever possible with these important
programs. However, our business operates under DEA regulations, and we can only ship a DEA
Schedule I compound such as psilocybin upon receipt of a copy of the requesting organization's current
DEA Schedule I license and a properly filled out DEA 222 form.
Regards,
Howard
Howard Sard, Ph.D

Vice President,
Organix, Inc.
240 Salem Street,
Woburn, MA 01801
781-932-4142
sard@organixinc.com
www.organixinc.com

_______________________________________________________________________________________

This electronic message and any attachment is Organix Inc. confidential
information
intended for the individual or individuals named above. If the reader is not
the
intended recipient, you are hereby notified that any use, dissemination,
distribution,
or copying of this communication is strictly prohibited. If you have
received this
communication in error, please delete the original message. Thank you.
_______________________________________________________________________________________
On 12/10/2020 12:11 AM, Sunil Aggarwal wrote:
Hi Howard, I wanted to introduce myself. I'm Sunil Aggarwal, a practicing hospice and
palliative medicine physician who is making the right to try request on behalf of two of
my patients who have terminal illnesses. I have attached here two witnessed signed
consent forms for these requests as required under the Washington state law.

We are set up at our clinic for psilocybin-assisted psychotherapy sessions, as we have
been practicing with ketamine-assisted psychotherapy for over two years. I have also
received MDMA assisted therapy training through MAPS. I believe I have seen your
psilocybin crystals when I was training at NYU and was getting a tour by Dr. Stephen
Ross. I would be grateful if you would be willing to supply your psilocybin product for
my patients under the state and federal right to try laws, or explore how we might
achieve this.
Thank you,
Sunil Aggarwal

SER-11
Date: Thursday, December 3, 2020 at 12:00 PM

To: Kathryn Tucker <kathryn@emergelawgroup.com>
Cc: Paul Blundell <blundell@organixinc.com>, Sunil Aggarwal
<saggarwal@aimsinstitute.net>
Hi KT,
I can forward your email, with your permission, to our local DEA office, and find out their
view on this.
Without explicit permission from DEA, we cannot ship a Schedule I compound except to
a Schedule I license holder.
Regards,
Howard
Howard Sard, Ph.D

Vice President,
Organix, Inc.
240 Salem Street,
Woburn, MA 01801
781-932-4142
sard@organixinc.com
www.organixinc.com
_______________________________________________________________________________________
This electronic message and any attachment is Organix Inc.
confidential information
intended for the individual or individuals named above. If the
reader is not the
intended recipient, you are hereby notified that any use,
dissemination, distribution,
or copying of this communication is strictly prohibited. If you
have received this
communication in error, please delete the original message.
Thank you.
_______________________________________________________________________________________
Hello Howard: Thanks for your prompt response A colleague at U
Wisc, Professor Hutson, alerted me to your company My client, Dr
Sunil Aggarwal of the AIMS clinic in Seattle(whom I cc on this
message), a respected palliative care physician who treats patients with
advanced cancer, seeks psilocybin with which to treat his patients He
of course holds a DEA license to prescribe and administer controlled
substances on Schedule II and beyond He does not hold a Schedule I
license b/c in the ‘normal course’ substances on that Schedule cannot
be prescribed or administered However, Right to Try(RTT) is now the
law of the land, and it does not exclude Schedule I substances from its
ambit(some of the state versions do so, but not the Federal nor the WA
state, where he practices) Hence, it is pursuant to RTT that he seeks
access to this ‘eligible investigational drug’, which psilocybin clearly
is, pursuant to statute
Can we discuss this possibility?
If you have an attorney within the company, or outside counsel, with
whom I could speak, I would be pleased to do so, to discuss the safe
harbor provided by RTT in greater depth
Best,
KT

EMERGE LAW GROUP
Portland, OR 97205
O: 503.227.4525 F: 503.200.1124 D: 206 595.0097
E: kathryn@emergelawgroup com
This communication and any attachments may contain privileged or confidential

information intended for a specific individual and purpose, and is protected by
law If you are not the intended recipient, you should delete this communication
and any attachments, and are notified that any disclosure, copying or distribution
of this communication and any attachments, or the taking of any action based on
it, is strictly prohibited
From: Howard Sard

Date: Thursday, December 3, 2020 at 8:58 AM
SER-13
To: Kathryn Tucker

Cc: Paul Blundell
Hi Kathryn,
Thank you for your inquiry. May I ask how you heard of us?
Under current DEA guidelines, we can ship psilocybin only to a

company or university within the US that holds a DEA Schedule I
license. Once we receive a copy of the DEA license from such an
institution, we can provide further details regarding the purchase of
psilocybin.
Regards,
Howard
Howard Sard, Ph.D
Vice President,
Organix, Inc.
240 Salem Street,
Woburn, MA 01801
781-932-4142
sard@organixinc.com
www.organixinc.com
_______________________________________________________________________________________
This electronic message and any attachment is Organix
Inc. confidential information
intended for the individual or individuals named above.
If the reader is not the
intended recipient, you are hereby notified that any
use, dissemination, distribution,
or copying of this communication is strictly
prohibited. If you have received this
communication in error, please delete the original
message. Thank you.
_______________________________________________________________________________________
Hello Friends at Organix:
I am interested in understanding how one obtains
psilocybin from your company I ask because I am
working with an integrative oncology clinic in Seattle,
whose clinicians seek to access psilocybin for their
seriously ill cancer patients We have not been able to
access psilocybin through Usona, but wonder if you are
able to provide it?
Our work to obtain psilocybin for use in this clinic with
these patients was recently profiled in a Seattle Times
article: https://www seattletimes com/seattle-
news/health/new-legal-push-in-washington-state-aims-to-
speed-magic-mushrooms-to-dying-patients/
If you can supply psilocybin to this clinic we would avoid

need to seek manufacturer registration. Pls advise.
Best,
KT

EMERGE LAW GROUP
Portland, OR 97205
O: 503 227.4525 F: 503.200.1124 D: 206.595 0097
This communication and any attachments may contain privileged

or confidential information intended for a specific individual and
purpose, and is protected by law If you are not the intended
recipient, you should delete this communication and any
attachments, and are notified that any disclosure, copying or
distribution of this communication and any attachments, or the
taking of any action based on it, is strictly prohibited
SER-14

DEA Psilocybin Lawsuit

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DEA Psilocybin Lawsuit

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Case: 21-70544, 06/25/2021, ID: 12155216, DktEntry: 45, Page 1 of 55

IN THE UNITED STATES COURT OF APPEALS

ADVANCED INTEGRATIVE MEDICAL SCIENCE INSTITUTE, PLLC, et al.,

MERRICK B. GARLAND, Attorney General, et al.,

On Petition for Review of a Non-Final Action of the Drug Enforcement

BRIEF FOR RESPONDENTS

STATEMENT OF JURISDICTION ...................................................................................3

STATEMENT OF THE ISSUES..........................................................................................3

PERTINENT STATUTES AND REGULATIONS ........................................................4

STATEMENT OF THE CASE .............................................................................................4

A. Statutory Background ........................................................................................ 4

1. The Controlled Substances Act ........................................................... 4

2. The Federal Food, Drug, and Cosmetic Act ..................................... 7

3. The Right to Try Act ...........................................................................10

B. Factual Background .........................................................................................13

SUMMARY OF ARGUMENT ........................................................................................... 16

STANDARD OF REVIEW ................................................................................................ 18

STATEMENT OF RELATED CASES

Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach,

Hemp Indus. Ass’n v. DEA,

Posadas v. National City Bank,

United States v. 9/1 Kg. Containers,

Agricultural Improvement Act of 2018,

Controlled Substances Act (CSA),

21 U.S.C. § 812(b) .................................................................................................... 5, 13

Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina

5 U.S.C. § 704 ......................................................................................................................... 20

5 U.S.C. § 706(2)(A) .............................................................................................................. 19

21 C.F.R. pt. 312 ............................................................................................................... 8, 25

21 C.F.R. § 1307.03 ............................................................................................................... 34

AIMS Inst., Integrative Oncology, https://www.aimsinstitute.net/services/

Black’s Law Dictionary (11th ed. 2019) ...................................................................................27

DEA, Psilocybin, https://go.usa.gov/x6yRW (last visited June 24, 2021) .................. 1, 13

66 Fed. Reg. 56,607 (Nov. 9, 2001) ...................................................................................... 31

Peter D. Jacobson & Wendy E. Parmet, A New Era of Unapproved Drugs:

treatment. Rather, it permits the distribution of eligible drugs by providing limited

mention controlled substances at all.

Psilocybin is a hallucinogenic substance found in certain mushrooms. See Drug Enf’t

Admin., Psilocybin, https://go.usa.gov/x6yRW (last visited June 24, 2021). When

is unlawful to manufacture, distribute, or possess any drugs in this category, except as

21 U.S.C. §§ 823(f ), 841(a)(1), 844(a)). This is so regardless of whether a state law

The petitioners nevertheless wrote to the Drug Enforcement Administration

have sought judicial review of the agency’s advice.

to psilocybin under any circumstances or under any conceivable agency authority.

neither contrary to law nor arbitrary and capricious.

STATEMENT OF THE ISSUES

threatening conditions. The petitioners wish to use psilocybin—a hallucinogenic

substance found in certain mushrooms—for the treatment of depression and anxiety

in cancer patients. Congress placed psilocybin on Schedule I of the Controlled

1. Whether DEA’s response letter is a final agency action subject to judicial

review under 21 U.S.C. § 877.

and capricious or contrary to law.

PERTINENT STATUTES AND REGULATIONS

STATEMENT OF THE CASE

1. The Controlled Substances Act

The Controlled Substances Act (CSA), 21 U.S.C. § 801 et seq., establishes a

substances. The law makes it unlawful to “manufacture, distribute, or dispense, or

possess with intent to manufacture, distribute, or dispense” any controlled substance,