April 26, 2017 G.R. No.

217872 Prohibition, Mandamus with Prayer for Issuance of a Temporary

Restraining Order and/or Writ of Preliminary Prohibitory and
ALLIANCE FOR THE FAMILY FOUNDATION, PHILIPPINES, INC. Mandatory Injunction (G.R. No. 217872); and the [2] Petition for
(ALFI) and ATTY. MARIA CONCEPCION S. NOCHE, in her own Contempt of Court (G.R. No. 221866), in the following manner:
behalf and as President of ALFI, JOSE S. SANDEJAS, ROSIE B.
LUISTRO, ELENITA S.A. SANDEJAS, EMILY R. LAWS, EILEEN Z. WHEREFORE, the case docketed as G.R No. 217872 is hereby
ARANETA, SALV ACION C. MONTEIRO, MARIETTA C. GORREZ, REMANDED to the Food and Drugs Administration which is hereby
ROLANDO M. BAUTISTA, RUBEN T. UMALI, and MILDRED C. ordered to observe the basic requirements of due process by
CASTOR , Petitioners vs. conducting a hearing, and allowing the petitioners to be heard, on the
HON. JANETTE L. GARIN, Secretary-Designate of the re-certified, procured and administered contraceptive drugs and
Department of Health; NICOLAS B.LUTERO III, Assistant devices, including Implanon and lmplanon NXT, and to determine
Secretary of Health, Officer-in-Charge, Food and Drug whether they are abortifacients or non-abortifacients.
Administration; and MARIA LOURDES C. SANTIAGO, Officer in-
Charge, Center for Drug Regulation and Research, Respondents Pursuant to the expanded jurisdiction of this Court and its power to
issue rules for the protection and enforcement of constitutional rights,
x-----------------------x the Court hereby:

G.R. No. 221866 1. DIRECTS the Food and Drug Administration to formulate the rules
of procedure in the screening, evaluation and approval of all
MARIA CONCEPCION S. NOCHE, in her own behalf and as contraceptive drugs and devices that will be used under Republic Act
counsel of Petitioners, JOSE S. SANDEJAS, ROSIE B. LUISTRO, No. 10354. The rules of procedure shall contain the following
ELENITA S.A. SANDEJAS, EMILY R. LAWS EILEEN Z. minimum requirements of due process: (a) publication, notice and
ARANETA, SALVACION C. MONTEIRO MARIETTA C. GORREZ, hearing, (b) interested parties shall be allowed to intervene, (c) the
ROLANDO M. BAUTISTA, RUBEN T. UMALI, and MILDRED C. standard laid down in the Constitution, as adopted under Republic
CASTOR, Petitioners vs. Act No. 10354, as to what constitutes allowable contraceptives shall
HON. JANETTE L. GARIN, Secretary-Designate of the be strictly followed, that is, those which do not harm or destroy the
Department of Health; NICOLAS B. LUTERO III, Assistant life of the unborn from conception/fertilization, (d) in weighing the
Secretary of Health; NICOLAS B. LUTERO III, Assistant evidence, all reasonable doubts shall be resolved in favor of the
Secretary of Health, Officer-in-Charge, Food and Drug protection and preservation of the right to life of the unborn from
Administration; and MARIA LOURDES C. SANTIAGO, Officer-in- conception/fertilization, and (e) the other requirements of
Charge, Center for Drug Regulation and Research, Respondents. administrative due process, as summarized in Ang Tibay v.
CIR,  shall be complied with.
Subject of this resolution is the Omnibus Motion1 filed by the
respondents, thru the Office of the Solicitor General (OSG), seeking 2. DIRECTS the Department of Health in coordination with other
partial reconsideration of the August 24, 2016 Decision concerned agencies to formulate the rules and regulations or
(Decision),2 where the Court resolved the: [1] Petition for Certiorari, guidelines which will govern the purchase and distribution/

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dispensation of the products or supplies under Section 9 of Republic Arguments of the Respondents
Act No. 10354 covered by the certification from the Food and Drug
Administration that said product and supply is made available on the Part 1: Due Process need not be
condition that it will not be used as an abortifacient subject to the complied with as the questioned
following minimum due process requirements: (a) publication, notice acts of the Food and Drug
and hearing, and (b) interested parties shall be allowed to intervene. Administration (FDA) were in
The rules and regulations or guidelines shall provide sufficient detail the exercise of its Regulatory Powers
as to the manner by which said product and supply shall be strictly
In the subject Omnibus Motion, the respondents argued that their
regulated in order that they will not be used as an abortifacient and in
actions should be sustained, even if the petitioners were not afforded
order to sufficiently safeguard the right to life of the unborn.
notice and hearing, because the contested acts of registering, re-
3. DIRECTS the Department of Health to generate the complete and certifying, procuring, and administering contraceptive drugs and
correct list of the government's reproductive health programs and devices were all done in the exercise of its regulatory power.4 They
services under Republic Act No. 10354 which will serve as the contended that considering that the issuance of the certificate of
template for the complete and correct information standard and, product registration (CPR) by the FDA under Section 7.04, Rule5 of
hence, the duty to inform under Section 23(a)(l) of Republic Act No. the Implementing Rules and Regulations of Republic Act (R.A.) No.
10354. The Department of Health is DIRECTED to distribute copies 10354 (RH-IRR) did not involve the adjudication of the parties'
of this template to all health care service providers covered by opposing rights and liabilities through an adversarial proceeding, the
Republic Act No. 10354. due process requirements of notice and hearing need not be
complied with.6
The respondents are hereby also ordered to amend the
Implementing Rules and Regulations to conform to the rulings and Stated differently, the respondents assert that as long as the act of
guidelines in G.R. No. 204819 and related cases. the FDA is exercised pursuant to its regulatory power, it need not
comply with the due process requirements of notice and hearing.
The above foregoing directives notwithstanding, within 30 days from
receipt of this disposition, the Food and Drugs Administration should Corollary to this, the respondents wanted the Court to consider that
commence to conduct the necessary hearing guided by the cardinal the FDA had delineated its functions among different persons and
rights of the parties laid down in CIR v. Ang Tibay. bodies in its organization. Thus, they asked the Court to make a
distinction between the "quasi-judicial powers" exercised by
Pending the resolution of the controversy, the motion to lift the the Director-General of the FDA under Section 2(b)7 of Article 3,
Temporary Restraining Order is DENIED. Book I of the Implementing Rules and Regulations (IRR) of R.A. No.
9711,8 and the "regulatory/administrative powers" exercised
With respect to the contempt petition, docketed as G.R No. 221866, by the FDA under Section 2(c )(1) 9 of the same. For the
it is hereby DENIED for lack of concrete basis. respondents, the distinction given in the above-cited provisions was
all but proof that the issuance of CPR did not require notice and
SO ORDERED.3
hearing.

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After detailing the process by which the FDA's Center for Drug The Court's Ruling
Regulation and Research (CDRR) examined and tested the
contraceptives for non-abortifacience, 10 the respondents stressed After an assiduous assessment of the arguments of the parties, the
that the Decision wreaked havoc on the organizational structure of Court denies the Omnibus Motion, but deems that a clarification on
the FDA, whose myriad of functions had been carefully delineated in some points is in order.
the IRR of R.A. No. 9711. 11 The respondents, thus, prayed for the
Judicial Review
lifting of the Temporary Restraining Order (TR0).  12
The powers of an administrative body are classified into two
Part 2: The requirements of due
fundamental powers: quasi-legislative and quasi-judicial.  Quasi-
process need not be complied with as
legislative power, otherwise known as the power of subordinate
the elements of procedural due
legislation, has been defined as the authority delegated by the
process laid down in Ang Tibay v.
lawmaking body to the administrative body to adopt rules and
CIR are not applicable
regulations intended to carry out the provisions of law and implement
The respondents further claimed in their omnibus motion that the legislative policy. 18 "[A] legislative rule is in the nature of subordinate
requirements of due process need not be complied with because the legislation, designed to implement a primary legislation by providing
standards of procedural due process laid down in Ang Tibay v. the details thereof." 19 The exercise by the administrative body of its
CIR  13 were inapplicable considering that: a) substantial evidence quasi-legislative power through the promulgation of regulations of
could not be used as a measure in determining whether a general application does not, as a rule, require notice and hearing.
contraceptive drug or device was abortifacient; 14 b) the courts had The only exception being where the Legislature itself requires it and
neither jurisdiction nor competence to review the findings of the FDA mandates that the regulation shall be based on certain facts as
on the non-abortifacient character of contraceptive drugs or determined at an appropriate investigation.20
devices; 15 c) the FDA was not bound by the rules of admissibility and
Quasi-judicial power, on the other hand, is known as the power of
presentation of evidence under the Rules of Court; 16 and d) the
the administrative agency to determine questions of fact to which the
findings of the FDA could not be subject of the rule on res
legislative policy is to apply, in accordance with the standards laid
judicata and stare-decisis.  17
down by the law itself.21 As it involves the exercise of discretion in
The respondents then insisted that Implanon and Implanon NXT determining the rights and liabilities of the parties, the proper
were not abortifacients and lamented that the continued injunction of exercise of quasi-judicial power requires the concurrence of two
the Court had hampered the efforts of the FDA to provide for the elements: one,  jurisdiction which must be acquired by the
reproductive health needs of Filipino women. For the respondents, to administrative body and two, the observance of the requirements
require them to afford the parties like the petitioners an opportunity to of due process, that is, the right to notice and hearing.22
question their findings would cause inordinate delay in the
On the argument that the certification proceedings were conducted
distribution of the subject contraceptive drugs and devices which
by the FDA in the exercise of its "regulatory powers" and, therefore,
would have a dire impact on the effective implementation of the RH
beyond judicial review, the Court holds that it has the power to
Law.

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review all acts and decisions where there is a commission of grave occupation, like the operation of a liquor store or restaurant. x x
abuse of discretion. No less than the Constitution decrees that the x. 23 [Emphases and underscoring supplied]
Court must exercise its duty to ensure that no grave abuse of
discretion amounting to lack or excess of jurisdiction is committed by From the above, two things are apparent: one, the "enabling powers"
any branch or instrumentality of the Government. Such is committed cover "regulatory powers" as defined by the respondents; and two,
when there is a violation of the constitutional mandate that "no they refer to a subcategory of a quasi-judicial power which, as
person is deprived of life, liberty, and property without due process of explained in the Decision, requires the compliance with the twin
law." The Court's power cannot be curtailed by the FDA's invocation requirements of notice and hearing. Nowhere from the above-quoted
of its regulatory power. texts can it be inferred that the exercise of "regulatory power" places
an administrative agency beyond the reach of judicial review. When
In so arguing, the respondents cited Atty. Carlo L. Cruz in his there is grave abuse of discretion, such as denying a party of his
book, Philippine Administrative Law. constitutional right to due process, the Court can come in and
exercise its power of judicial review. It can review the challenged
Lest there be any inaccuracy, the relevant portions of the book cited acts, whether exercised by the FDA in its ministerial, quasi-judicial or
by the respondents are hereby quoted as follows: regulatory power. In the past, the Court exercised its power of judicial
review over acts and decisions of agencies exercising their
xxx.
regulatory powers, such as DPWH, 24 TRB, 25 NEA, 26 and the
B. The Quasi-Judicial Power SEC,27 among others. In Diocese of Bacolod v. Commission on
Elections,28 the Court properly exercised its power of judicial review
xxx over a Comelec resolution issued in the exercise of its regulatory
power.
2. Determinative Powers
Clearly, the argument of the FDA is flawed.
To better enable the administrative body to exercise its quasi
judicial authority, it is also vested with what is known Petitioners were Denied their
as determinative powers and functions. Right to Due Process

Professor Freund classifies them generally into the enabling  powers Due process of law has two aspects: substantive and procedural. In
and the directing powers. The latter includes order that a particular act may not be impugned as violative of the
the dispensing,  the examining,  and the summary  powers. due process clause, there must be compliance with both the
substantive and the procedural requirements thereof. 29 Substantive
The enabling vowers  are those that permit the doing of an act due process refers to the intrinsic validity of a law that interferes with
which the law undertakes to regulate  and which would be the rights of a person to his property.30 Procedural due process, on
unlawful with government approval. The most common example the other hand, means compliance with the procedures or steps,
is the issuance of licenses to engage in a particular business or even periods, prescribed by the statute, in conformity with the

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standard of fair play and without arbitrariness on the part of those The law and the rules demand
who are called upon to administer it.31 compliance with due process
requirements
The undisputed fact is that the petitioners were deprived of their
constitutional right to due process of law. A reading of the various provisions, cited by the respondents in
support of their assertion that due process need not be complied with
As expounded by the Court, what it found to be primarily deplorable in the approval of contraceptive drugs or devices, all the more
is the failure of the respondents to act upon, much less address, the reinforces the Court's conclusion that the FDA did fail to afford the
various oppositions filed by the petitioners against the product petitioners a genuine opportunity to be heard.
registration, recertification, procurement, and distribution of the
questioned contraceptive drugs and devices. Instead of addressing As outlined by the respondents themselves, the steps by which the
the petitioners' assertion that the questioned contraceptive drugs and FDA approves contraceptive drugs or devices, demand compliance
devices fell within the definition of an "abortifacient" under Section with the requirements of due process viz:
4(a) of the RH Law because of their "secondary mechanism of action
which induces abortion or destruction of the fetus inside the mother's Step 1. Identify contraceptive products in the database. Create
womb or the prevention of the fertilized ovum to reach and be another database containing the following details of contraceptive
implanted in the mother's womb,"32 the respondents chose to ignore products: generic name, dosage strength and form, brand name (if
them and proceeded with the registration, recertification, any), registration number, manufacturer, MAH, and the period of
procurement, and distribution of several contraceptive drugs and validity of the CPR.
devices.
Step 2. Identify contraceptive products which are classified as
A cursory reading of the subject Omnibus Motion shows that the essential medicines in the Philippine Drug Formulary.
respondents proffer no cogent explanation as to why they did not act
Step 3. Retrieve the contraceptive product's file and the CPR
on the petitioners' opposition. As stated by the Court in the Decision,
duplicate of all registered contraceptive products. Create a database
rather than provide concrete action to meet the petitioners'
of the contraceptive product's history, including its initial, renewal,
opposition, the respondents simply relied on their challenge
amendment, and/or variation applications.
questioning the propriety of the subject petition on technical and
procedural grounds. 33 The Court, thus, finds the subject motion to be Step 4. Conduct a preliminary review of the following:
simply a rehash of the earlier arguments presented before, with the
respondents still harping on the peculiarity of the FDA's functions to a. general physiology of female reproductive system, including
exempt it from compliance with the constitutional mandate that "no hormones involved, female reproductive cycle, and conditions of the
person shall be deprived oflife, liberty and property without due female reproductive system during pregnancy.
process of law."
b. classification of hormonal contraceptives;

c. regulatory status of the products in benchmark countries; and

Page 5 of 12
d. mechanism of action of hormonal contraceptives based on The Court notes that the above-outlined procedure is deficient
reputable journals, meta-analyses, systemic reviews, evaluation of insofar as it only allows public comments to cases of re-
regulatory authorities in other countries, textbooks, among others. certification. It fails to allow the public to comment in cases where a
reproductive drug or device is being subject to the certification
Step 5. Issue a notice to all concerned MAHs, requiring them to process for the first time. This is clearly in contravention of the
submit scientific evidence that their product is non- mandate of the Court in lmbong  that the IRR should be
abortifacient, as defined in the RH Law and Imbong. amended to conform to it.

Step 6. Post a list of contraceptive products which were applied More importantly, the Court notes that Step 5 requires the FDA to
for re-certification for public comments in the FDA website. issue a notice to all concerned MAHs and require them to submit
scientific evidence that their product is non-abortifacient; and that
Step 7. Evaluate contraceptive products for re-certification.
Step 6 requires the posting of the list of contraceptive products which
A. Part I (Review of Chemistry, Manufacture and Controls) were applied for re-certification for public comments in the FDA
website.
1. Unit Dose and Finished Product Formulation
If an opposition or adverse comment is filed on the ground that
2. Technical Finished Product Specifications the drug or devise has abortifacient features or violative of the
RH Law, based on the pronouncements of the Court in Im bong  or
3. Certificate of Analysis any other law or rule, the FDA is duty-bound to take into account and
consider the basis of the opposition.
B. Part II (Evaluation of Whether the Contraceptive Product is
Abortifacient) To conclude that product registration, recertification, procurement,
and distribution of the questioned contraceptive drugs and devices
1. Evaluation of the scientific evidence submitted by the applicant
by the FDA in the exercise of its regulatory power need not comply
and the public.
with the requirements of due process would render the issuance of
2. Review and evaluation of extraneous evidence, e.g., scientific notices to concerned MAHs and the posting of a list of contraceptives
journals, meta-analyses, etc. for public comment a meaningless exercise. Concerned MAHs and
the public in general will be deprived of any significant participation if
Step 8. Assess and review the documentary requirements submitted what they will submit will not be considered.
by the applicant. Technical reviewers considered scientific evidence
such as meta-analyses, systemic reviews, national and clinical Section 7.04, Rule 7 of the IRR of the RH Law (RH-IRR),35 relied
practice guidelines and recommendations of international medical upon by the respondents in support of their claims, expressly allows
organizations submitted by the companies, organizations and the consideration of conflicting evidence, such as that supplied
individuals, to be part of the review.34 [Emphases and Underlining by the petitioners in support of their opposition to the approval of
supplied] certain contraceptive drugs and devices. In fact, the said provision
mandates that the FDA utilize the "best evidence available" to ensure

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that no bortifacient is approved as a family planning drug or device. It be under the Office of the Secretary and shall have the following
bears mentioning that the same provision even allows an functions, powers and duties:
independent evidence review group (ERG) to ensure that evidence
for or against the certification of a contraceptive drug or device is "(a) To administer the effective implementation of this Act and of the
duly considered. rules and regulations issued pursuant to the same;

Structure of the FDA "(b) To assume primary jurisdiction in the collection of samples of
health products;
As earlier mentioned, the respondents argue that the Decision
"wreaked havoc on the organizational structure of the FDA, whose "(c) To analyze and inspect health products in connection with the
myriad of functions have been carefully delineated under R.A. No. implementation of this Act;
9711 IRR."36 Citing Section 7.04, Rule 7 of the RH-IRR, the FDA
"(d) To establish analytical data to serve as basis for the preparation
insists that the function it exercises in certifying family planning
of health products standards, and to recommend standards of
supplies is in the exercise of its regulatory power, which cannot be
identity, purity, safety, efficacy, quality and fill of container;
the subject of judicial review, and that it is the Director-General of
the FDA who exercises quasi-judicial powers, citing Section 2(b) of "(e) To issue certificates of compliance with technical requirements
Article 3, Book I of the RH-IRR.37 to serve as basis for the issuance of appropriate authorization and
spot-check for compliance with regulations regarding operation of
The FDA wants the Court to consider that, as a body, it has a distinct
manufacturers, importers, exporters, distributors, wholesalers, drug
and separate personality from the Director-General, who exercises
outlets, and other establishments and facilities of health products, as
quasi-judicial power. The Court cannot accommodate the position of
determined by the FDA;
the respondents. Section 6(a) of R.A. No. 3720, as amended by
Section 7 of R.A. No. 9711,38 provides that "(a) The FDA shall be "xxx
headed by a director-general with the rank of undersecretary,
xxx." How can the head be separated from the body? "(h) To conduct appropriate tests on all applicable health products
prior to the issuance of appropriate authorizations to ensure safety,
For the record, Section 4 of R.A. No. 3720, as amended by Section 5 efficacy, purity, and quality;
of R.A. No. 9711, also recognizes compliance with the requirements
of due process, although the proceedings are not adversarial. Thus: "(i) To require all manufacturers, traders, distributors, importers,
exporters, wholesalers, retailers, consumers, and non-consumer
Section 5. Section 4 of Republic Act No. 3720, as amended, is users of health products to report to the FDA any incident that
hereby further amended to read as follows: reasonably indicates that said product has caused or contributed to
the death, serious illness or serious injury to a consumer, a patient,
"SEC. 4. To carry out the provisions of this Act, there is hereby
or any person;
created an office to be called the Food and Drug Administration
(FDA) in the Department of Health (DOH). Said Administration shall

Page 7 of 12
"G) To issue cease and desist orders motu propio or upon verified The Cardinal Rights of Parties in
com plaint for health products, whether or not registered with the Administrative Proceedings as
FDA Provided, That for registered health products, the cease and laid down in Ang Tibay v. CIR
desist order is valid for thirty (30) days and may be extended for sixty
(60) days only after due process has been observed; In Ang Tibay v. CJR,39 the Court laid down the cardinal rights of
parties in administrative proceedings, as follows:
"(k) After due process, to order the ban, recall, and/or withdrawal of
any health product found to have caused the death, serious illness or 1) The right to a hearing, which includes the right to present one's
serious injury to a consumer or patient, or is found to be imminently case and submit evidence in support thereof;
injurious, unsafe, dangerous, or grossly deceptive, and to require all
2) The tribunal must consider the evidence presented;
concerned to implement the risk management plan which is a
requirement for the issuance of the appropriate authorization; 3) The decision must have something to support itself;
"(l) To strengthen the post market surveillance system in monitoring 4) The evidence must be substantial;
health products as defined in this Act and incidents of adverse
events involving such products; 5) The decision must be rendered on the evidence presented at the
hearing, or at least contained in the record and disclosed to the
"(m) To develop and issue standards and appropriate authorizations parties affected;
that would cover establishments, facilities and health products;
6) The tribunal or body or any of its judges must act on its or his own
"(n) To conduct, supervise, monitor and audit research studies on independent consideration of the law and facts of the controversy
health and safety issues of health products undertaken by entities and not simply accept the views of a subordinate in arriving at a
duly approved by the FDA; decision; and
"(o) To prescribe standards, guidelines, and regulations with respect 7) The board or body should, in all controversial questions, render its
to information, advertisements and other marketing instruments and decision in such a manner that the parties to the proceeding can
promotion, sponsorship, and other marketing activities about the know the various issues involved, and the reason for the decision
health products as covered in this Act; rendered. 40
"(p) To maintain bonded warehouses and/or establish the same, In the Decision, the Court found that the FDA certified, procured and
whenever necessary or appropriate, as determined by the director- administered contraceptive drugs and devices, without the
general for confiscated goods in strategic areas of the country observance of the basic tenets of due process, that is, without notice
especially at major ports of entry; and and without public hearing. It appeared that, other than the notice
inviting stakeholders to apply for certification/recertification of their
"(q) To exercise such other powers and perform such other functions
reproductive health products, there was no showing that the
as may be necessary to carry out its duties and responsibilities under
this Act. [Emphases supplied]

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respondents considered the opposition of the petitioners. Thus, the apparent, a decision rendered in disregard of that right is void for
Court wrote: lack of jurisdiction. This rule is equally true in quasi-judicial and
administrative proceedings, for the constitutional guarantee that no
Rather than provide concrete evidence to meet the petitioners' man shall be deprived of life, liberty, or property without due process
opposition, the respondents simply relied on their challenge is unqualified by the type of proceedings (whether judicial or
questioning the propriety of the subject petition on technical and administrative) where he stands to lose the same.41
procedural grounds. The Court notes that even the letters submitted
by the petitioners to the FDA and the DOH seeking information on The Court stands by that finding and, accordingly, reiterates its order
the actions taken by the agencies regarding their opposition were left of remand of the case to the FDA.
unanswered as if they did not exist at all. The mere fact that the RH
Law was declared as not unconstitutional does not permit the Procedure in the FDA; No Trial-Type Hearing
respondents to run roughshod over the constitutional rights,
The Court is of the view that the FDA need not conduct a trial-type
substantive and procedural, of the petitioners.
hearing. Indeed, due process does not require the conduct of a trial-
Indeed, although the law tasks the FDA as the primary agency to type hearing to satisfy its requirements. All that the Constitution
determine whether a contraceptive drug or certain device has no requires is that the FDA afford the people their right to due process
abortifacient effects, its findings and conclusion should be allowed to of law and decide on the applications submitted by MAHs after
be questioned and those who oppose the same must be given a affording the oppositors like the petitioners a genuine opportunity to
genuine opportunity to be heard in their stance. After all, under present their science-based evidence. As earlier pointed out, this the
Section 4(k) of R.A. No. 3720, as amended by R.A. No. 9711, the FDA failed to do. It simply ignored the opposition of the petitioners. In
FDA is mandated to order the ban, recall and/ or withdrawal of any the case of Perez, et al. v. Philippine Telegraph and Telephone
health product found to have caused death, serious illness or serious Company, et al.,  42 it was stated that:
injury to a consumer or patient, or found to be imminently injurious,
A formal trial-type hearing is not even essential to due process. It is
unsafe, dangerous, or grossly deceptive, after due process.
enough that the parties are given a fair and reasonable opportunity to
Due to the failure of the respondents to observe and comply with the explain their respective sides of the controversy and to present
basic requirements of due process, the Court is of the view that the supporting evidence on which a fair decision can be based.
certifications/re-certifications and the distribution of the questioned
In the fairly recent case of Vivo v. Pagcor,43 the Court explained:
contraceptive drugs by the respondents should be struck down as
violative of the constitutional right to due process. The observance of fairness in the conduct of any investigation is at
the very heart of procedural due process. The essence of due
Verily, it is a cardinal precept that where there is a violation of basic
process is to be heard, and, as applied to administrative
constitutional rights, the courts are ousted from their jurisdiction. The
proceedings, this means a fair and reasonable opportunity to explain
violation of a party's right to due process raises a serious
one's side, or an opportunity to seek a reconsideration of the action
jurisdictional issue which cannot be glossed over or disregarded at
or ruling complained of. Administrative due process cannot be
will. Where the denial of the fundamental right to due process is
fully equated with due process in its strict judicial sense, for in

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the former a formal or trial-type hearing is not always experts known in their fields. It is also not bound by the principle
necessary, and technical rules of procedure are not strictly of stare decisis  or res judicata, but may update itself and cancel
applied. Ledesma v. Court of Appeals  elaborates on the well- certifications motu proprio  when new contrary scientific findings
established meaning of due process in administrative proceedings in become available or there arise manifest risks which have not been
this wise: earlier predicted.

x x x Due process, as a constitutional precept, does not always and On the Competence of the Court
in all situations require a trial-type proceeding. Due process is to review the Findings of the FDA
satisfied when a person is notified of the charge against him and
given an opportunity to explain or defend himself. In administrative The fact that any appeal to the courts will involve scientific matters
proceedings, the filing of charges and giving reasonable opportunity will neither place the actions of the respondents beyond the need to
for the person so charged to answer the accusations against him comply with the requirements of Ang Tibay nor place the actions of
constitute the minimum requirements of due process. The essence of the FDA in certification proceedings beyond judicial review.
due process is simply to be heard, or as applied to administrative
It should be pointed out that nowhere in Batas Pambansa Blg. 129,
proceedings, an opportunity to explain one's side, or an opportunity
as amended, are the courts ousted of their jurisdiction whenever the
to seek a reconsideration of the action or ruling complained of.
issues involve questions of scientific nature. A court is not
[Emphasis supplied; citations omitted]
considered incompetent either in reviewing the findings of the FDA
Best Evidence Available simply because it will be weighing the scientific evidence presented
by both the FDA and its oppositors in determining whether the
Section 5, Rule 133 of the Rules of Court provides: contraceptive drug or device has complied with the requirements of
the law.
Section 5. In all cases filed before administrative or quasi-
judicialbodies, a fact may be deemed established if it is supported Although the FDA is not strictly bound by the technical rules on
by substantialevidence, or the amount of relevant evidence which a evidence, as stated in the Rules of Court, or it cannot be bound by
reasonable mind might accept as adequate to justify a conclusion. the principle of stare decisis or res judicata,  it is not excused from
complying with the requirements of due process. To reiterate for
As applied to certification proceedings at the FDA, "substantial emphasis, due process does not require that the FDA conduct trial-
evidence" refers to the best scientific evidence type hearing to satisfy its requirements. All that the Constitution
available,44 "including but not limited to: meta analyses, systematic requires is that the FDA afford the people their right to due process
reviews, national clinical practice guidelines where available, and of law and decide on the applications submitted by the MAHs after
recommendations of international medical organizations," needed to affording the oppositors, like the petitioners, a genuine opportunity to
support a conclusion whether a contraceptive drug or device is an present their sciencebased evidence.
abortifacient or not. The FDA need not be bound or limited by the
evidence adduced by the parties, but it can conduct its own search The Appellate Procedure;
for related scientific data. It can also consult other technical scientific Appeal to the Office of the President

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Incidentally, Section 32 of R.A. No. 3720 and Section 9 of Executive planning supplies in accredited public health facilities and the
Order (E.O.)  No. 247 provide that any decision by the FDA would commercial market. "45
then be appealable to the Secretary of Health, whose decision, in
tum, may be appealed to the Office of the President (OP). Thus: On this score, it should be clarified that the Decision simply enjoined
the respondents from registering, recertifying, procuring, and
Sec. 32. The orders, rulings or decisions of the FDA shall be administering only those contraceptive drugs and devices which
appealable to the Secretary of Health. - An appeal shall be were the subjects of the petitioners' opposition, specifically Implanon
deemed perfected upon filing of the notice of appeal and posting of and Implanon NXT. It never meant to enjoin the processing of the
the corresponding appeal bond. entire gamut of family planning supplies that have been declared as
unquestionably non-abortifacient. Moreover, the injunction issued by
An appeal shall not stay the decision appealed from unless an order the Court was only subject to the condition that the respondents
from the Secretary of Health is issued to stay the execution thereof. afford the petitioners a genuine opportunity to their right to due
process.
Sec. 9. Appeals. - Decisions of the Secretary (DENR, DA, DOH or
DOST) may be appealed to the Office of the President. Recourse As the Decision explained, the Court cannot lift the TRO prior to the
to the courts shall be allowed after exhaustion of all administrative summary hearing to be conducted by the FDA. To do so would
remedies. render the summary hearing an exercise in futility. Specifically, the
respondents would want the Court to consider their argument that
In view thereof, the Court should modify that part of the Decision
Implanon and Implanon NXT have no abortifacient effects. According
which allows direct appeal of the FDA decision to the Court of
to them, "the FDA tested these devices for safety, efficacy, purity,
Appeals.1âwphi1 As stated in the said decision, the FDA decision
quality, and non-abortiveness prior to the issuance of certificates of
need not be appealed to the Secretary of Health because she herself
registration and recertification, and after the promulgation of
is a party herein. Considering that the Executive
Imbong." 46 The Court, however, cannot make such
Secretary is not a party herein, the appeal should be to the OP as determination or pronouncement at this time. To grant its prayer
provided in Section 9. to lift the TRO would be premature and presumptuous. Any
declaration by the Court at this time would have no basis because
On the Prayer to Lift the TRO the FDA, which has the mandate and expertise on the matter, has to
first resolve the controversy pending before its office.
The respondents lament that the assailed decision undermines the
functions of the FDA as the specialized agency tasked to determine This Court also explained in the Decision that the issuance of the
whether a contraceptive drug or device is safe, effective and non- TRO did not mean that the FDA should stop fulfilling its mandate to
abortifacient. They also claim that the assailed decision requiring test, analyze, scrutinize, and inspect other drugs and devices. Thus:
notice and hearing would unduly delay the issuance of CPR thereby
affecting public access to State-funded contraceptives. Finally, in a Nothing in this resolution, however, should be construed as
veritable attempt to sow panic, the respondents claim that the TRO restraining or stopping the FDA from carrying on its mandate and
issued by the Court would result in "a nationwide stockout of family duty to test, analyze, scrutinize, and inspect drugs and devices. What

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are being enjoined are the grant of certifications/re-certifications of speedy disposition of their cases before all judicial, quasi-judicial and
contraceptive drugs without affording the petitioners due process, administrative bodies."49
and the distribution and administration of the questioned
contraceptive drugs and devices including Implanon and Implanon WHEREFORE, the August 24, 2016 Decision
NXT until they are determined to be safe and non-abortifacient.47 is MODIFIED. Accordingly, the Food and Drug Administration is
ordered to consider the oppositions filed by the petitioners with
On Delay respect to the listed drugs, including Implanon and Implanon NXT,
based on the standards of the Reproductive Health Law, as
The respondents claim that this judicial review of the administrative construed in lmbong v. Ochoa,  and to decide the case within sixty
decision of the FDA in certifying and recertifying drugs has caused (60) days from the date it will be deemed submitted for resolution.
much delay in the distribution of the subject drugs with a dire impact
on the effective implementation of the RH Law. After compliance with due process and upon promulgation of the
decision of the Food and Drug Administration, the Temporary
In this regard, the respondents have only themselves to blame. Restraining Order would be deemed lifted if the questioned drugs
Instead of complying with the orders of the Court as stated in the and devices are found not abortifacients.
Decision to conduct a summary hearing, the respondents have
returned to this Court, asking the Court to reconsider the said After the final resolution by the Food and Drug Administration, any
decision claiming that it has wreaked havoc on the organizational appeal should be to the Office of the President pursuant to Section 9
structure of the FDA. of E.O. No. 247.

Had the FDA immediately conducted a summary hearing, by this As ordered in the August 24, 2016 Decision, the Food and Drug
time it would have finished it and resolved the opposition of the Administration is directed to amend the Implementing Rules and
petitioners.1âwphi1 Note that there was already a finding by the Regulations of R.A. No. 10354 so that it would be strictly compliant
FDA, which was its basis in registering, certifying and recertifying the with the mandates of the Court in lmbong v. Ochoa.
questioned drugs and devices. The pharmaceutical companies or the
MAHs need not present the same evidence it earlier adduced to SO ORDERED.
convince the FDA unless they want to present additional evidence to
fortify their positions. The only entities that would present evidence
would be the petitioners to make their point by proving with relevant
scientific evidence that the contraceptives have abortifacient effects.
Thereafter, the FDA can resolve the controversy.

Indeed, in addition to guaranteeing that no person shall be deprived

of life, liberty and property without due process of law,48 the
Constitution commands that "all persons shall have the right to a

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