http://www.inpharm.

com/news/153270/digital-pharma-pmcpa-digital-communications-guidelines

The UKs Code of Practice regulator has issued guidance on social media and other digital communications tools. It is the first time an industry regulator has addressed the area so directly and comes ahead of US guidelines from the FDA, which have once-again been delayed. But rather than formulate new rules for tools like Twitter the PMCPA has instead put together a Q&A document to explain how digital communication fits into its existing regulations. It took this step, rather than amend UK pharmas self-regulatory Code, because there have been few complaints about digital communication. It also makes good on a pledge it made last year. The Q&A document explains the place of digital communication tools within the existing rules, which ultimately comes down to companies can use digital media if they stick to the Code. It also adds particular emphasis on the Codes existing ban on promoting prescription-only medicines to the public. Therefore, pharmaceutical companies need to identify ways of utilising digital communications whilst complying with this restriction. Companies can use any method of communicating to any audience provided relevant requirements of the Code are followed, the PMCPA said. This has always been the case at least for companies looking to innovate and the last couple of years have seen a number of examples of digital communications being used by UK pharma. These include Janssens Facebook psoriasis page, Pfizers use of Twitter, Flickr and Facebook for a chronic pain awareness campaign and GlaxoSmithKlines patient information website. The Code and digital communications The Code of Practice applies to the promotion of medicines to healthcare professionals and to the provision of information about prescription-only medicines to the general public. It covers any kind of communication from sales rep visits to doctors to public awareness campaigns. The PMCPAsnew Q&A document covers the use of Twitter, blogs, meta data in search engine optimisation, online meetings and linking to non-company websites. It introduces to the Code a limited new use for [providing] reference information a proactive use rather than a reactive use.

This is in the context of allowing a company to refer Wikipedia readers to its own information about a medicine via a link to an appropriate landing page. The document also notes that digital communication is a developing area and counsels pharma to bear in mind not just the letter of the Code but also the spirit in which it is intended. Some notable questions and answers in the document include: Can pharma use social media to communicate with healthcare professionals? This is very likely to be seen as promotion under the Code if it covers prescription-only medicines. This would be allowed on social media, as it is in a face-to-face meeting with a sales rep, but companies would have to ensure only healthcare professionals could see the communications and the recipients would need to have agreed to receive the information. Singling out Twitter for special attention the PMCPA said: Given these restrictions and the character limit on Twitter, it is highly unlikely that the use of this medium to promote prescription-only medicines would meet the requirement of the Code. It also notes that using Twitter to alert healthcare professionals about the publication of a study on a medicine is likely to be considered promotion of that medicines. Can pharma use social media to provide information to the public? Yes, providing the material complies with the Code particularly Clause 22. Clause 22 of the Code deals with relations with the public and the media and includes bars on advertising prescription medicines to the public and responding to individuals requests for with medical advice.
For this reason, the FDA social media regulations for pharma marketing are extremely strict, and at the same time still somewhat ambiguous, lacking clear structural boundaries that are needed to prevent unwarranted issues. Unfortunately, this puts the FDA on a collision course with the pharmaceutical companies. http://www.pharmaphorum.com/2012/07/09/social-media-challenges-benefits-pharmaceuticalcompanies/ In late December 2011, the FDA issued the guidance "Responding to Unsolicited Requests for Off-Label Information about Prescription Drugs and Medical Devices." The guidance addresses a targeted topic within consumer/Pharma communication, but with direct application to social media communications.

In summary: - The guidance does not change or otherwise effect existing regulations. Rather, it offers more information on interpreting existing regulation.

- Called in the media draft social media guidance, this particular guidance does little to address overall social media use by pharmaceutical and medical device companies and consumers. It does recommend how social media should be used in an off-label context, but the recommendations follow existing regulation that companies in the industry already zealously follow. - Pharmaceutical and medical device companies already have systems and pathways in place for requests for information of off-label uses of approved products. The guidance suggests that requests that come from social media should follow existing pathways as long as they comply with federal regulations. - In regards to any company communication about off-label uses for approved products, the industry must continue to remain vigilant and avoid even the accidental appearance of promotion. This tenant has not changed from existing regulation. - The guidance makes clear that a company may choose to respond to an unsolicited request for off-label use information, but is not required to respond. This distinction adds welcome clarity to the "policing the Internet" issue brought up in the 2009 hearings and gives the company leeway to intervene in a limited way with a potential spread of misinformation. - If a company chooses to respond and does so in a way that honors the guidance, the FDA states that it will not use the response as evidence of the companys intent that the product be used for an unapproved or uncleared use.
http://socialmediatoday.com/emoderation/431738/fda-guidance-pharma-social-media-and-label-use While marketers in the West may face the challenge of pharmaceutical regulation, in China it is also the providers of social media platforms who are heavily regulated. In December 2011, for example, authorities in Beijing issued rules making the registering of users real names on social media platforms compulsory. While Sina Weibo says that it has yet to fully implement this rule, content on social media sites is already censored, with posts about certain topics disappearing from view, according to a study reported in New Scientist.

http://www.pharmaphorum.com/2012/06/25/pharma-gets-social-china-pharmas-social-media-frontier/
April 2011 | In Healthcare | Comments 0

UK first to get Pharma Social Media Guidance

self-regulation rules. The PMCPA is the first regulator to speak directly about online communications for pharmaceuticals. The well anticipated FDAs (US Food and Drug Administration) guide has been delayed yet again for the second time in four months leaving a swarm of pharmaceutical companies in Online Limbo, despite the fact that they issued a statement saying Policy and guidance development for promotion of FDA-regulated medical products using the Internet and social media tools are among our highest priorities, Despite our limited resources and increasing workload (Pharamalot, 2011). In fact, rumours have begun to circulate that they report wont be published until 2013. With the online world moving a lightening speed, the usefulness of this FDA document seems to be is depreciating in value by the day. Rather than issuing a complex set of procedures, The PMCPA have decided to issue a Q+A document about how online communications fits into the current UK regulation, reasoning that they havent had many complaints about digital communications so it should suffice. The Q+A deals with the idea of Twitter and Wikipedia in particular- For example, there is a question relating to whether companys could change incorrect or misleading information on certain websites such as Wikipedia.
http://www.combinedmedia.ie/health/blog/uk-first-to-get-pharma-social-media-guidance http://www.combinedmedia.ie/images/uploads/file/blog/PMCPA_SM_Guidelies_2011.pdf?bcsi_scan_d ebb0e326e6a7dd8=0&bcsi_scan_filename=PMCPA_SM_Guidelies_2011.pdf

We applaud MA for taking this brave step towards advocating the responsible use of social media forums and the development of third party sponsored social media portals, by providing clear and concise guidance on its use and appropriate monitoring. Medicines Australia has expanded its code-of-conduct to incorporate clearly defined guidelines for social media promotions. They have advocated owning responsibility of claims and careful usage of language to represent their idea. Although development of third-party sponsored social media portals is encouraged, the promotion of prescription medicines is clearly restricted. http://www.webershandwick.com.au/revealed-revised-medicines-australia-guidelines/

Sweden does not have a definite plan on regulation of social media as a platform for pharmaceutical companies to connect with patients or HCPs. It proposes ethical values to be followed by the industry in this area. This states that if a pharmaceutical company puts forth an idea, it will become responsible for it. Prescription drugs cannot be advertised, and information about it can be conveyed by HCP only in case of direct contact with patient. These policies promote frequent monitoring of the content for Pharmaceutical companies.