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Food Drug Administration (FDA) Issues Draft Guidance on Use of Social Media in Pharmaceutical Promotion (with Implications for Devices)

he FDA recently issued a draft Guidance document addressing issues arising out of the use of various forms of social media in the promotion of pharmaceuticals. The draft Guidance is a welcome step given the uncertainty surrounding the issues, which has caused many pharmaceutical companies to shy away from social media. The draft Guidance still leaves many questions unanswered, however, and the FDA has stated that it plans to issue more Guidance documents in the future addressing other issues related to the use of social media.

As background, the FDA Safety and Innovation Act, passed in the summer of 2012, required FDA to “issue guidance that describes FDA policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by the FDA.” RAPS’ Regulatory Focus Today reports that FDA deems this Guidance to satisfy that statutory requirement (despite its somewhat narrow focus).

The draft Guidance states that it addresses how “the applicant or [someone] acting on behalf of the applicant, of prescription human and animal drug and biological products (drugs) can fulfill regulatory requirements for postmarketing submissions of interactive promotional media for their FDA-approved products.” It defines “interactive promotional media” as including “modern tools and technologies that often allow for real-time communications and interactions (e.g., blogs, microblogs, social networking sites, online communities, and live podcasts).”

The draft Guidance is helpful in at least two respects. First, it states that in general firms are only responsible for content that they control, even if they financially sponsor a website. Although this draft Guidance is expressly limited to prescription drugs and biological products, logically the control principles should extend to medical devices as well.

Second, although the FDC Act requires drug firms to submit copies of promotional materials at the time of their initial dissemination, the draft Guidance states that the FDA will exercise enforcement discretion if the firms submit monthly updates of their promotional material in these types of interactive media. In other words, a firm does not have to send the FDA copies of tweets, Facebook posts, or blog posts every time it issues one. The draft Guidance also discusses how the updates should be provided.

The FDA has also stated that it plans to issue additional Guidance documents addressing other issues related to promotion via social media, such as the issues arising out of character space limitations, the proper use of links, and the obligation, if any, to correct misinformation posted by others. An example of a character space or link-related issue is how a drug firm can provide risk-related and warning information.

A copy of the draft Guidance can be found here.

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About this Author

Olivia Clavio Intellectual Property Attorney
Associate

Olivia M. Clavio is an associate in the Indianapolis office of Barnes & Thornburg and a member of the firm's Intellectual Property Department. She focuses her practice on advertising and marketing compliance, trademark, copyright, trade dress, right of publicity, trade secret, social media, and unfair competition issues.

Olivia assists companies with advertising claims development, substantiation, and defense. She has also represented clients in advertising matters before agencies such as the Federal Trade Commission (FTC) and the National Advertising Division of the Better...

317-231-6444
Joan Long, Barnes Thornburg Law Firm, Chicago and Grand Rapids, Intellectual Property and Litigation Law Attorney
Of Counsel (Retired)

Joan L. Long is retired of counsel in the Chicago and Grand Rapids offices of Barnes & Thornburg LLP, where she is a member of the Intellectual Property Department and chaired of the Advertising and Marketing Group. Ms. Long’s practice focused on intellectual property protection and enforcement with an emphasis on Lanham Act compliance and enforcement.

Ms. Long provided clients with advice and evaluation in connection with advertising claims, including assessment of the substantiation for the claim and potential liability for false or misleading representations of both express and implied claims. Ms. Long assisted clients in negotiating the terms of consent orders, responding to FTC subpoenas and submitting comments to the proposed FTC consent orders. She successfully defended a client’s challenged environmental claim brought before the National Advertising Division (NAD) of the Better Business Bureau. She routinely advises clients on compliance with Federal Trade Commission guidelines.

Ms. Long also represented clients in federal court litigation involving Lanham Act issues, trade secrets and copyright, including a six-day federal jury trial defense victory in May 2013, which was upheld in a 2015 appeal by the Federal Circuit Court of Appeals in a per curium judgment.

312-214-4576
Lynn C. Tyler FDA Compliance Attorney Barnes & Thornburg
Partner

Lynn Tyler helps innovative companies secure and preserve their market position and competitive advantage. He advises on FDA compliance, helps protect clients with patent infringement and validity opinions, helps and enforce intellectual property rights — which often must be asserted against imitators who seek to reap where they have not sown.

An accomplished advocate, Lynn litigates and represents clients involved in virtually all stages of the dispute resolution process, including pre-litigation counseling, alternative dispute resolution, formal and informal...

317-231-7392