FDA Proposes Social Media Guidance on Off-Label Drug Use

It’s estimated that one in five prescriptions treat ailments other than those for which the drug was originally intended. Off-label use of pharmaceuticals and medical devices, as this practice is called, is big business. But for manufacturers seeking to inform the public about the benefits and dangers of using medications off-label, it’s also risky business: while doctors are permitted to prescribe drugs for alternative uses, the companies that make those drugs can face significant fines for promoting or marketing their products – to physicians or consumers – for conditions other than those for which US Food and Drug Administration approval was received. 

Because that makes it difficult for consumers to find information on products that may help them, since 1997 the FDA has allowed drug and medical device manufacturers to respond to unsolicited requests for information regarding off-label use. And late last month, the FDA proposed new rules that begin to address what manufacturers can and cannot say about off-label drug use in the context of emerging electronic media. For your reference, here’s a roundup of legal commentary and analysis on the proposed new rules:

Responding to Unsolicited Requests for Off-Label Information – New FDA Draft Guidance (King & Spalding):

“The Food and Drug Administration (FDA) issued a draft guidance on December 30, 2011 in response to stakeholder requests for clarification on how manufacturers and distributors of prescription drugs and medical devices can respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use (off-label information)… Among multiple recommendations, the draft guidance addresses how firms should respond to requests for off-label information that occur in public forums, including the internet and electronic social media.” Read more»

FDA Issues Draft Guidance, Requests Public Comments on Communication of Off-Label Information (McDermott Will & Emery):

“The agency notes that there have been changes to communications brought about by the rise of social media and defines a public unsolicited request to include a request made via emerging electronic media, such as a product website, discussion board, chat room or other public electronic forum.” Read more»

FDA Issues Two Important Documents Concerning Communication of Off-Label Information (Ropes & Gray LLP):

“If a company chooses to respond to a ‘public’ request (i.e., any request that is not one-on-one, such as on an Internet discussion board or at a company-sponsored speaker program)… no substantive off-label information should be provided in the response, even if in response to an unquestionably unsolicited question, regardless of the size or composition of the audience or the medium in which the exchange occurs; rather, the individual asking the question should be invited to follow up with the company’s medical or scientific affairs department…” Read more»

FDA Gets (Un)Social (Morgan Lewis)

“Despite not being focused solely on social media, the new draft guidance ventures into previously uncharted territory by addressing how organizations should respond to individual comments made in public forums—including websites and blogs (even mentioning YouTube and Twitter by name)—in addition to those made during face-to-face meetings and speaking events, suggesting that this may be the first of what FDA has indicated will be a handful of guidances addressing social media–related issues.” Read more»

FDA, Off-Label Uses and the Internet – Something New for 2012 (Well sort of) (Dechert LLP):

“But, the FDA is still trying to hide the off-label ball; trying to force anything substantive to be non-public. Drug and device manufacturers have long been aware of the FDA’s rules regarding how it should respond to non-public requests (phone calls, direct emails, one-on-one communications) for off-label information about their products and those rules really haven’t changed – the response has be specifically tailored, truthful, non-misleading, accurate, balanced, and scientific.” Read more»


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