In the United States, the primary answer is regulatory uncertainty. FDA has not yet issued final guidance about the proper use of social media, and its limited, draft guidance document is barely a year old (1). The very nature of social media—including its various and different forms, its intrinsically interactive and public nature, and elements of anonymity—poses unique challenges for FDA and life sciences companies.
FDA closely regulates how drug products can be promoted. Companies must submit all promotional materials to FDA and run the risk of receiving letters from FDA's Office of Prescription Drug Promotion (OPDP) if promotional materials are believed to misrepresent a product's safety, efficacy, or risk profile. Further, manufacturers are prohibited from providing even truthful information about uses of drugs or medical devices if such uses have not been approved by FDA. A recent appellate court decision has, however, raised doubts about FDA's prohibition of truthful off-label communications (2), reversing a criminal conviction for off-label promotion on constitutional free speech grounds.FDA has warned manufacturers that "for promotional materials to be truthful and non-misleading, they must contain risk information in each part [of the materials] as necessary to qualify any claims made about the drug" (3). The issue of space is a concern, for example, for any company considering Twitter since its 140-character limit makes it impossible to provide all risk information about a product. Is it enough to provide a link to that information when announcing approval for a new indication? And what if a consumer or a physician tweets in response that the drug also works well for treating a condition for which the drug has not been approved? Does the company have an obligation to respond? Online message boards and Facebook, even YouTube, while not quite as space-limited as Twitter, have practical limits that make it cumbersome to provide "all important safety information." Even if all of the FDA-required information could be provided, this information is dated and could become misleading when new data become available.
FDA held hearings about the use of social media by pharmaceutical manufacturers in November 2009. It took until December 2011, however, for the agency to release its draft guidance (1). Rather than providing broad direction about social media, however, FDA focused on a specific type of request manufacturers might receive.It likely will be more than a year before FDA provides additional guidance. The FDA Safety and Innovation Act (FDASIA), enacted on July 9, 2012, requires the Secretary of Health and Human Services to issue guidance describing FDA's policy on promotion and use of the Internet (including social media) by July 9, 2014.
In the meantime, manufacturers must try to determine what is acceptable by reviewing FDA's draft guidance and letters issued by FDA's OPDP. With the risks of running afoul of FDA and the practical challenges created by social media, it should be no surprise that life-sciences companies are hesitant to offer product-specific Twitter or Facebook pages, YouTube channels, or host online message boards.
Aaron Davidson is a partner in the Life Sciences practice at Baker Botts, focusing primarily on the defense of pharmaceutical and medical device manufacturers.
1. FDA, Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (Rockville, Maryland, December 2011).
2. United States vs. Caronia, No. 90-5006-cr (2nd Cir. Dec. 3, 2012).
3. FDA, Letter to Cephalon, Inc., http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM166238.pdf.