Pharma Social Media FDA Regulations

The long-awaited FDA guidelines regarding pharma and device companies’ social media activities have finally arrived – sort of. More than two years have passed since the FDA held a two-day public hearing regarding the online promotion of drugs and medical devices. The purpose of the hearing was to gather information that would help the agency make policy decisions, but two years later, it seemed the jury was still out. Then just as 2011 came to a close, the FDA published a draft guidance called, “Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.”

The recommendations were not particularly enlightening as they only address, as the title suggests, unsolicited requests for off-label information. Meanwile, bigger questions remain unanswered regarding accountability for the online reports of adverse events and correcting misinformation. The FDA says they intend to address these issues and more in time.

Healthcare as an industry has been somewhat slow to embrace social media, and drug and device makers may have more reason than most for their hesitancy. The FDA’s strict regulations around the reporting of adverse events have been the primary concern. Pharma companies especially fear being innundated with reports of adverse events that could result in massive amounts of paperwork and a potential recall of the product in question. However, a recent study shows that so far at least, the percentage of online posts and comments referencing adverse events is relatively low, and yet without guidelines in place, the monitoring, responding, and reporting of these types of online comments remains fraught with uncertainty.

Because of the highly regulated nature of the pharma industry, Facebook initially granted pharma companies the option to block public commenting, but that exception was revoked in August of 2011. As a result, the Washington Post reports that companies such as AstraZeneca, Johnson & Johnson, and Purdue Pharma decided to take several of their pages down; Purdue said they may reevaluate the decision once the FDA issues guidelines for online engagement.

If companies are waiting for the FDA to issue a detailed Facebook rulebook, they will most certainly keep waiting. Dale Cooke, vice president and group director of regulatory review at Digitas Health, explained to the Wall Street Journal’s Health Blog that it would be impossible for the FDA to issue guidelines specific to any one social network because of the transient nature of these platforms. However, he points out that both Twitter and YouTube were mentioned by name in examples contained in the intial draft guidance so it’s clear that they are factoring social media into the equation.

So where do drug and device companies go from here? Most will continue to cautiously navigate the world of online marketing without comprehensive FDA guidance, at least until further information is published. But considering it took two years to issue the first draft guidance, that may take awhile. In the meantime, how is your company using social media? Do you think sales reps should engage in the online conversation? Does your company have a policy in place for if or how sales reps and other employees should respond if they come across incorrect information or adverse events related to one of your company’s products online?