In its earliest days, social media had the emphasis on “social”—Facebook, YouTube and Twitter were platforms that allowed people to keep in touch. By 2007, the emphasis clearly shifted to the “media” half of the equation. Social media became a primary means for people to get news—the news they specifically were interested in, would want to comment on and then pass along to their friends and acquaintances.
In that new digital age, health quickly established itself as one of the most popular areas on the Internet. Social media, in particular, emerged as a tremendous resource for consumers and practitioners alike. Patients surfed for information and research on their diseases or suspected diseases, while physicians stayed up to date on treatments and research, and started to even collaborate online.
Yet, years after the arrival of the e-health phenomenon, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) still has not developed clear guidance on how and if the pharmaceutical industry might take advantage of this educational tool. The OPDP already closely regulates print and broadcast communications by pharma, where potential problems are easier to predict. But digital media—given its speed and reach and potential for inaccuracy and confusion—raised questions the agency hadn’t addressed before, leaving the industry to tiptoe around territory where no clear boundaries exist.
As a result, for too many in pharma, digital media –particularly social media—became a “no-try zone.” Why venture forth when you’re apt to get slapped by regulators or provoke a communications crisis? For many in the industry, the motto on using social media to talk to patients was a simple, ”Don’t go there.”
But is social media and digital really as off-limits as some in pharma seem to think? The lack of formal guidance doesn’t mean the FDA hasn’t weighed in at all. The industry also might see the agency’s intent based on “Warning Letters” for serious violations or “Untitled Letters” for lesser infractions. To get a true read on the situation, we performed an analysis of FDA enforcement patterns that would help fill in any gaps and clear up misperceptions.
To do that, we used a database we assembled of FDA regulatory action letters going back through 2004. The research covered nearly 1,000 violations, tracking them by company, type of drug, indication, type of violation, whether it was a Warning Letter or Untitled Letter issued—and most importantly, whether the communications violation involved a digital or traditional media property. When answering this question about social and pharma, we looked only at a subset of those letters that coincided with the ascendency of the use of social media—from 2008-2012.
What we found would surprise some. Despite the large-scale use of digital communications properties by some, mostly larger, pharmaceutical companies, traditional media still garnered the majority of violations cited by FDA’s OPDP during the time frame studied.
Further, we found that when we reviewed the more serious types of letters—Warning Letters—we found that there were 12 Warning Letters regarding digital communications, but 36 letters aimed at traditional media properties.
These figures represent regulatory enforcement vis a vis digital media, but when you look to social media in particular, during the four-year period, there was only one regulatory action letter aimed at the use of a social media platform.
While perception is important, an industry needs to base its behavior on evidence—just as pharma does when researching a drug’s side effects. Our analysis does not make a judgment call that digital media is less risky than traditional media, but it does give us a true picture that the migration of both patients and pharma into digital media has not resulted in an open floodgate of regulatory actions.