Last month, Politico reported on the communications aspects of the 21st Century Cures Act (the Act) – also known as H.R. 6 – the sweeping legislation that addresses a range of issues related to medical research and access to medicines. The expansive subject matter of the proposed bill includes funding for new kinds of research, the establishment of new methodologies for clinical trials, creation of new pathways for devices, and providing clarity on expanded access. to name a few. If you want to catch up on the full range of contents, you can find a two page summary here, a more in-depth section by section summary here; and a set of FAQs here, all provided by the House Committee on Energy and Commerce.
For those who have not been following the evolution of the bill, a prior version had thankfully included specific direction for FDA to issue clear guidance with respect to the use of the Internet and social media by industry, recognizing the heavy patient use – and even FDA’s use – of social media and its role in healthcare communications today. The bill has momentum in the House having unanimously been voted on in Committee and may face a vote this week. Unfortunately, the language related to specific FDA guidance in this regard was dropped from the current version. The bill still references guidance from FDA on facilitating responsible communication, but is silent with regard to the specific topic of digital media.
Once the language was dropped. Rep. Billy Long (R-MO) introduced stand-alone legislation – H.R. 2479 – that would again address the need for FDA to issue guidance related to the use of digital media. In a release from Rep. Long he stated:
“My bill will lead to enhanced, effective and accurate communication between drug manufacturers, doctors and patients. It is now the norm to go online, whether on social media or other online platforms, and find needed information on just about anything… This bill would simply push FDA to update its regulatory approach to communications to keep up with today’s technology… My bill will allow the companies, which know their products best, to state introductory information with a link to more details, just like the FDA does.”
The Congressman deserves credit, trying to address through legislative means what has been realized by many through several years of waiting for meaningful guidance from FDA after its 2009 meeting – that the guidance given falls considerably short of what is needed.
Legislation that would prod the agency into action on this front would be welcome. But while it addresses the symptom, it does not address the underlying problem – the process for producing guidance of any kind. Right now, insight into how the agency regulates communications comes from two sources – guidance documents or warning letters. Neither are good methods for enunciating regulation. FDA needs not only to be directed into producing meaningful guidance related to digital and social media and medicine, but also in employing a methodology to produce guidance – one that abandons the current methods that are time-consuming and lacking in transparency. While that perhaps is too much to hope for and in the meantime Rep. Long’s shot at providing greater clarity related to digital social media guidance reform is something to keep our eye on.