For many years, the pharmaceutical industry has been crying out for improved guidance on its use of social media from the Food and Drug Administration (FDA), arguing that current regulations have not kept up with the online behavior of health consumers and doctors in the digital age.
Even well before the long-awaited 2009 FDA ‘Public Hearing on Promotion of FDA-Regulated Medical Products using the Internet and Social Media Tools’, the pharmaceutical industry was cautious about its use of new digital channels, sometimes looking to the actions of other companies as a benchmark of acceptable activity and learning only through corrective action such as the FDA Google advertising warning letters sent to fourteen pharmaceutical companies in March 2009.
In January 2014, FDA finally issued draft guidance on the use of interactive promotional media but many in the pharmaceutical industry were still left wondering how to engage online in a compliant way.
So there is some excitement in the industry at this week’s news that United States Representative Billy Long has introduced new legislation to update FDA’s guidance. A statement on Long’s website says that more than half of Americans use the Internet to research medical products, yet current regulations discourage companies from publishing accurate informational content online.
According to the statement, Long is the lead sponsor of H.R. 2479, a bill which would force FDA to change regulations on how pharmaceutical companies share product information with the general public.
“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. One would think something as important as personal decision-making for health care would be easy to get economic and scientific data to back up the drug’s effectiveness. This bill would simply push FDA to update its regulatory approach to communications to keep up with today’s technology,” Long said.
Long’s website points out that despite the popularity of Facebook and Twitter, drug manufacturers cannot confidently share, without fear of legal repercussions, product information on the online platforms with a link to detailed information.
One of Long’s arguments for FDA to update its guidance is that the regulator itself uses social media platforms for announcing accurate and truthful drug information.
“The FDA uses Twitter to link its announcements to more comprehensive information. It is commonsense for the federal government to allow drug manufacturers to use these platforms in a similar fashion”, he says. “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.”
No help for global pharma?
One thing that is unlikely to come from new any FDA guidance is clarity for pharmaceutical companies about the impact of their US social media activity on international markets, which fall outside of FDA’s jurisdiction – last June’s FDA Guidance on Twitter was largely irrelevant for global pharma.
Markets outside of the US are of course regulated by their own governments and most do not allow a company to promote products to patients – a practise which is allowed and regulated in the US. This means that we may find once again that instead of answering pharma’s social media questions, updated FDA guidance may simply pose new ones.
Long’s bill has been referred to the House Energy and Commerce Committee, of which Long is a member. As we’ve said before, this story is [still] far from over.