If you follow the blog you will probably remember our April Fools story. This interview with Thomas Abrams in Pharmalot discusses the FDA’s position on its promised social media guidance is actually real, but there are no FDA bouquets.
The FDA’s actions to date
Abrams defended the FDA’s actions to date as consisting of an extensive amount of effort and involving market stakeholders, technology companies, and industry groups. He specifically called out their efforts in the following guidance directions. We are adding our thoughts and predictions to each:
Responding to unsolicited requests for off-label information
This was contained in the Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices and held the following main points:
- Materials cannot “tool the user” to violate regulations through social channels by prompting the asking of questions
- Listen publicly, but respond privately, and only when the drug is referenced by name (condition isn’t good enough)
- The response needs to focus only on the question, but the ISI needs to be comprehensive
- Responses must be non-promotional
This seems pretty straightforward as it’s already in a draft guidance. We would expect these principles to flow through to any social-specific guidance.
Using vehicles that have space limitations for promotion prescription drugs
There is significant guidance about the amount of space reserved for ISI and fair balance information in Guidance for Industry Presenting Risk Information in Prescription Drug and Medical Device Promotion from May, 2009. This document, however, does not address social media in specific so the progress that the FDA has made here is not yet public.
We don’t think the US legal framework will allow the FDA to unilaterally limit the use of social channels such as was done in the UK last year. Instead, we have a good working knowledge in the industry of how to safely use Google SEM ads and other space-limited channels such as Twitter. The guidance will probably enshrine those rules that industry has already developed.
Appropriate use of links
This one was included inside a letter to a supplement company that had so many serious issues that the link mention was really an afterthought. Abrams takes pains to point out that it wasn’t the OPDP that issued the letter and also the issues discussed were much larger than one link.
I know there was mention that the company liked and also linked to their web site misleading information that somebody else put out. … I found the action by that company unusual because the question we get from our stakeholders – companies – is not should we support or further disseminate misleading information that somebody else put out. The question we get is when we see information on a third party web site, what is the best practices that we can correct about their own product?
Links are already well understood from a website perspective. However, social channels pull in many ancillary links when accounts are referenced (see our post on Limits to links: interpreting the FDA’s Like ruling). We feel that the FDA can’t hold companies responsible for the entire internet, so as soon as material is not under their control they no longer hold responsibility for the links contained therein.
Fulfilling the regulatory post-marketing submission requirements of all promotion materials
This is the procedure around Form 2253. The issue here is that the form really doesn’t provide what industry really needs: guidance for social media reporting. The information types included on the form’s instructions mostly predate the Internet never mind social media:
The 2253 form needs an update. Hopefully this will happen in conjunction with the issuance of draft guidance.
Correcting misinformation on independent third-party web sites
This was mentioned in the Off-Label guidance, but was not answered in any substantive way and there has been no guidance that can act as a proxy. To our knowledge no company has received a letter for information on an independent third party site (such as Wikipedia).
It is difficult to hold companies responsible for third-party sites without falling into the “policing the internet” trap. We don’t think that the FDA would follow that route. The question will be whether companies are allowed to request updates from sites such as Wikipedia without then accepting responsibility for those sites.
Timing of the guidance
There was a lot of discussion about the timing of any guidance in the interview, but no firm commitments. Abrams did say that he was confident the FDA would meet the 2014 date imposed by the budget office, but no earlier date was forthcoming.
There is no mention of a Social Media Guidance on the list of priorities for 2013. We still believe that the deadline will be closer to the budget-mandated 2014 date.
We believe the FDA when they say they will have draft guidance by June 2014, so for now we’ll stick to that. These dates have been missed before, however, so we don’t recommend industry hold its breath. Instead, grab a copy of the DHC / Klick Health social media best practices to see what your competition is doing.