Monday, April 22, 2013

FDA Says That It Knows That the Clock Is Ticking on Internet and Social Media Guidance

Our readers know that we’ve been posting about the FDA’s obligation to issue guidance on promotion of medical products using the Internet and social media for some time, in particular since the President signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA), which gave the FDA until July 9, 2014 to issue such guidance.  We wrote about it here, and updated it here and here.  The clock is ticking and has been for some time. 

Last week, the FDA spoke – not to issue guidance, but to tell us that it’s working on it.  Pharmalot published an interview with the Director of the FDA Office of Prescription Drug Promotion (OPDP), Thomas W. Abrams.  It’s a good interview and worth reading.  Our biggest take away is that the FDA has made issuing guidance a priority.  Here’s what OPDP Director Abrams said:

The development and issuance of guidance for social media is among the highest of FDA’s priorities. . . .  So as a result, we have committed and extensive amount of resources, both in time and human resources to develop a guidance. We have done a lot of work . . . .”

He also indicated that the FDA grasps key issues that industry, and others, would like addressed:

. . .  So we have identified relevant issues, including responding to unsolicited requests for off-label information, using vehicles that have space limitations for promotion of prescription drugs, appropriate use of links, fulfilling the regulatory post-marketing submission requirements of all promotion materials and correcting misinformation on independent third-party web sites.

Good and good. 

On the other hand, of course this should be a priority.  Congress told the FDA to get it done.  The Internet, social media and their extensive use by the public to research medical products has been no secret, nor have the promotional issues that surround them.  The FDA held a public hearing on it years ago.  They heard from industry and other stakeholders then and have been hearing from them ever since.     

So why has it taken so much time?  OPDP Director Abrams had an answer for that, and it’s what we expected.  The FDA is concerned about issuing guidance amidst the shifting sands of the Internet and social media:

. . . It takes time because we follow good guidance practices and we want guidances that are well vetted and really address relevant issues, and stay relevant for a time period. It would be easier to come out with a guidance in a shorter time that may not be relevant as technology changes. One thing we know is that we can’t predict it, but we know technology is going to keep changing quicker and quicker. So we want this guidance to be applicable, regardless of which technology platform comes in the future or changes that existing platforms may make in the future.

We understand.  That’s a legitimate concern.  Everybody wants the FDA to issue something that’s meaningful and will work in the long run.  And, while it’s tough to explain away 5 years of waiting, we’re glad that the FDA chose to publicly announce that it’s working on it.     

The FDA also seems to know that it’s under a deadline.  We say “seems to know” because Director Abrams put it this way: “there’s a provision, Section 1121 in FDASIA, that provides a timeframe as far as guidance development and that would be July 2014.”  July 2014 is right.  July 9, 2014 to be exact.  But it’s not really a timeframe.  It’s a deadline.  Here’s how Congress put it: 

Not later than [July 9, 2014], the Secretary of Health and Human Services shall issue guidance that describes Food and Drug Administration policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by such Administration.

(Emphasis added.)  We all know what it means when “shall” is used.  It’s a deadline. 

There are other interesting tidbits in the interview, including OPDP Director Abrams take on the LA District Office’s Warning Letter that addressed a company “liking” a Facebook post, the one-click rule (the FDA has never announced such a rule), and whether promotion can be properly accomplished under space limitations, such as the 140-world limitation on Twitter (Director Abrams seems to signal that it can be).  We refer you to Pharmalot’s excellent interview for the full discussion of those issues. 

For our part, we were glad to read that the FDA has made this a priority.  But one thing: It’s a deadline, not a time-frame.  The clock is ticking.  436 days, 435, 434 . . .

1 comment:

Soronel Haetir said...

So long as the statute does not contain a penalty for failure to comply that "shall" is pretty meaningless.