Tuesday, July 10, 2012

Start the Clock: 730 Days, 729 Days . . .

Yesterday the President signed into law the Food and Drug Administration Safety and Innovation Act.  Here’s what the White House Press Secretary had to say about that:

On Monday, July 9, 2012, the President signed into law:
. . .
S. 3187, the “Food and Drug Administration Safety and Innovation Act,” which reauthorizes a number of FDA user fee programs, including the Prescription Drug User Fee Act and Medical Device User Fee and Modernization Act, and increases FDA’s ability to provide timely and expedited review and approval of applications for prescription drugs and medical devices; authorizes new user fee programs for generic drugs and biosimilar biological products; extends and modifies FDA authorities related to drugs intended for use by children; and improves the drug approval process and helps to reduce drug shortages.

That’s all well and good.  But nestled deep within the text of the Act, is a Miscellaneous Provisions subsection that many drug and device counsel will be genuinely excited about:

Subtitle C--Miscellaneous Provisions
SEC. 1121. GUIDANCE DOCUMENT REGARDING PRODUCT PROMOTION USING THE INTERNET.
Not later than 2 years after the date of enactment of this Act, 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.

(Bold and italics emphasis added.)  That sound you just heard was a collective “It’s about time” coming from in-house counsel at drug and device companies across the country.  They have been patiently waiting for guidance on the industry’s use of the internet and social media for quite some time now, and, while they aren’t going to get it yet – it may take two more years – this is an improvement.  Up to now, this has been a waiting game that has left many of us wondering whether the FDA would ever issue meaningful guidance.  Now we know that something’s coming.

This has been a real issue for in-house counsel.  The internet and, in particular, social media have become wildly popular destinations for people looking to gather and discuss information about drugs and medical devices.  And so companies, who often have the most information about these products, have sought to engage their customers on those forums.  But such interaction raises risks and questions: What will the FDA find proper and what will it not?; Is a short statement with a link to more detailed disclosures sufficient?; Does the company have responsibility for what third-parties might say on a social media site?; Does the company have reporting responsibilities for information it learns on a social media site?  And so on. 

As we know, all these questions inevitably fall into the laps of in-house counsel.  And, while predicting what the FDA will find proper is never easy, to date answering these types of questions about the internet and social media has been a guessing game. 

In the past, the FDA acted as if it was readying itself to do something.  But that was a long time ago.  In November 2009, the FDA held a Hearing on Promotion Using the Internet and Social Media Tools.  The FDA invited all sorts of stakeholders, from industry representatives to consumer advocates.  Presenters noted the lack of clarity surrounding the healthcare industry’s obligations regarding social media.  Issues were discussed.  Solutions were proposed.  And positions were argued.  Since then, the FDA has issued no further guidance. 

It was not until over two years later, December of last year, that the FDA issued any guidance at all.  It was a draft guidance that addressed off-label communications.  The guidance, however, only partly addressed the internet and social media and, in some ways, raised more questions than it answered.  And since then the FDA has issued no further guidance. 

So, in the absence of meaningful guidance, we’ve been left to guess at the FDA’s positions.  In fact, just a few weeks ago, I and others authored an article in Corporate Counsel that made educated guesses as to how the FDA might come out on certain issues by interpreting warning letters, extrapolating from the FDA’s past positions on the use of other, different media, and looking to common industry practices.  But, educated or not, they were guesses.  That certainly isn’t a comfortable position from which to make decisions as in-house counsel.

And that’s why the mandate contained in a miscellaneous provision of the new Act has brought smiles to the faces of many in-house counsel.  While it’s not here yet, we know it’s coming.  It’s the law.  728 days, 727 days . . .

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