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Focus on Regulation

Recent First Amendment Rumblings

Lately, there seems to be a palpable uptick in news related to FDA’s regulation of off-label communications.  Here are some of the developments we’ve been following:

In April: 

  • CDER Director Janet Woodcock noted in her remarks at the FDLI Annual Conference that the agency is “currently evaluating our advertising policies in light of first amendment issues … that is something we are doing very diligently right now.”
  • FDA Chief Counsel Elizabeth Dickinson announced that the agency will hold a public meeting this summer to address industry’s first amendment concerns about FDA’s restrictions on off-label promotion.
  • PhRMA published an article in the Food and Drug Law Journal calling on FDA to establish a “clear safe harbor” for manufacturers to share data and information with healthcare professionals about off-label, medically accepted uses of FDA-approved products.

Last week:

  • On May 6th, FDA announced it was withdrawing 47 draft guidance documents that were published before December 31, 2013 but never finalized.  This en masse withdrawal was part of a broader action plan to resolve a much larger number of draft guidance documents published before December 31, 2013.  This broader action plan noted that the 2011 draft guidance on responding to unsolicited requests for off-label information would be reissued, with a target date of 2Q 2015.
  • Yet the next day, trade press reported that FDA plans to delay issuance of the unsolicited requests guidance until after the public meeting this summer.
  • Also on May 7th, Amarin Pharmaceuticals, Inc. and four New York-based doctors filed a complaint against FDA in the U.S. District Court for the Southern District of New York seeking, among other things, a declaratory judgment that they can engage in truthful and non-misleading speech about an off-label use of Vascepa® (icosapent ethyl) without fear of criminal prosecution or civil liability.

While all of these developments are quite interesting, it’s unclear whether FDA intends to provide guidance anytime soon.  Last year FDA had signaled, through its responses to citizen petitions filed by the Medical Information Working Group, that some clarification would be forthcoming.  Now, with a public meeting to hear stakeholder views promised in the summer (but with no specific meeting details announced yet), it’s looking less likely that the agency is on the cusp of issuing new guidance on the increasingly fraught topic of off-label communication.

We’ll be tracking developments on this topic (and other advertising/promotion topics in FDA’s 2015 guidance agenda, such as health care economic information and use of links to third-party sites), so check back again.