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Focus on Regulation

FDA’s Unsolicited Requests Docket is Closed – 35 Commenters address various issues, including First Amendment

As discussed in our earlier post, FDA solicited comments in a Federal Register notice on its “Draft Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Devices.”  See 76 Fed. Reg. 82303 (December 30, 2011).

As of March 29, 2012, the docket is technically closed.  The docket features 35 comments submitted by biopharmaceutical companies, trade organizations, and other interested persons, including one submitted by Hogan Lovells, generally, and another by Hogan Lovells on behalf of Actelion Pharmaceuticals Ltd. 

The comments raise various issues and concerns with the Draft Guidance, including the possibility that the Draft Guidance infringes upon biopharmaceutical companies’ First Amendment right to free speech:

  • Discussions among health care professionals and scientists, including responses by a biopharmaceutical company to unsolicited requests, constitute scientific expression and are subject to the highest level of First Amendment protection. 
  • The Draft Guidance recommendations that would prevent public responses to public unsolicited requests for off-label information are content and speaker-based restrictions of speech. 
  • The standard for speaker/content-based restrictions is “heightened judicial scrutiny,” regardless of whether the speech is commercial or not. 
  • Sorrell held that government may not suppress truthful, non-misleading speech about otherwise lawful activity. 
  • FDA has been on an “extended losing streak” in the courts with respect to the First Amendment.

We will provide an update when FDA finalizes its guidance.