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Focus on Regulation

Tag Archives: off-label

House Subcommittee on Health Opens Floor for Discussion of FDA Regulation of Off-Label Speech

The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills seeking to amend the Federal Food, Drug, and Cosmetic Act (“FDCA”) to clarify how drug and device manufacturers can legally discuss uses of

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

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As discussed in our earlier post, FDA solicited comments in a Federal Register notice on its “Draft Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Devices.”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

Industry Waits for Some Signal That FDA Will Rethink Its Proposed Approach to Unsolicited Requests

With the comment period closed, industry stakeholders wait for some indication that FDA will rethink its approach to responding to unsolicited requests, as set forth in FDA’s draft guidance, Guidance For Industry – Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.  Since release of the draft in December 2011, stakeholder

Hogan Lovells Comments on the FDA’s “Draft Guidance on Responding to Unsolicited Requests”

The FDA issued its Draft “Guidance for Industry: Responding to Unsolicited Requests for Off-label Information About Prescription Drugs and Medical Devices” in December 2011.  As our FDA group follows these issues closely on behalf of the industry, we filed a Comment on this draft guidance encouraging the agency to reconsider and clarify certain elements of the Draft Guidance,