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Focus on Regulation

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 their products that are not described in their labeling.  This hearing represents the latest development in the recent flurry of activity surrounding the U.S. Food and Drug Administration’s regulation of manufacturer communications related to unapproved uses of their products since FDA’s issuance of two draft guidances and a First Amendment memorandum right before the change in administration earlier this year.

The first bill seeks to limit the definition of intended use of drugs and devices by amending FDCA Section 201A to prevent the intended use of a drug or device from being determined by reference to (1) actual or constructive knowledge that the product will be used “off-label” in a manner that differs from the use for which it is cleared, approved, or licensed; (2) non-public manufacturer statements about the product that are not included in any promotional materials or statements to third parties; or (3) communications considered to be scientific exchange.  The proposed bill also would add a scientific exchange “safe harbor” for dissemination of off-label information about a drug or device.

The second bill seeks to amend the definition of false or misleading labeling by amending FDCA Section 502(a), which allows for provision of certain health care economic information to entities making coverage decisions, to explicitly include devices, as well as drugs.  It also includes a new paragraph exempting the provision of such information to these entities from the misbranding provisions of the act if the information is based “on competent and reliable scientific evidence and relates to an investigational use of a drug or device.”  The proposed language goes on to define specific criteria for when information related to an investigational use of an approved, cleared, or licensed drug or device may be provided.

Interested parties can attend the hearing in person in room 2322 of the Rayburn House Office Building or via webcast, which will be available at http://energycommerce.house.gov/.