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Testimony Before the FDA’s Public Hearing on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products

View Dr. Sidney Wolfe’s testimony.

View Dr. Michael Carome’s testimony.

View press release.

Public Citizen testified at a Food and Drug Administration (FDA) public hearing on “off-label marketing” – the pharmaceutical and medical device industry practice of marketing medications and medical devices for unapproved uses. Public Citizen experts explain that restrictions on marketing for unapproved uses are crucial to protecting patient health. Promotion of medical products for unapproved uses threatens patients because it undermines the long-standing regulatory framework for ensuring that medications and medical devices are safe and effective for their intended uses.

View our other work related to off-label use of drugsdrug promotion, and medical device promotion.