Comments to the FDA on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products

April 19, 2017

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In comments to the Food and Drug Administration (FDA) on manufacturer communications regarding unapproved uses of approved or cleared medical products, Public Citizen discusses the risks to patients when manufacturers promote their products for unapproved uses and the unreliability of journal articles as a basis for physicians’ decisionmaking. We also explain that the First Amendment does not support the industry call for relaxation of the restrictions on promoting products for uses that the FDA has not approved as safe and effective for patients.