» Drug, Devices, and Supplements

» Physician Accountability

» Consumer Product Safety

» Worker Safety

» Health Care Delivery

» Auto and Truck Safety

» Global Access to Medicines

» Infant Formula Marketing


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

April 19, 2017

View as PDF.

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.

Copyright © 2017 Public Citizen. Some rights reserved. Non-commercial use of text and images in which Public Citizen holds the copyright is permitted, with attribution, under the terms and conditions of a Creative Commons License. This Web site is shared by Public Citizen Inc. and Public Citizen Foundation. Learn More about the distinction between these two components of Public Citizen.

Public Citizen, Inc. and Public Citizen Foundation


You can support the fight for greater government and corporate accountability through a donation to either Public Citizen, Inc., or Public Citizen Foundation, Inc.

Public Citizen lobbies Congress and federal agencies to advance Public Citizen’s mission of advancing government and corporate accountability. When you make a contribution to Public Citizen, you become a member of Public Citizen, showing your support and entitling you to benefits such as Public Citizen News. Contributions to Public Citizen are not tax-deductible.

Public Citizen Foundation focuses on research, public education, and litigation in support of our mission. By law, the Foundation can engage in only very limited lobbying. Contributions to Public Citizen Foundation are tax-deductible.