Learn more about our policy experts.

Media Contacts

Angela Bradbery, Director of Communications
w. (202) 588-7741
c. (202) 503-6768
abradbery@citizen.org, Twitter

Don Owens, Deputy Director of Communications
w. (202) 588-7767

Karilyn Gower, Press Officer
w. (202) 588-7779

David Rosen, Press Officer, Regulatory Affairs
w. (202) 588-7742

Other Important Links

Press Release Database
Citizen Vox blog
Texas Vox blog
Consumer Law and Policy blog
Energy Vox blog
Eyes on Trade blog

Follow us on Twitter


March 1, 2017

Trump’s Joint Address Attack on FDA Signals Complete Ignorance of Medication Approval Process

Statement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group

Note: Tuesday night, President Donald Trump gave his joint address to the nation. In it, he suggested that the U.S. Food and Drug Administration (FDA) prevents a host of new medications and medical devices from hitting the market.

President Trump’s claims that the U.S. Food and Drug Administration’s approval process for medical products is “slow and burdensome” and “keeps too many advances … from reaching those in need,” reflect complete ignorance about the FDA’s current regulatory schemes for ensuring that medications and medical devices are safe and effective.

For example, over the past three decades Congress has created, and the FDA has routinely used, several pathways for expediting the review and approval of promising new medications for treating serious or rare diseases. Indeed, since 2000, the FDA has reviewed applications for novel medications more quickly, on average, than its counterparts in Canada and Europe, and the vast majority of these new products were approved first in the U.S.

And most high- and moderate-risk medical devices are quickly cleared by the FDA for marketing in the U.S. without undergoing testing in well-designed human clinical trials.

The regulatory pendulum for the FDA’s review of medical products already has swung too far toward promoting speed over the rigor of evidence demonstrating safety and effectiveness. Trump’s reckless proposal to slash FDA regulations in an effort to further speed FDA’s review of medical products would dangerously undermine FDA’s approval processes and lead to countless preventable injuries, deaths and illnesses across the U.S.


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.