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

Barbara Holzer, Broadcast Manager
w. (202) 588-7716

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

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

Symone Sanders, Communications Officer, Global Trade Watch division
w. (202) 454-5108

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


May 10, 2012 

Key House Committee to Vote on Legislation That Would Weaken Medical Device and Prescription Drug Regulations

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

This morning, the U.S. House of Representatives Energy and Commerce Committee will meet to deliberate and vote on legislation that bows to the powerful interests of industry by weakening medical device and prescription drug safety.

The primary purpose of the bill is to renew and extend the Food and Drug Administration’s (FDA) user-fee programs for prescription drugs and medical devices, fees that the agency has become dependent on to fund much of its critical regulatory work because of inadequate direct funding being provided by Congress. However, the bill includes many provisions unrelated to user fees that would amend medical device and prescription drug regulations.

While the bill being considered by the committee today contains some important improvements in comparison to earlier drafts of the bill – which we strongly opposed – the limited number of positive provisions in the revised bill still is offset by:

(1) The inclusion of multiple provisions sought by industry that would weaken the already inadequate oversight of medical devices and drugs and pose a risk to the health and lives of patients; and

(2) The exclusion of several simple, commonsense proposals for strengthening medical device safety opposed by industry.

Therefore, in balance, this bill would have an overall negative impact on medical device and drug safety, and we oppose its passage unless significant amendments are made. For example, a provision should be added closing the dangerous loophole in what is known as the 510(k) process that allows the FDA to clear a new moderate- or high-risk device for marketing based on its similarity to an older device already on the market, even if the older device has been removed from the market because it injures or kills patients. Another provision should be added prohibiting the FDA from clearing class III medical devices – the most risky type of devices – from being cleared through the 510(k) process and instead require the agency to review such devices under the more rigorous premarket approval application process.

Ensuring that the medical devices and drugs used to treat patients in the U.S. are safe and effective should be the paramount goal of any new medical device and prescription drug legislation. Patients in the U.S. deserve legislation that strengthens the FDA’s review and oversight of these medical products to ensure their safety and effectiveness, not legislation that seeks to promote the corporate interests and profits of industry by weakening such review and oversight.

See our detailed review and analysis of the House bill. Get more background here.


Public Citizen is a national, nonprofit consumer advocacy organization based in Washington, D.C. For more information, please visit www.citizen.org.

Copyright © 2015 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


Together, two separate corporate entities called Public Citizen, Inc. and Public Citizen Foundation, Inc., form Public Citizen. Both entities are part of the same overall organization, and this Web site refers to the two organizations collectively as Public Citizen.

Although the work of the two components overlaps, some activities are done by one component and not the other. The primary distinction is with respect to lobbying activity. Public Citizen, Inc., an IRS § 501(c)(4) entity, lobbies Congress to advance Public Citizen’s mission of protecting public health and safety, advancing government transparency, and urging corporate accountability. Public Citizen Foundation, however, is an IRS § 501(c)(3) organization. Accordingly, its ability to engage in lobbying is limited by federal law, but it may receive donations that are tax-deductible by the contributor. Public Citizen Inc. does most of the lobbying activity discussed on the Public Citizen Web site. Public Citizen Foundation performs most of the litigation and education activities discussed on the Web site.

You may make a contribution to Public Citizen, Inc., Public Citizen Foundation, or both. Contributions to both organizations are used to support our public interest work. However, each Public Citizen component will use only the funds contributed directly to it to carry out the activities it conducts as part of Public Citizen’s mission. Only gifts to the Foundation are tax-deductible. Individuals who want to join Public Citizen should make a contribution to Public Citizen, Inc., which will not be tax deductible.


To become a member of Public Citizen, click here.
To become a member and make an additional tax-deductible donation to Public Citizen Foundation, click here.