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

Nicholas Florko, Communications Officer, Global Trade Watch
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 29, 2012

Legislation Could Block Public Access to Drug Safety Information

Congress Should Remove or Narrow Provision That Would Restrict Public Access to Important Health and Safety Information

Washington, D.C. – A provision in the Food and Drug Administration Reform Act that would block public access to potentially important health and safety information should be removed or substantially narrowed, Public Citizen and 20 other groups said in a letter sent today to key lawmakers.

Section 812 of the Food and Drug Administration Reform Act (H.R. 5651), which will be voted on by the U.S. House of Representatives on Wednesday, allows the FDA to deny the public access to information relating to drugs obtained from a federal, state, local or foreign government agency if the agency has requested that the information be kept confidential. The Freedom of Information Act (FOIA), however, already provides exemptions to protect against the release of many law enforcement records, confidential commercial information and trade secrets, the letter said.

“The provision would create an overly broad exemption under FOIA – with no explanation of need by the entity that wants to keep the information secret,” said Julie Murray, a staff attorney with Public Citizen. “If passed as is, the legislation could push some of the FDA’s work into the shadows.”

The provision also would allow the FDA to withhold covered information forever, even long after any need for secrecy has passed. At a minimum, the provision should be narrowed to avoid unintentionally and unnecessarily increasing secrecy at the agency, the letter said.

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

In parallel legislation, the U.S. Senate narrowed a similar provision by accepting an amendment by Sen. Patrick Leahy (D-Vt.) that would limit the scope of the FOIA exemption to information voluntarily provided by foreign governments, require that the request to keep the information confidential be in writing and, unless otherwise agreed upon, specify a time frame after which the information would no longer be treated as confidential.

The letter was addressed to U.S. Rep. Fred Upton (R-Mich.), chair of the House Energy and Commerce Committee, and Rep. Henry Waxman (D-Calif.), ranking member of the committee. The groups asked the lawmakers to address the problem before the floor vote or in conference committee, when the House and Senate bills are reconciled.


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

Copyright © 2016 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.