Bill in Congress Could Limit Access to Drug Safety Information

"Open Government" cartoon (Source: Adam Zyglis, Buffalo News)The U.S. House of Representatives is scheduled to vote Wednesday, May 30, on the Food and Drug Administration Reform Act of 2012, H.R.5651. Groups advocating for open and transparent government have found a provision in the bill that would keep potentially important health and safety information away from the public. Section 812 would, according to a letter to leaders of the House Oversight and Government Reform Committee penned by several of these groups, deny the public access to information relating to drugs obtained by the U.S. Food and Drug Administration (FDA) from any government agency -- local, state, federal, or foreign -- if that agency has requested that the information be kept confidential.

Patrice McDermott, Executive Director of, which works with the legislative and executive branches to encourage more open government, told the Center for Media and Democracy (CMD) that the provision might blow a huge hole in the Freedom of Information Act (FOIA). It would give the FDA carte blanche with regard to drug information.

Deadly Drugs, Foreign Multinationals

Clinical Trial Results Under the Rug CartoonWhy is this a problem? Take the example of a cancer drug that's manufactured overseas. Due to a problem in its manufacturing, certain batches are contaminated, making it dangerous or even lethal to those taking the drug. The company issues a voluntary recall, and health agencies across the world assist in disseminating the information to protect patients. So far, so good.

Under this new provision, if the foreign government agency with jurisdiction over the pharmaceutical company were to give the FDA information pertaining to an internal process that could lead to a repetition of this deadly problem, it could request that the FDA keep the information confidential. It could do this to protect corporate trade secrets or for any other reason. Consumer advocates and the public would be denied critical information for tracking the safety and soundness of the drug.

Senate Agrees to Modify the Bill, House Does Not

Senator Patrick Leahy (D-VT) introduced an amendment to the Senate version of the bill, S.3187, which would preserve FOIA. According to McDermott, the amendment limits the exemption from FOIA to information about drug investigations and inspections that foreign governments share with the FDA on condition of keeping it confidential. The new provision would allow the FDA to receive and keep the information confidential for up to three years (or longer if specified in writing), but the foreign government in question has to request in writing that the information be kept confidential, and specify a time period.

The original language remains in the House version of the bill. According to Julie Murray, attorney for the consumer group Public Citizen, the way the provision is drafted, a sharing agency -- local, state, federal, or foreign -- that gives information to the FDA would need only to request that the information be kept confidential verbally to blow a hole in the current FOIA.

"From Public Citizen's perspective -- we work a lot on issues relating to drug safety here -- the current provision in the House bill really threatens to undermine the public's access to information about drug safety and effectiveness. It's an issue all consumers should care about," Murray told CMD.

House Will Vote Wednesday

The bill has been placed on the suspension calendar for a vote on Wednesday. CMD has signed on to a letter to House Oversight and Government Reform Committee Chairman Fred Upton and Ranking Member Henry Waxman, asking the committee to strike the provision and preserve public access to health and safety information. The text of the letter follows:

Dear Chairman Upton and Ranking Member Waxman:

The undersigned organizations concerned with openness and accountability are writing to urge you to remove or substantially narrow a provision of H.R. 5651, the Food and Drug Administration Reform Act of 2012, that needlessly prevents the public from having access to potentially important health and safety information and that could greatly diminish the public's access to information about the work of the U.S. Food and Drug Administration (FDA).

Section 812 of H.R. 5651 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. As introduced, Section 708 of S. 3187, the Food and Drug Administration Safety and Innovation Act, contained similar language. The Senate accepted an amendment to the provision offered by Senator Leahy (D-VT) that limits the scope to information voluntarily provided by foreign governments, requires that the request to keep the information confidential be in writing, and, unless otherwise agreed upon, specifies a time frame after which the information will no longer be treated as confidential.

We understand that Congress intends the language to promote the sharing of drug inspection information by foreign governments with the FDA. However, the FDA does not need this authority because the Freedom of Information Act (FOIA) already provides exemptions to protect against the release of many law enforcement records; confidential, commercial information; and trade secrets.

At the very least, section 812 should be narrowly tailored to avoid unintentionally or unnecessarily increasing secrecy at the FDA. The provision currently covers information obtained from other federal agencies, which are themselves subject to FOIA, and information obtained from state and local agencies, despite an FDA regulation that specifically protects from disclosure many records submitted to FDA by those agencies. Furthermore, the provision is written so broadly that it could include information that now is required to be disclosed to the FDA, restricting the public's right to know about potential health and safety risks.

We urge you to address this problem before H.R. 5651 is brought to the floor for a vote and to work with the conference committee to ensure that section 812 is either removed or, at a minimum, substantially narrowed to protect the public's right to critical health and safety information. Representatives from the undersigned organizations are willing to discuss possible ways to address these issues. If you would like to discuss these issues further, please contact Patrice McDermott, Executive Director of


American Library Association
Association of Research Libraries

Center for Media and Democracy
Citizens for Responsibility and Ethics in Washington – CREW
Essential Information
Freedom of Information Center at the Missouri School of Journalism
Mississippi Center for Freedom of Information
National Coalition Against Censorship
National Freedom of Information Coalition
National Priorities Project
OMB Watch
Project On Government Oversight – POGO
Public Citizen
Sunlight Foundation
Washington Coalition for Open Government

The illustration above from Drug Discovery & Development, March 2008, appeared in this article.