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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.


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