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After Being Pressured, FDA Posts Committee Materials on Web Well in Advance of Hearing

May 21, 2001

After Being Pressured, FDA Posts Committee Materials on Web Well in Advance of Hearing

Documents Show Corporate Damage Control Efforts on Blood Pressure Drug

WASHINGTON, D.C. ? After being pressured for years to increase the public?s access to documents distributed to Food and Drug Administration (FDA) advisory committees before members convene, the FDA has posted materials on the Internet a full eight days prior to a key May meeting.

Public Citizen in January 1999 sued the FDA under the Freedom of Information Act and the Federal Advisory Committee Act to require the agency to make available to the public ? prior to the meetings ? the same materials distributed to advisory committee members. The suit was settled in January 2000, when the FDA agreed to make committee briefing materials available to the public 24 hours before meetings.

Making such information available is crucial because drug companies have the ability to tightly manage information about their products. The briefing materials are often the only objective sources of information about drug safety and effectiveness available to the public.

.Usually, the FDA has conformed to the 24-hour limit. But on May 15, the agency posted on its Web site materials distributed to the Cardiovascular and Renal Drug Advisory Committee, which is scheduled to meet May 24. The committee that day will consider a citizen petition concerning the safety of the high blood pressure drug, Cardura.

The briefing materials can be found at http://www.fda.gov/ohrms/dockets/ac/cder01.htm#Cardiovasular and Renal. The citizen petition and documentation showing corporate damage control efforts to stonewall about problems with Cardura are located at https://www.citizen.org/sites/default/files/cp00001.pdf.

“We are pleased that the FDA is posting these valuable documents further in advance of the committee meeting than 24 hours,” said Dr. Sidney Wolfe, director of Public Citizen?s Health Research Group. “We hope the agency will continue to make this kind of information available to the public in as timely a fashion as possible, preferably at the same time as advisory committee members receive them.”