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FDA to Improve Drug Safety Monitoring

February 16, 2005
Health and Human Services Secretary Mike Leavitt and Lester M. Crawford, the acting commissioner of the Food and Drug Administration have unveiled a plan that officials say will promote a culture of openness and enhanced oversight within the Agency.

COX-2 Drugs • Bextra • Celebrex • Vioxx --- News • Celebrex May Disrupt Heart Rhythm • FDA Rejects Arcoxia As Arthritis Drug • FDA Panel Rejects Vioxx Replacement • FDA Panel Members Indebted to Drug Companies • COX-2 Painkillers Restricted in Europe • Researchers Ignored Early COX-2 Warnings • FDA to Improve Drug Safety Monitoring • FDA Convenes COX-2 Meeting • FDA Blasts Ads For Celebrex, Bextra • Feds Issue Caution On All COX-2 Drugs • British Heart Patients Told to Stop Taking Cox-2 Drugs • Researchers Warn of Dangers

The move follows last September's withdrawal of the popular painkiller Vioxx and a report in The Wall Street Journal that internal Merck & Co. e-mails and documents show the company knew for years the drug posed serious risks of heart attack and stroke.

Also today, the Center for Science in the Public Interest said its review of the medical literature showed that published studies of prescription painkillers Vioxx, Celebrex, and Bextra were largely geared to developing new uses for those drugs and were much less concerned with the question of whether they increased users' risk of heart attacks and strokes,

The cornerstone of the FDA initiative is the creation of a new independent Drug Safety Oversight Board (DSB) to oversee the management of drug safety issues and provide up-to-the-minute information to health providers and patients about the risks and benefits of medicines.

The board, which will oversee the management of important drug safety issues within the Center for Drug Evaluation and Research (CDER), will include members from the FDA and medical experts from other HHS agencies and government departments (e.g., Department of Veterans Affairs) who will be appointed by the FDA Commissioner. The board also will consult with other medical experts and representatives of patient and consumer groups.

FDA will also increase the transparency of the its decision-making process by establishing new and expanding existing communication channels to provide targeted drug safety information to the public.

These channels will be used to help ensure that established and emerging drug safety data are quickly available in an easily accessible form. The increased openness will enable patients and their healthcare professionals to make better-informed decisions about individual treatment options.

As part of the effort, FDA is proposing a new "Drug Watch" Web page for emerging data and risk information and increased use of consumer-friendly information sheets written especially for healthcare professionals and patients.

As it develops these communications formats, the agency will be soliciting public input on how it should manage potential concerns associated with disseminating emerging information prior to regulatory action.

FDA will issue draft guidance on procedures and criteria for identifying drugs and information for the Drug Watch Web page. In addition, it will actively seek feedback from healthcare professionals and patients on how best to make this information available to them.

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