FDA's Galson Issues Statement on Drug Safety Hearing

Main Category: Hearing / Deafness
Article Date: 20 Nov 2004 - 4:00 PDT


Statement by Dr Steven Galson, Acting Director, Center for Drug Evaluation and Research (CDER), Regarding November 18, 2004, Committee on Finance of the U.S. Senate Hearing on Drug Safety and the Worldwide Withdrawal by Merck & Co., Inc., of Vioxx

Dr. Graham's congressional testimony does not reflect the views of the Agency. The five specific drugs that Dr. Graham identified in his oral testimony are currently approved as safe and effective for use in the United States.

The FDA evaluates the safety and effectiveness of all drugs independently on a case-by-case basis before they are approved to enter the marketplace and also evaluates reported adverse events with all drugs already on the market to assess whether unforeseen safety concerns need to be addressed. FDA takes all allegations of safety risks seriously and will continue its longstanding practice of assessing the safety of all drugs using only sound science and peer-reviewed analysis and literature.

To clarify some additional misperceptions that may have arisen, FDA's Office of Drug Safety (ODS), in the Center for Drug Evaluation and Research (CDER), is already an independent office separate from the Office of New Drugs, the office that reviews new drug applications. Both the Office of New Drugs and the Office of Drug Safety report directly to me as the Director of the Center.

The Office of Drug Safety has strong support within both the Center and the Agency and has been a vital part of FDA's efforts to assure drug safety. Although FDA medical officers and scientists in the review divisions routinely consult ODS on scientific issues, as was the case with SSRIs, and hundreds of other issues, the pre-market review divisions in CDER do not control the work of ODS.

ODS has independent authority to perform its own research and does so every day. To be valuable, this independent research must conform to widely accepted scientific standards and normal scientific procedures and peer review should not be bypassed. And when drug safety issues are identified, they must be factored into the risk-benefit equation so that safe and effective drugs remain available to patients who need them.

FDA is always open to ideas to make its post-market surveillance program even better. In fact, we recently asked the Institute of Medicine (IOM) to look at the structure of our post-marketing surveillance program and to give FDA their expert advice on whether additional changes are needed to the agency's approach to drug safety, which could include recommendations for changes in the Center's organizational structure.

We look forward to a continued open dialogue with the public, Congress, other experts in drug safety and will continue to work hard everyday to ensure that American's have access to safe and effective medications.

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