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Lester M. Crawford, Acting Commissioner of the FDA, defends the FDA's position that it is using sound judgment and good science when dealing with drug safety. He states that the FDA has called for a study by the Institute of Medicine on whether changes are needed in regard to the post-market drug surveillance program by saying the FDA's Office of Drug Safety is independent from the office that reviews new drug applications, the Office of New Drugs. If you enjoy this article, you may also be interested in an article entitled 'With COX-2 decision, no longer any doubt about FDA corruption and U.S. drug racket.'

Overview:

* The Food and Drug Administration takes drug safety and risks seriously and will continue its longstanding practice of assessing the safety of drugs using sound judgment and good science --- including peer-reviewed analyses.

* As one of the world's premier public health agencies, we thrive on scientific discourse.

* Indeed, one of FDA's true strengths is its ability to analyze a broad range of complex data and perspectives and reach consensus on a course of action, while reconciling conflicting views.

* While it is critical for FDA to be certain that each valid scientific point of view is considered, the public trust requires that, ultimately, FDA make the best possible decision for public health.

* FDA's drug review process --- among the world's most stringent --- evaluates the safety and effectiveness of each drug before it is approved for marketing, and continually evaluates reported adverse events to assess whether unforeseen safety concerns need to be addressed.

* Some have called for more independence for the FDA's post-market surveillance program.

* The agency has requested that the prestigious Institute of Medicine conduct a broad study and make recommendations on whether such changes are needed.

* But it is important to keep in mind that the FDA's Office of Drug Safety, in the Center for Drug Evaluation and Research, is already an independent office separate from the Office of New Drugs, the office that reviews new drug applications.

* Further separating this office from the rest of the Center for Drug Evaluation and Research might jeopardize the close collaboration that helps ensure that all critical data are readily factored into the risk-benefit equations used to assess the public health implications of any drug.

* Lester M. Crawford is acting commissioner of the U.S. Food and Drug Administration.

Source: http://www.usatoday.com/news/opinion/2004-11-21-drug-safety-oppose_x.htm

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