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FDA's New Attitude About Drug Safety Questioned

The recent release of numbers on the FDA's performance over the past year does little to support the FDA's announced new attitude about drug safety. The FDA is in need of major changes in the premarket testing and postmarket monitoring of drugs.
    SANTA BARBARA, CA, January 12, 2010 /24-7PressRelease/ -- The recent release of numbers on the FDA's performance over the past year does little to support the FDA's announced new attitude about drug safety, claims legal expert, Terence Mix. Last August, new FDA commissioner Margaret Hamburg promised that the agency would speed up and expand its issuance of warning letters to drug companies that do not follow FDA regulations.

"The agency must show industry and consumers that we are on the job," Ms. Hamburg was quoted. "Companies must have a realistic expectation that if they are crossing the line, they will be caught." But Mix states that the FDA added only 31 of the strong "black box" warnings on drug labels during 2009 compared to 56 the year before. "That's a drop of 45%," says Mix, "and hardly reassuring that the FDA is holding industry to a higher standard of accountability."

Mix points to studies that have shown that well over 50% of all drugs entering the market have serious side effects that are not revealed in premarket testing prior to approval. "That makes us all guinea pigs for the drug industry," he states. "Every year, 2.3 million Americans spend time in the hospital and 230,000 die as a consequence of an adverse reaction to prescription and nonprescription drugs, including 105,000 who die while taking the drugs exactly as specified by the drug companies." He adds that the health care costs due to drug reactions exceed $200 billion per year.

"Until we cease allowing drug companies to control the very studies that determine whether their drugs are approved for marketing, and make other major changes at the FDA on how drugs are tested and monitored, this insanity will continue," says Mix. He states that his forthcoming book, "The American Guinea Pig," will not only detail all of the multiple problems with the current system, but lay out a plan on how these tragic statistics can be cut in half.

Terence Mix is an attorney/author who writes about reform of the FDA and drug industry. For additional information, please contact him at (805) 681-1401 or (805) 452-6643.


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Terence Mix
Terence Mix

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