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FDA fails to follow up on safety of fast-tracked drug approvals

Monday, November 30, 2009 by: Paul Louis, staff writer
Tags: FDA, drug approvals, health news

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(Natural News) A new congressional report from the Government Accountability Office (GAO) reprimanded the FDA for failing to properly monitor drugs approved under the FDA's 1992 accelerated approval process. The report focused on 90 drugs.

The accelerated approval process was ostensibly enacted to rush minimally tested cancer and AIDS drugs that were urgently needed to assist those with life threatening situations. In exchange for accelerated approval by the FDA, drug manufacturers agreed to provide the FDA with post-marketing reports to determine if the drug is safe and effective.

Yet most drug makers were not complying with post marketing follow-up reports. And the FDA has never removed a drug approved by the accelerated process from the market. Some of the drugs approved have gone 13 years without post marketing reports!

The GAO report states, ". . . the FDA has authority to expedite the withdrawal of a drug from the market if a sponsor does not complete a required confirmatory study with due diligence, or if a study fails to confirm a drug's clinical benefit, [yet the FDA] has not specified the conditions that would prompt it to do so."

This indicates that the FDA has never created a procedure to remove fast track drugs even if they are dangerous. This precludes quality control on drugs fast tracked for public consumption. Pre-market proposals based on theory and limited testing have been the only basis for continued use. Therefore the public becomes part of a medical experiment.

Some drugs that never reported were big money makers for over a decade. And the FDA never bothered to inquire about their follow up reports. The GAO report requested the FDA "clarify" under what circumstances it would voluntarily remove potentially dangerous or ineffective drugs from the market.

The FDA balked. They claimed there was no need for clarification.

FDA officials asserted that these fast track drugs are ". . . life-saving drugs for which there are no replacements." Yet there is little or no documented proof of "life saving" efficacy or safety because post marketing reports have, for the most part, never been conducted.

It appears that the FDA's requirements for post market reports from drug companies in exchange for accelerated approval were window dressing. The FDA's lack of enforcement speaks for itself. Meanwhile many drug makers have made a lot of money dispensing often ineffective and sometimes dangerous drugs to desperate people.

Sources for this article include:


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