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John Bisnar
John Bisnar
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FDA Tightened Approval Process Since Vioxx Debacle

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Apparently, the Food and Drug Administration is getting very picky about the drugs it approves after the Vioxx debacle. As it should be. The nations health depends upon their expertise.

According to a news report by George E. Jordan for Newhouse News Service, FDA has approved only 17 new drugs last year, which is a new low since the peak of 53 approvals a decade ago.

“That compares with 36 approvals the year Merck pulled the painkiller from the market and an average of 28 new drug approvals annually in the years before Vioxx,” the article says.

That said, Merck was the only drug maker to win FDA approvals of two compounds – Zolinza for cancer therapy and diabetes pill Januvia.

According to the article, industry observers say the low number of approvals is because FDA has tightened the reins since the Vioxx debacle.

In my opinion, FDA should not forget the Vioxx scandal and should be taking some responsibility for the quarter million deaths attributed to Vioxx. We each bear the responsibilities for the decisions we make and our work product. So far the FDA has failed to take any responsibility but apparently has changed its ways.

Merck obtained FDA approval for Vioxx, a non-steroidal anti-inflammatory prescription arthritis drug, in approximately April 1999 through a New Drug Application on a fast-track, 6-month approval process. Merck began distribution and sale of Vioxx throughout the United States in approximately May 1999. Despite knowledge in its clinical trials and post-marketing reports associating Vioxx with hypertension and/or hypertension-related adverse health effects, Merck marketed and promoted Vioxx as safe and effective for persons with hypertension, or persons who had risk factors for stroke or cardiac problems.

This is inexcusable, unethical business practice and we at Bisnar|Chase stand ready to hold these wrongdoers accountable for the harm they have caused. We have over fifty Vioxx victims’ waiting for their trial.

The FDA must question the practices of these drug makers and hold them to the highest standards. That is what we expect when a drug is advertised as “FDA Approved”. The FDA’s approval is not do be sold to drug makers for FDA operating funds or be traded by FDA employees for a cushy job with a drug maker the following year.

If you or a loved one has suffered the effects of a defective drug such as Vioxx, call us for a free consultation.