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FDA Drug Safety Overhaul Bill Passed by Senate To Change the Way Agency Handles Defective Drugs

Sep 21, 2007 | Parker Waichman LLP, LLP

The Food & Drug Administration (FDA) is poised to change the way it monitors drug safety, following Senate passage of a bill that gives the agency more power to police medications already on the market.   The legislation, which was approved by the House on Wednesday and is expected to be signed by President Bush, would make the FDA much less dependent on the drug industry for safety information, and gives the agency more power to take action against defective drugs.

Consumer advocates are praising the new bill, which requires the FDA to take a more active role in monitoring the safety of drugs once they are approved and on the market.  Defective drugs are estimated to kill 15,000 people every year.  Under the current law, the FDA approves new drugs after they have been tested on just a few thousand people.  Then, the agency waits to see if the approved drug causes any problems. And often, the FDA must rely on pharmaceutical companies to bring safety issues to its attention.  As a result, dangerous side effects sometimes go unnoticed for years before the FDA does anything about a defective drug.

This approach has not worked well.  According to an analysis of FDA records, the agency received 90,000 reports of drug side effects in 2005.   About 15,000 of those resulted in death, and more than 5,000 others caused serious disability.  And in the past several years, the FDA has been rocked by scandals involving approved drugs like Vioxx and Avandia, which were shown to have dangerous side effects after they went on the market.   What’s worse, in the cases of Avandia and Vioxx, evidence came to light indicating that that the FDA had knowledge of safety issues long before they became public.

The new law requires the FDA to set up a new computerized system to scan pharmacy and insurance records for patterns of problems with medications.   For instance, the database could be used to compare patients taking a newly approved medication and those using an older drug for the same ailment.  If the patients taking the newer drug start having problems, the FDA would know sooner.  The legislation also give the FDA authority to require drug makers to conduct new studies and clinical trials on marketed medications should disturbing patterns develop in relation to a medication.  The agency also will have greater authority to demand changes to drug labels and prescribing information.

Other provisions of the legislation would require more transparency in the way the FDA makes decisions, and it would require more complete disclosures of clinical research.   It also would reduce the FDA’s reliance on outside advisors with financial ties to the drug industry, and create a new program to monitor drug advertising.

The new bill, if signed by President Bush, will offer consumers improved protection from defective drugs.   But expectations should not be too high for the immediate future, as the new drug safety system will take years to implement.   For example, under the law, the FDA is not required to have the new drug database fully functional until 2012.  Until then, many experts agree that Americans will have to endure more drug safety scares.


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