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Dangerous drugs

US Senators introduce legislation to force drug companies to complete post-approval studies

Thursday, July 20, 2006 by: NewsTarget
Tags: dangerous drugs, the FDA, public safety


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(NewsTarget) A bill proposed by Sens. Mike Enzi, R-Wyo., and Edward Kennedy, D-Mass., would subject drug companies to harsh fines if they fail to complete post-approval studies or violate proposed safety-monitoring plans after FDA approval of a product.

Enzi, the chair of the Senate Health, Education, Labor and Pensions Committee, and Kennedy, the leading democrat on the panel, drafted the legislation to bolster the FDA's regulation of medicines and their safety before they are marketed. They hope to have a final version of the bill before congress prior to its summer recess in August.

The legislation comes on the heels of a similar bill favored by Senate Finance Committee Chairman Charles Grassley, R-Iowa, which would establish an office tasked with approving drugs for sale completely separate from the FDA.

In the past, the FDA has failed to enforce measures such as post-approval studies, encouraging some drug companies to simply ignore the requirement altogether -- the most famous consequence of which is 2004's Vioxx scandal. The FDA came under heavy fire for its mismanagement of the arthritis pill, which was withdrawn by maker Merck & Co Inc. after it was linked to heart attacks and strokes.

Under Enzi and Kennedy's new bill, the FDA would be required to work with drug makers to set strategies and manage risks after a product had been released, and outline deadlines and a process to resolve disputes if either party fails to agree on a plan. The companies would then be required to publish the results of early, late-stage and post-approval studies in a public database. Finally, the companies would meet with the FDA and review the plans once a year for the first three years after a drug is approved and marketed.

The bill would also authorize the FDA to impose fines, ranging from $15,000 to $250,000, on any drug maker that ignores the guidelines.

In response to the legislation, FDA critic Mike Adams responded, "That the legislature has to pass laws to force the FDA to do its job is, indeed, a sad statement on how completely the Food and Drug Administration has failed the American people."

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