Drugmakers: Prepare for a Smackdown

The FDA plans to lay heavier regulations on Big Pharma.

For years the Food and Drug Administration has failed to adequately monitor the pharmaceutical industry. That conclusion by a special committee at the Institute of Medicine in a September 2006 report titled “The Future of Drug Safety” helped prompt a sweeping reform bill that became law last September. The Food and Drug Administration Amendments Act of 2007 gives the FDA the dollars and legal clout it needs to make a number of important fixes. Its key provisions and other new initiatives include these:

• The FDA will hire 1,300 new employees, with at least 400 dedicated to drug review.

• The agency has earmarked money for the development of a network of organizations to monitor the safety of FDA-approved drugs. Assembled and led by the FDA, the network participants—which include health-care insurers and providers—will have the ability to search millions of their own database records at the agency’s request. This surveillance system is built to identify problems, such as side effects of pharmaceuticals and medical therapies, as they emerge.

• All clinical trials of every FDA-approved drug must be registered on an NIH Web site, with results of those trials also posted.

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