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FDA Holds Back Information on 9 of the 25 Most Prescribed Drugs

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By The Sunlight Foundation Reporting Group

When your doctor makes a decision about which popular prescription drug to give you—whether you’re suffering from high cholesterol, asthma, ulcers, or some other common ailment—it’s quite likely that he or she lacks easy access to basic research data about the drug.

A review by the Sunlight Foundation found that safety and efficacy information analyzed as part of the federal drug approval process is not available online for nine out of the top 25 prescribed brand name pharmaceuticals in the United States—popular drugs such as Lipitor, Plavix, and Synthroid. Of those reviews that are made available on-line, the great majority were approved after 1997.

The U.S. Food and Drug Administration (FDA) Web site makes drug approval background documents available online only for drugs that were approved from 1998 on, according to spokesperson Sandy Walsh. Some information for drugs approved in 1997 or earlier is online, but only if someone—a researcher, a physician, a citizen, a journalist—made a formal Freedom of Information Act (FOIA) request for the information. Even then, in some cases the agency does not plan to post older information on-line because of the poor quality of some of the preserved documents.

That still leaves approval information on many popular drugs that treat common conditions behind closed doors. Researchers or consumers interested in obtaining this information must file Freedom of Information Act (FOIA) requests and wait for weeks or months to receive the information.

It’s unclear whether such information would be affected by the Obama Administration’s new Open Government Directive, which asks agencies to identify and publish at least three high value datasets not yet available on-line at Data.gov and also develop an open government plan—essentially, a plan to release other public data—in about six months. But proponents of more transparency in the pharmaceutical industry argue that such data should be a prime candidate for release.

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The Sunlight Foundation Reporting Group is part of the Sunlight Foundation, a nonprofit, nonpartisan Washington, D.C.-based organization that uses cutting-edge technology and ideas to make government transparent and accountable.


Source: http://reporting.sunlightfoundation.com/2010/fda-holds-back/


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