Healthy Skepticism Library item: 8317

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Publication type: news

Studies overdue for drugs in use
Bloomberg News 2007 Feb 2
http://www.bloomberg.com/apps/news?pid=washingtonstory&sid=aNU3jba1kYIo

Full text:

Drugmakers have yet to begin more than two out of every three pending studies that they promised to do after their products were approved by U.S. regulators.

The Food and Drug Administration determined that 899, or 71 percent, of 1,259 post-approval studies hadn’t been started as of Sept. 30, according to data posted yesterday on the agency’s Web site. The numbers do not include completed studies.

To receive FDA approval, drugmakers often agree to perform additional studies of safety, dosing and other matters after medications come to market. The studies are usually voluntary, and the FDA can’t impose fines for failing to conduct them. Some consumer groups and lawmakers are pushing for legislation to give the FDA more authority over the studies.

“How can the FDA claim it is committed to improving drug safety when it can’t even get drugmakers to do the studies they promise?” said Bill Vaughan, senior policy analyst with Consumers Union in Washington, D.C., in a statement. “Should consumers really feel safe when two out of three studies aren’t being done, and the FDA doesn’t even have the authority to get them done?”

Members of Congress have criticized the FDA’s oversight of drug safety in recent years, as studies linked antidepressants to suicide risk for children and painkillers to elevated chances of heart attacks. Merck & Co. withdrew its Vioxx pain drug in 2004 after a company study showed higher cardiac and stroke risks.

Doctors say post-approval studies may be needed to fully assess the risks because some dangers don’t emerge until products are widely used.

The FDA is seeking ways to work with drugmakers to carry out the studies, agency spokeswoman Susan Cruzan said in an e-mailed response to questions. The agency also is trying to improve its ability to track and monitor the studies, she said.

Drugmakers are committed to completing the studies, said Alan Goldhammer, deputy vice president for regulatory affairs at the Pharmaceutical Research and Manufacturers of America, an industry group in Washington. Sometimes companies have difficulty finding enough patients to participate, he said.