Drug testing follow-up lacking
Bamberger Health and Wellness -- Everett and Lynnwood, WA -- (425) 355-4176
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Drug testing follow-up lacking Bamberger Health and Wellness -- Everett and Lynnwood, WA -- (425) 355-4176
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Drug firms don't do FDA-required studies, group charges - Federal health officials require drug companies to perform studies on new medicines after they hit the market, but most are never done, a U.S. consumer group charged on Thursday. Often when the Food and Drug Administration (FDA) approves a drug, it orders the manufacturer to conduct further studies of side effects or how well it works for certain patients. But only 13% of the 88 follow-up studies required for drugs launched in the early 1990s were completed, according to a report by Public Citizen. No studies were finished for 107 drugs that went on the market between January 1995 and last December, the group said. An FDA official said the figures, from agency records that Public Citizen obtained through the Freedom of Information Act, were incomplete. She said the agency was working to gather exact numbers and make them public. Dr. Sidney Wolfe, head of Public Citizen's Health Research Group, said the apparent neglect of the studies may mean that side effects go undetected. The FDA monitors drug reactions but its system has limitations and would benefit from added information, he said. The FDA's drug review process came under scrutiny after manufacturers agreed last month to stop marketing two drugs, Warner-Lambert Co.'s Rezulin for diabetes and Johnson & Johnson's Propulsid for heartburn. - Reuters Health, April 14, 2000
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