Drugmakers haven't made progress in starting studies that they promised to conduct after their products were approved by U.S. regulators, according to data released today. The Food and Drug Administration determined that 1,044, or 62 percent, of incomplete studies for conventional drugs and biotechnology medications had yet to be started as of Sept. 30. At the same time in 2006, 1,026, or 63 percent, of the unfinished studies hadn't begun, according to the FDA. To receive FDA approval, drugmakers often agree to perform additional studies of safety, dosing and other matters after medications come to market. The research is usually voluntary, and lawmakers have repeatedly complained it isn't completed.
Doctors say post-approval studies may be needed to fully assess the risks of medications because some dangers don't emerge until products are in widespread use. Some research has been pending for years. Of the 1,044 studies that hadn't begun, drugmakers committed before Oct. 1, 2004, to undertake 444 of them, according to the FDA. The FDA statistics show 271 studies, or 16 percent, were on or ahead of schedule, and 242, or 14 percent, had been submitted for FDA review or terminated before completion.
Bonnie - what more can you say?
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