DRUG STUDIES: WHY THE DELAY?

MARCH 01, 2007

Drugmakers are not keeping their promises. They have yet to start more than 2 of every 3 pending studies they said they would conduct after their products received FDA approval.

According to data posted on the agency's Web site, 899 of 1259 postapproval studies had not started as of September 30, 2006. The figures do not reflect completed studies.

To receive FDA approval, drugmakers oftentimes agree to perform additional studies of safety, dosing, and other issues after medications enter the marketplace. The studies are usually voluntary, and the agency cannot enforce fines for failing to conduct them.

Consumer groups and some lawmakers are urging legislation to give the FDA more authority over the studies.

The newly released FDA statistics indicated that 184 studies were on or ahead of schedule, and 144 had been submitted for agency review or terminated. Some of the studies—about 31—were labeled "delayed."




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