DRUG STUDIES: WHY THE DELAY?

Pharmacy Times, Volume 0, 0

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

According to data posted on the agency's Website, 899 of 1259 postapproval studies had notstarted as of September 30, 2006. The figures donot reflect completed studies.

To receive FDA approval, drugmakers oftentimesagree to perform additional studies of safety,dosing, and other issues after medicationsenter the marketplace. The studies are usually voluntary,and the agency cannot enforce fines forfailing to conduct them.

Consumer groups and some lawmakers areurging legislation to give the FDA more authorityover the studies.

The newly released FDA statistics indicated that184 studies were on or ahead of schedule, and144 had been submitted for agency review or terminated.Some of the studies—about 31—werelabeled "delayed."