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 studiesabout 31were labeled "delayed."
The Oncology Care Pharmacist in Health-System Pharmacy
According to the National Cancer Institute, almost 40% of men and women will be given a diagnosis of some form of cancer in their lifetime.
News from the year's biggest meetings
Clinical features with downloadable PDFs