Published Online: Thursday, March 1, 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."

Latest Articles
Beverly Schaefer, RPh, of Katterman's Sand Point Pharmacy in Seattle, Washington, shares some fun tips on how to encourage patients who travel to come to your pharmacy for supplies.
Donnie Calhoun, RPh, PD, National Community Pharmacists Association (NCPA) Foundation vice president, discusses how pharmacists can prepare themselves and their business before, during, and after a disaster.
Ken Whittemore Jr, Surescript's senior vice president of professional and regulatory affairs, talks about some new transactions available that can help pharmacists.
In case you got caught up in the Thanksgiving holiday rush, here are the top trending stories you may have missed in November:
Latest Issues