Drugmakers haven't made progress in starting studies that they promised to conduct after their products were approved by U.S. regulators, according to newly released FDA data. The agency determined that 1,044, or 62 percent, of incomplete studies for drugs and biotechs 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,Bloomberg News reports.
To receive FDA approval, drugmakers often agree to perform additional studies of safety, dosing and other matters after meds come to market. The research is usually voluntary, and lawmakers have repeatedly complained it isn't completed. President Bush signed legislation in September that allows the FDA to require certain post-approval studies.
Meanwhile, 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. The stats 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. The FDA described 125 studies as "delayed.'' The FDA report didn't identify specific companies or the number of drugs covered by the studies. Drugmakers sometimes agree to complete multiple studies for a single product.
Not all of the uninitiated studies are considered late by the FDA. Many don't have deadlines imposed by regulators. The FDA is considering how to "integrate'' its new power to require studies with commitments that have been made by drugmakers, agency spokeswoman Susan Cruzan wrote Bloomberg. The FDA will work to ensure that studies previously promised "are completed in a timely manner."