|FDA reports that many clinical trials are not being undertaken. Source: Minneapolis Public Radio|
Pharmaceutical companies have been remiss in beginning clinical studies that they have agreed to conduct after their products were approved by U.S. regulators, according to FDA data.
The FDA has determined that as of Sept. 30, 2007, 1,044 (62 percent) of studies for conventional drugs and biotechnology medications had yet to be started. In 2006, 1,026, or 63 percent, of the studies had not begun.
To receive FDA approval, pharma companies often agree to perform additional studies of safety, dosing and other matters after medications come to market, according to Bloomberg. The research is usually voluntary and lawmakers have repeatedly reported on its failure to be completed.
In September 2007, President George W. Bush signed legislation, allowing the FDA to require certain post-approval studies.
“Drugs often come on the market with an expectation that studies will be conducted,” said Peter Lurie, deputy director of the Health Research Group in Washington, D.C.-based Public Citizen, an advocacy organization, told Bloomberg. “In fact, many of these studies begin late or do not begin at all.”
Physicians report that post-approval studies may be needed to fully assess the risks of medications because some dangers do not emerge until products are in widespread use, Bloomberg reported.
Some of the uninitiated studies are long-standing delays. Of the 1,044 studies that had not been started, drugmakers committed to undertake 444 of them before Oct. 1, 2004, according to FDA data.
The FDA statistics also showed that 271 studies (16 percent) were on or ahead of schedule, and 242 (14 percent) had been submitted for FDA review or terminated before completion. The FDA described 125 studies as “delayed.”
However, many U.S. studies do not currently have deadlines imposed by the FDA.
The FDA is considering how to integrate its new power to require studies with commitments that have been made by drugmakers, FDA spokeswoman Susan Cruzan told Bloomberg.