Data suggests FDA approving drugs despite delayed studies

4/24/2008

WASHINGTON Almost two-thirds of the time, pharmaceutical manufacturers are not even beginning studies that they promised to the Food and Drug Administration upon receiving approval for their drugs, according to Bloomberg. To receive FDA approval, drugmakers often agree to perform additional studies of safety, dosing and other matters after medications come to the market. The research is usually voluntary.

The data released yesterday showed that 1,044, or 62 percent, of incomplete studies for both biotech and conventional medications had yet to begin as of Sept. 30. This is an increase compared to the 1,026 studies that had not begun by the same date in 2006.

“Drugs often come on the market with an expectation that studies will be conducted,” said Peter Lurie, deputy director of the Health Research Group at Public Citizen, an advocacy organization. “In fact, many of these studies begin late or do not begin at all.”

Doctors say post-approval studies may be needed to fully assess the risks of medications because some dangers don’t emerge until products are in widespread use.

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, according to the FDA.

The FDA statistics 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 does not consider all of the uninitiated studies late. Many of them don’t have deadlines, at least not ones imposed by regulators. The agency didn’t specify the number of drugs covered by the studies. Drugmakers sometimes agree to complete multiple studies for a single product.

X
This ad will auto-close in 10 seconds