New generic drugs facing longer waits for approval
Published 4:00 am Saturday, February 20, 2010
NAPLES, Fla. — American consumers are waiting nearly a year longer for government regulators to approve new lower-priced generic drugs than they did in 2005.
The delays, caused by a growing backlog of applications at the Food and Drug Administration, may be costing consumers and the federal government hundreds of millions of dollars a year as they continue in some cases to pay for name-brand drugs even after their patents expire, industry analysts said.
“It’s a real problem,” FDA Commissioner Margaret Hamburg told an audience this week at the annual meeting here of the Generic Pharmaceutical Association. “I don’t pretend to believe that the status quo is acceptable.”
Saying the FDA’s generic drugs department was underfunded, Hamburg noted a potential remedy: placing application fees on companies seeking approval for generic drugs.
Five years ago, the FDA typically approved a new generic drug within 16.3 months of the application’s filing, according to a report from the agency Tuesday. But by last year, with limited staff to review an increasing number of applications, approvals for new generic drugs were taking 26.7 months, the report said.
Generic drugs account for more than 70 percent of prescriptions filled in the United States. The generics industry has saved consumers nearly $750 billion over the past decade, Hamburg said at the conference.