House passes PDUFA: bill heads to Senate

The U.S. House of Representatives has passed a bill to renew the Prescription Drug User Fee Act (PDUFA), positioning it to be passed by the Senate and signed by the President before the Friday deadline. The PDUFA has to be renewed every five years. Recently FDA Commissioner Andrew von Eschenbach (photo [1]) sent out a memo warning that 2,000 workers could get pink slips if Congress doesn't renew the act by Friday's deadline.

According to The New York Times, "The bill combined several pieces of legislation governing drug industry user fees, new rules involving the disclosure of clinical trial results [2], money for studies of older medicines, incentives for tests in children and even the conflicts of interest of drug agency advisers." There were, however several highly-debated issues that didn't make it into the bill. Many patient advocacy groups want the FDA to allow severely ill patients to have access to unapproved drugs [3]; the bill passed yesterday doesn't address these concerns. And as anticipated, legislation that would pave the way for biosimilars was not part of the bill [4]--much to the relief of branded drugmakers everywhere.

- see BIO's reaction [5] to the bill
- read the New York Times article [6]

Related Articles:
FDA: 2,000 layoffs if PDUFA not passed. Report [7]
Bickering may stall trial database. Report [8]
Congress juggles two crucial drug bills. Report [9]
PDUFA debate highlights drug safety issues. Report [2]