House passes PDUFA, preventing pinkslips (for now)
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Important news for those going through the FDA drug-approval process: the renewal of the Prescription Drug User Fee Act (PDUFA) cleared a major hurdle late last week when the U.S. House of Representatives passed the bill. All that remains now is for it to be passed by the Senate and signed by the President before the Friday deadline. The pressure to resolve the issue increased considerably when FDA Commissioner Andrew von Eschenbach sent out a memo warning that 2,000 workers could get pink slips if Congress doesn’t renew the act by Friday’s deadline (Wall Street Journal, subscription required). As has been their custom recently, the Democrats blinked when faced with another game of chicken.
From the 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, money for studies of older medicines, incentives for tests in children and even the conflicts of interest of drug agency advisers.
However, the bill did not become the “Christmas Tree” that many industry insiders had feared. The bill does not address access to unapproved drugs by severely ill patients nor does it touch biosimilars issue.
A great source for this story, as always, Fierce Biotech
- see BIO’s reaction to the bill
- read the New York Times article from Sept 20th: “FDA Commissioner Warns
Employees of Possible Layoffs”
Kevin currently manages initial client engagements with the MaRS Venture Group. He also administers a federal fund that provides mentorship to start-up companies across Ontario.