House overhauls, passes PDUFA

Congress kicked their work on an FDA funding bill into gear--after the FDA commissioner gave them a kick in their collective pants [1]. The commissioner threatened to lay off workers if the agency didn't get its funding by tomorrow's deadline, so the House scrambled to approve a measure that would boost FDA funding and revamp its drug-safety system. The bipartisan compromise bill still awaits approval by the Senate.

The renewed PDUFA would increase the fees paid by drug and device makers when they submit products for approval. And it would boost the FDA's power to monitor drugs after they're put on the market. The agency could order companies to perform clinical trials, for instance, and could issue warnings earlier than it could before.

The bill also sets up a high-tech surveillance system to try to spot safety problems earlier, and, as expected, calls for a public-access database of all clinical trials [2]. So hold on to your pink slips, Mr. Commissioner. It looks as if you'll get your money.

- see this statement [3] from the bill's lead author, Rep. Frank Pallone (D-NJ)
- read the story [4] from the Los Angeles Times

Related Articles:
FDA: 2,000 layoffs if PDUFA not passed. Report [1]
Bickering may stall trial database. Report [2]
Congress juggles two crucial drug bills. Report [5]
PDUFA debate highlights drug safety issues. Report [6]