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. 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. So hold on to your pink slips, Mr. Commissioner. It looks as if you'll get your money.

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

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

Suggested Articles

Post-Tesaro buyout, don’t expect GlaxoSmithKline to spring for more commercial-stage oncology products anytime soon.

Already a fast-growing blockbuster, Novo Nordisk's injectable Ozempic won a major heart-helping FDA nod that could bode well for its oral sibling.

Bayer's new Vitrakvi for tumors with NTRK gene fusions is meeting skepticism in England and Germany, where cost watchdogs on Friday rejected it.