PDUFA debate highlights drug safety issues

The House is expected to take up PDUFA legislation soon, and that has renewed the debate over the impact of the fees and the possibility of new requirements related to pharmacovigilance. PDUFA, which has to be reauthorized every five years, has been a hot topic of late. Critics maintain that PDUFA has given the drug industry too much influence at the FDA, which is seeking an $87 million boost in the amount of money it brings in from the fees. But The Washington Post notes that the way the legislation is being molded in Congress, reauthorization this year seems highly likely. The industry has been largely satisfied with the way PDUFA, originally passed in 1992, has helped speed the drug review process.

New reports, though, have helped fuel the debate. One study shows that biopharma has profited considerably from faster approval times, but another researcher has linked faster approvals to greater safety troubles. Both of those topics will be front and center in the debate that's coming.

- read the article on PDUFA reauthorization from The Washington Post

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Senate toughens drug safety supervision in PDUFA bill. Report
FDA, drug industry re-negotiate user fees. Report
Congress juggles two crucial drug bills. Report
FDA critics offer data on "cozy" industry ties. Report

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