PDUFA Legislation Has Expired

Theoretically, as of October 1, the US Prescription Drug User Fee Acthas expired. However, the Food and Drug Administration has already said that it has enough in PDUFA carry-over funds - $24 million or $28 million - to keep the 600 new drug reviewers hired as a result of PDUFA working for another three to four months.

Given the available funds, it is unlikely that the FDA will have to issue the mandatory 90-day notices of possible termination until about November 1, by which time Congress should have completed its work on the FDA modernization/PDUFA reauthorization bills.

The momentum is still there for this legislation, a spokesman for the Pharmaceutical Research and Manufacturers of America told the Marketletter, adding that the carry-over funds will give Congress the time it needs to pass this legislation.