PDUFA reauthorization expected this week
PDUFA Reauthorization: Almost There
As Motley Fool and others are reporting, we can expect to see the 2007 bill reauthorizing the Precription Drug User Fee to emerge from conference committee this week, as FDA will give notices of layoffs to 2,000 employees on Sept. 21 without the legislation passing both houses and being signed into law by the president. Conference committee sessions are closed to the public. Congressional aides have been reporting that language providing a pathway for FDA approval of biosimilars aka biogenerics has been removed from consideration of the PDUFA legislation but could be debated as part of stand-alone legislation later this year.
I will report on the contents of the proposed PDUFA legislation as it is made public. It’s fair to assume that morale and workflow are being disrupted within FDA while it awaits word on the bill. It’s also fair to assume that such distractions are not good for sponsors.
