The delaly, however, doesn't appear to have triggered reduction in force notices to FDA staff. The agency had advised Congress that if PDUFA legislation wasn't enacted by July 31, it may have to send out notices of possible layoffs to staffers whose positions are funded by user fees, which are set to expire Sept. 30. Notices must be sent 60 days in advance.
The agency hasn't notified the National Treasury Employees Union of a possible reduction in force, or RIF, which is a prerequisite to the notices. "NTEU has not received notification of any RIFs" stemming from the user fee program, National President Colleen Kelley told the newsletter. As an alternative to an RIF, if needed, FDA could furlough agency employees - an action that does not always require pre-notification, the Pink Sheet wries..
Before the child health bill seized policymakers' attention, staff level discussion on FDA reform was quite productive, according to House and Senate aides. One issue that continues to be thorny is establishment of a procedure for approval of follow-on biologics, a matter addressed in the Senate bill but not the House version.