This appears to be the new goal for Congress to complete action on PDUFA and safety reforms,
The Pink Sheet reports (subscription required). Efforts to resolve differences between the House and Senate versions are being sidetracked by a decision in both chambers to focus on passing the child health insurance program bill before Congress adjourns Aug. 2 for summer recess, staffers indicated.
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.
2 Comments
Ed, With regard to PDUFA and Conflicts of Interests let me add something I came across regarding Provenge, and Dr. Howard Scher's affiliation with ProQuest Investments, a $1 billion venture capital fund, and PCF, Michael Milken's Prostate Cancer Foundation. Interestingly, Jonathan W. Simons, M.D., chief executive officer and president of the PCF is also 1 of 7 scientific advisors to ProQuest Investments. Interestingly, this notable appointment is lacking this bit of information on Dr. Simons ProQuest bio.
http://www.prostatecancerfoundation.org/site/c.itIWK2OSG/b.2177291/k.5933/Top_Cancer_PhysicianScientist_Named_New_Head_of_the_Prostate_Cancer_Foundation.htm
http://www.proquestvc.com/scienceadvisory.asp
Dr. Howard Scher is one of eleven PCF consortium members and is 1 of 7 scienfic advisors to ProQuest Investments.
PCF sure has a strong relationship to venture capital. How truly independent and benevolent is PCF? How much influence do they have over the FDA? Do you consider any ammendments to the PDUFA, similar to the Durbin Amendment, likely?
[...] Ed Silverman at Pharmalot updates us on what’s happening with prescription drug legislation. [...]