An Agreement Has Been Reached – House and Senate Staff Negotiators Release “Staff Agreement” on Omnibus FDA Reform Legislation; a Vote is Expected Soon

House and Senate staff have reportedly reached an agreement on omnibus FDA reform legislation that would, among several other things, reauthorize the Prescription Drug User Fee Act (“PDUFA”) through fiscal year 2012.  Earlier today, a “staff agreement” (427 pages) and summary of the legislation was released.  As was widely expected, the bill does not contain any provisions concerning biogenerics (a topic that might be addressed in future legislation).  Late last week, FDA Commissioner Andrew von Eshhenbach sent a letter to Senator Michael Enzi (R-WY), Ranking Member of the Senate Health, Education, Labor and Pensions Committee, warning that unless the reauthorization of PDUFA could be ensured by September 21, 2007, “this will unfortunately lead to FDA beginning to issue reduction-in-force (RIF) notifications to employees that funding for their positions will expire.”  That crisis has apparently been averted.  The House may vote on the conference bill later today, and the Senate may vote on the measure tomorrow. 

We will continue to update you with additional information, and will provide FDA Law Blog readers with an in-depth summary of the legislation once the bill is signed into law.

UPDATE:

• The House passed H.R. 3580, the FDA Amendments Act of 2007, around 4:00PM today by a vote of 405-7.  A copy of the version of the bill passed by the House is available here (422 pages).  A revised summary is available here.  It appears that the new version omits certain provisions included in Sec. 1111 of the “staff agreement” above related to so-called “old” antibiotics.
• The official version of H.R. 3580 is available here.