Senate Passes Omnibus FDA Reform Legislation

September 20, 2007

Late today, the U.S. Senate passed FDA reform legislation by unanimous consent.  The Senate vote follows the House’s action yesterday when it passed H.R. 3580, the FDA Amendments Act of 2007. 

Earlier in the day there was some concern that the Senate vote on the House bill might be delayed.  Multiple Senators reportedly placed “holds” on the bill due to frustration on how differences between the House and Senate versions of the legislation were hammered out.  Once the holds were dropped, the Senate passed the legislation.

Now that the bill has passed both legislative chambers, it will go to the President for his signature to become law.  Although the Bush Administration had previously expressed concerns about certain aspects of FDA reform legislation (i.e., biogenerics and importation) in a Statement of Administration Policy, these provisions are not in H.R. 3580.  As such, we anticipate that the President will sign the bill into law.

FDA has not yet issued final recommendations for the fourth iteration of the Prescription Drug User Fee Act (“PDUFA IV”).  Presumably the draft PDUFA IV recommendations issued in March 2007 will be very similar to the final version.  In the draft document, FDA proposed changes to the then-proposed legislation (S. 1082), and provided letters detailing the Agency’s review performance goals for fiscal years 2008 through 2012 and performance goals and procedures for direct-to-consumer television advertising over the same five-year period.

As we noted yesterday, 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.