The Food and Drug Administration Reauthorization Act (FDARA) would, among other provisions, reauthorize the vital authority for FDA to collect user fees from the makers of prescription brand drugs, medical devices, generic drugs, and biosimilars.
The current user fee agreements are set to expire on September 30, 2017. These agreements, including the fees that help supplement the Food and Drug Administration (FDA), play an imperative role in the timely review of new product applications.
This is non-controversial, bipartisan legislation that needs to be acted upon. We applaud the House of Representatives for passing the FDARA by a voice vote earlier today. While we are encouraged by such action in the House, Senate action remains uncertain.
In June, the Senate HELP Committee voted almost unanimously to move the bipartisan bill forward and the Chairman and Ranking Member of the Committee are committed to ensuring timely passage, but the bill has yet to secure a scheduled vote on the Senate floor prior to the recess.
A lapse in authorization of these programs would be devastating for patients, as they may not get timely access to true breakthrough therapies. Prescription drug user fees, collected under the authority of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BSUFA), comprise nearly 70% of FDA’s resources for the review of applications for approval of new drugs and biologics, and of biosimilars. Failure to renew these programs in a timely way will result in the immediate loss of this essential revenue.
The impact of this loss of nearly three-quarters of the funds used for review will result in reviewers being laid off and applications not being reviewed. Today, user fees support nearly all of the FDA medical and scientific staff who review applications, and with this large number of reviewers, FDA is able regularly and consistently to meet the goal of completing its review in no more than 12 months from application submission. This is literally impossible without user fees.
Promising new drugs and biologics, exciting new gene therapies, cures for debilitating infectious diseases, life-extending cancer therapies – approval on all of these will be forced to wait until FDA has time and is able, with less than 1/3 of its staff and its resources, to complete them. Biosimilars – widely believed to be a pathway to more affordable treatments for serious illnesses – will be delayed, perhaps for two or three years.
PDUFA, since its creation in 1992, has provided greater consistency, certainty and predictability in the FDA’s human drug review programs. Upon enactment, review times dropped by as much as three-fold in the first five years and have not increased. The creation of PDUFA has ensured American patients are among the first in the world to have access to new drugs.
Please let your Senators know that timely passage of the FDARA is a priority for patients. Thank you.
Senator Pat Roberts
Senator Jerry Moran
Senator Claire McCaskill
Senator Roy Blunt