[author: Jake Handy]
The Prescription Drug User Fee Act (PDUFA) re-authorization wrangling is underway on Capitol Hill. Today the House of Representatives takes up its version of the FDA bill the Senate passed last week. On May 24th the Senate version of the PDUFA bill passed on a 96-1 vote. The current PDUFA will expire on October 1st and debates in the House could, potentially, take all summer. However, legislators and industry observers have expressed hope for a final bill to be presented to the President for signature in early July. We'll be closely following the progress of the reconciliation of the House and Senate bills.
Estimates vary but the present PDUFA will likely bring in around 6.4 billion dollars to FDA over its active period. Since PDUFA fees account for the majority of the FDA's drug review budget, the core PDUFA legislative mandate has broad bi-partisan support. While PDUFA itself is fairly non-controversial, the various amendments that were attached at the beginning of the week led to intense debate. Many of those proposed amendments - such as energy drink registration and Canadian drug importation - were dropped from the final version of the Senate bill.
Both the existing House version being debated today and the Senate version passed last week contain, in addition to the core PDUFA, provisions related to the drug approval process. Specifically, both bills attempt to speed up the approval process by creating special designations for drugs that can be permitted to meet easier clinical end points, or meet actionable data end points earlier in the process. Both bills provide for a "breakthrough" drugs designation, which would live alongside FDA's existing "fast track" designation. Of course FDA will be tasked with creating written guidelines over the next 18 months which will hopefully clarify these muddy waters. Nevertheless, the overall message being sent from both houses of Congress is clear: new or life-saving drugs need to be designated in such a way that they can get through the approval process faster than they might have in the past.
A few additional notes from the Senate bill:
- FDA will have increased competency and jurisdiction to inspect foreign plants that manufacture ingredients for US-market drugs. Certain US facility inspection timetables would be scrapped in favor of agency freedom to address overseas plants (note that the vast majority of ingredients in US pharmaceuticals are made in foreign facilities). Foreign companies that do not cooperate with FDA inspection may find their goods seized at the border by Customs.
- MDUFA, the medical device version of PDUFA, was also reauthorized with a provision permitting FDA to dramatically increase these fees. However, because these fees were comparatively modest to begin with, and in general medical device user fees cover a much smaller percentage of FDA's device-review budget, there was broad support for the measure - especially given FDA assurances that increased fees would speed up the medical device approval process, which was the subject of much recent industry and Congressional criticism.
- New user fee program for generics and biosimilars, with many of the details for the latter yet to be worked out (in tandem with the development of a biosimilar approval pathway).