A more collaborative style in the narrowly divided Senate should make it easier for industry to gain a hearing on PDUFA and
other important issues. Senate Health, Education, Labor and Pensions (HELP) Committee chairman Sen. Ted Kennedy (D-MA) has
co-sponsored drug-safety legislation with now-ranking minority member Mike Enzi (R-WY), and the two plan to work together
on PDUFA reauthorization. But the departure of several conservative Republicans from the HELP committee, and the addition
of sharp industry critics, such as the new Democratic Senator from Ohio, Sherrod Brown, may heighten the rhetoric on high
drug prices and deceptive industry practices.
Trimming the Tree
With Democrats and Republicans unlikely to agree on many legislative proposals, both sides will regard any PDUFA bill as a
vehicle for a broad range of pet healthcare issues. Measures to enhance drug safety, speed generics to market, and expand
drug importing are all likely to be hung on the PDUFA Christmas tree. There may even be a move to give FDA authority to regulate
"All these issues will be in play," acknowledges Greenwood. Industry's task is to identify a working majority in the House
and Senate that can "deal with these issues responsibly," he says; with PDUFA, "we can't play veto games."
FDA and industry leaders have been discussing user-fee issues for several months. As in the last three reauthorizations, the
agency aims to present a plan to Congress early next year. This will include proposed fees, timelines for application processing,
and the range of FDA activities that fees will support.
One issue is whether generic-drug makers will agree to pay user fees, and whether there will be major changes in fees for
medical-device makers. Congressional leaders will be looking for ways to provide more resources for FDA activities not directly
related to application review, which is expected to set off a sharp debate on just what user fees should pay for.
When PDUFA was renewed five years ago, the administration and GOP Congressional leaders worked with industry to avoid a big
Christmas tree bill. But "that was then; this is now," comments attorney John Manthei, a former Congressional staffer. It's
a whole new ball game in Washington.
Jill Wechsler is Pharm Exec's Washington correspondent. She can be reached at email@example.com