FDA officials are thinking about ways to speed up the generic drug user fee negotiations amid worries talks will not finish by their late June deadline.

Delays could cause problems in getting the new program finalized and cleared by the Department of Health and Human Services and White House so Congress can approve it and other user fee programs on time. Congressional preference at this point continues to be including all of the user fee program in the same legislation.

Peter Beckerman, FDA's lead negotiator for the generic user fee program, said negotiations likely are going to have to be extended, but did not know how much more time the two sides would need. Still, the deadline to get the recommendations to Congress has not changed. It remains January 2012, he said.

Beckerman, senior policy advisor in the Office of Policy, said FDA and industry need to decide if dividing the two negotiating sides into small groups is an option to tackle more issues faster.

The Prescription Drug User Fee Act reauthorization talks included small groups meeting to discuss specific issues, including financial considerations and Risk Evaluation and Mitigation Strategies. Once agreements were reached, they were taken to the larger steering group for discussion and approval.

"We don't know what we're going to do about timing," Beckerman said following a May 10 public meeting to update interested parties on the generics talks. "We're not going to rush [the talks]."

Negotiations began in earnest Feb. 28, with both sides meeting about every two weeks in an effort to reach a deal on recommendations for a user fee program by the end of June. Before talks began, Beckerman admitted he was a little nervous about the tight schedule because both sides had a lot to accomplish in a short time (Also see "Generic User Fees Have Four-Month Negotiating Window As Differences Narrow" - Pink Sheet, 23 February, 2011.).

Program Simplicity Trumps Separation Of Backlog

Negotiations have not reached the stage of discussing specific fees, but now involve the activities that should be funded with user fees, he said.

Those ideals, which FDA and industry have called "four walls and a roof," included aiming for a 10-month review period for applications and conducting biennial inspections with parity between foreign and domestic facilities by the end of the first five-year cycle. Both sides also agreed the starting point for an annual user fee revenue level should be $250 million to $300 million (Also see "Generic User Fees Would Create 10-Month ANDA Review Time" - Pink Sheet, 2 May, 2011.).

A first-in, first-reviewed policy for most ANDAs and no separation of the current backlog of pending applications from new ones also were among the articulated principles. First-time generics and some other kinds of applications could be exceptions to that rule, the agency said.

Both sides agreed to a goal to reduce the backlog to a "steady state" by the end of the program's first cycle so new and pending applications could receive FDA action within FDA goal times.

Dealing with the application backlog is a primary issue to be resolved by the user fee program. The queue has reached about 2,000 applications and the average approval time is about 26 months.

Fellow FDA negotiator Russell Wesdyk, scientific coordinator for the Office of Pharmaceutical Science, which includes the Office of Generic Drugs, said the ultimate goal is not to completely eliminate the backlog because that would mean some FDA reviewers would be waiting for work to arrive at the agency.

Beckerman said the reason the user fee principles lump new and pending ANDAs together is to keep the program simple. He said creating a number of performance goals would make program administration more difficult.

"We're trying to think of one funnel," Beckerman said. "We currently got an awful lot of water in that funnel -- more water coming in, more applications coming in -- and we need to do our best to move everything through that pipeline."

Communication Issues Arise In Generic Arena, As In Brand Space

Among the comments during the meeting was a plea for more communication between sponsors and the agency during the review process. Applicants in some cases can wait six months to get an agency response on an issue and allowing conversations between reviewers, their supervisors and the sponsor would be an inexpensive way to increase agency efficiency, one speaker said.

Innovator companies identified similar issues in their application review system and negotiated mid- and late-cycle meetings between the agency and sponsors into the new molecular entity NDA and novel BLA review model as part of the PDUFA reauthorization (Also see "PDUFA V: Final Recommendations Fund Proposals In Two Of Three Tiers" - Pink Sheet, 2 May, 2011.).

Beckerman said the two sides have not talked about goals related to sponsor-agency meetings for GDUFA. But he acknowledged the concern about access and communication was not new.

-Derrick Gingery (d.gingery@elsevier.com)

Generic User Fee Negotiators Struggling To Meet June Deadline

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