The prospect of FDA obtaining a combined bill reauthorizing existing user fee programs and creating two others could be challenging, given that some negotiations have yet to begin and agreements may not be completed fast enough to meet congressional time tables.

Schedules do not appear to be lining up to have the Prescription Drug User Fee Act and Medical Device User Fee and Modernization Act reauthorizations, as well as the upcoming generic and biosimilar user fees, in a single bill.

Congressional leaders may be targeting this fall to begin holding hearings on the user fee bills, which would require agreements to be substantially completed. PDUFA is on pace to have a completed agreement in time, but MDUFMA is not, according to FDA’s lead negotiator for that agreement.

However, a Senate staffer said there still is confidence the user fees will be included in one package that could be passed before authorization for the existing programs expire on Sept. 30, 2012.

Even if problems arise in negotiations, it is too early to view those as problematic to reauthorization efforts, the staffer said. The staffer said there is still plenty of time, about 20 months, for the fee agreements to be completed and passed.

Further complicating the process are the negotiations on the generic drugs user fee act (GDUFA) and the biosimilar user fee act (BSUFA, perhaps?), which have not started yet.

The first GDUFA negotiations are scheduled for the end of the month, Peter Beckerman, senior policy advisor in the Office of the Commissioner, who is leading the FDA team, said Feb. 10 during the Health Leaders Dialogue 2011 conference in Washington, D.C.

The beginning of the formal negotiations seems to coincide with the closing of the docket, which FDA had reopened to get broader input from suppliers and other stakeholders (Also see "Generic User Fees: FDA Reaches Out To More Trade Groups; Plan Could Mix Inspection and Application Fees" - Pink Sheet, 3 January, 2011.).

Biosimilar User Fee Negociations Will Be Multi-Party Talks

For biosimilars, a Federal Register notice heralding the start of the user fee negotiation process is expected out in the next few months, said Theresa Mullin, director of the CDER Office of Planning and Informatics, who will be leading the FDA negotiators.

Mullin, who also is heading the PDUFA negotiations for FDA, said she is cognizant of the pending fall deadlines and is trying to wrap up PDUFA talks so the focus can move to biosimilars.

Early signs indicate those negotiations may depart dramatically from their user fee cousins. Mullin said determining which industry group will sit at the biosimilar negotiating table will take some thought. Brand and generic associations already have shown interest, she said.

“There is no industry per se nor is there a single association that represents their interests,” Mullin said. “We don’t think the traditional approach we’ve taken to user fee negotiations with PDUFA and MDUFMA is going to work here because it’s such a nascent industry. So we’re trying to come up with a process that gets to the concerns of all the stakeholders.”

The agency took the first step in the process late last year, when it published a Federal Register notice soliciting stakeholder interest (Also see "Caring Agency Seeks Stable Partner For FOB User Fee Negotiations" - Pink Sheet, 27 September, 2010.).

BIO wants to be part of the biosimilar user fee negotiations to ensure that resources are not drained away from the review of innovator products.

Mullin said innovator companies already indicated they do not want to subsidize biosimilar development by allowing BLA user fees to pay for review staff work on abbreviated applications. She said the agency also does not want to create disadvantages for biosimilar applicants.

The Biotechnology Industry Organization said in an e-mail that it "seeks to be part of that process in order to ensure that such user fees adequately reflect the time and resources that FDA will need to thoroughly review biosimilar applicants, so that resources are not drained away from agency review of innovator products."

Innovator and generic companies fell on opposite sides of several issues during a public hearing last year on implementation of the abbreviated biosimilar pathway (“FDA Searches For Clinical Trial Middle Ground At Biosimilar Hearing,” “The Pink Sheet,” Nov. 8, 2010).

FDA had a similar problem when gearing up for generic drug user fee negotiations. The Generic Pharmaceutical Association had been the trade association expected to lead the industry negotiating team, but a few large generic companies formed their own group, the Generic Drug User Fee Coalition, which pushed some different ideas for the user fee program (Also see "ANDA User Fee Negotiations: A Big-Firm Coalition Tackles The Big Backlog" - Pink Sheet, 13 September, 2010.).

FDA said it needed a united industry proposal before negotiations could begin. The two camps were never far apart, and the issue was ultimately resolved when most of the collation members rejoined GPhA (Also see "Hospira The Holdout" - Pink Sheet, 10 January, 2011.).

Such a unification solution will not present itself for biosimilars, though Teva is working to get two seats at the table (Also see "Teva Extends Diversification To Lobbying, Not Just Product Mix; Seeks To Join BIO" - Pink Sheet, 14 February, 2011.).

PDUFA Could Be Ready By Fall

There have been at least 11 PDUFA negotiating sessions between FDA and industry, as well as six meetings with stakeholder groups, and talks are projected to end this month. Mullin said a draft package of proposed recommendations is scheduled to be completed and reviewed by federal officials by August. A public meeting about the proposal would be held in September.

Final recommendations are due to Congress in January so the reauthorization bill can be passed before its October 2012 sunset.

This will be the first cycle that user fee authorization falls in a presidential election year (the program was created during one in 1992) and House members appear to want to get the bill passed by June 2012 to avoid legislative entanglements. To keep that schedule, they could push for committee hearings on the bill this fall. However, a Senate staffer said there have been no discussions about this with the other chamber.

Mullin said she thought the PDUFA reauthorization could be ready for hearings this fall because the proposed recommendation hopefully will closely resemble the final version of the agreement. She indicated ongoing stakeholder meetings should dramatically reduce the number of surprises and demands for drastic changes.

The MDUFMA process is not as far along, said lead FDA negotiator Malcolm Bertoni, assistant commissioner for planning and director of the Office of Planning in the Office of the Commissioner.

Bertoni said industry negotiations and stakeholder meetings are under way, but several months behind PDUFA. He said they are hoping to wrap up talks this summer.

That schedule would make having an agreement ready for public hearings in the fall difficult. Bertoni said if congressional hearings for PDUFA take a lot of time initially, MDUFMA could “get in line afterwards.”

“To think that we would have gone through the public participation process by the fall I don’t think is realistic,” he said.

If all the user fee agreements are not ready in time for the congressional schedule, FDA may have to explore other legislative vehicles for the user fees that don’t make the initial bill.

The User Fee Christmas Tree

The user fee bill is considered “must-pass” legislation because of its importance to FDA and industry. However, it also means the legislation could be filled with legislators’ ideas for reforming the agency.

Scott Gottlieb, resident fellow at the American Enterprise Institute and former FDA deputy commissioner for medical and scientific affairs, said at the conference there is a lot of chatter on Capitol Hill about ideas to attach to the PDUFA bill.

Gottlieb mentioned an innovation agenda, which President Obama has said should be a priority, could be included. However, there may not be time to produce another large reform bill like the FDA Modernization Act of 1997.

“Members of the House are actively looking for ideas and so they’d have to be fully baked ideas to get into ... the dialogue at this point,” Gottlieb said.

“The challenge is I think it’s a little late in the game,” Gottlieb said. “The members of the House are actively looking for ideas and so they’d have to be fully baked ideas to get into … the dialogue at this point.”

The last time authorization occurred in an election year it produced a relatively "clean" bill that was signed in late spring (Also see "PDUFA III Implementation Begins: FDA Working Groups Under Way" - Pink Sheet, 17 June, 2002.).

By Derrick Gingery

"Mega-UFA" Is Behind Schedule; Combined User Fee Bill Will Be Difficult, But Still Expected

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