Biosimilar User Fee Negotiations Hit Snag With GPhA Gambit For Lower Fees
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The Generic Pharmaceutical Association is balking at continuing to negotiate the design of a biosimilar user fee program that is independent of other user fees and has its own baseline appropriations trigger. While GPhA is against the ideas, two other industry trade groups negotiating the user fee program – the Biotechnology Industry Organization and Pharmaceutical Research and Manufacturers of America – support creating a separate review funding process. FDA’s proposals assumed the biosimilar user fee would be a separate program. Negotiations still are expected to produce a deal, even though talks seem to have run beyond their end-of-July target for completion. The disagreement stems from a proposal by GPhA and a representative of potential biosimilar sponsor Momenta Pharmaceuticals that biosimilar reviews remain part of the Prescription Drug User Fee program through fiscal year 2017, the end of the first biosimilar program cycle, according to minutes of a July 18 meeting. PDUFA fees are paid to support prescription drug and innovator biologic reviews. For the time being, biosimilar sponsors would also pay those fees to submit applications, although FDA does not appear to have received any so far. BIO and PhRMA said Congress, when it passed the biosimilar program in the Biologics Price Competition and Innovation Act, only intended PDUFA to support biosimilar reviews until the end of FY 2012. Both groups argued the use of PDUFA fees was intended to be transitional and temporary until a separate user fee program would be authorized. They opposed any PDUFA fees supporting biosimilar reviews beyond the transition period, according to the minutes, released Aug. 17. PhRMA also said Congress required separate biosimilar user fee negotiations because it intended the program to be independent. GPhA said Congress intended the program to be contained within PDUFA, according to the minutes. GPhA declined to comment further on its stance. Nic Scalfarotto, Momenta VP of regulatory affairs, who represented the company at the meeting, could not be reached for comment. The tactic could be a way to lower the cost of a biosimilar application. If the agency is forced to include biosimilars in the PDUFA program, it likely would have a more difficult time arguing it needed a strong funding base to ensure the program functions properly. GPhA said in written comments biosimilar fees should be 50% to 65% of the full BLA fee, in part because biosimilar data packages are expected to be less extensive (Also see "Biosimilar Product Development Fee Should Be Temporary, Trade Groups Say" - Pink Sheet, 20 Jun, 2011.). When industry representatives said during a June 30 negotiation they were concerned about biosimilars paying the same amount as BLAs, the agency said the program requires that level of funding to ensure business certainty and enable shorter review times. Budget Authority Trigger Also Disputed The fundamental disagreement also extended to discussions of budgetary triggers. PhRMA and BIO said a minimum appropriations amount devoted to biosimilars should be mandated in order for FDA to collect user fees. No potential trigger amounts were mentioned in the minutes. Any trigger likely will be much higher than the FY 2011 biosimilars budget: $1.8 million. GPhA said it did not think “such a condition was aligned with what they believed to be the congressional intent – to keep biosimilar review within the PDUFA program,” according to the minutes. The concept already is part of the PDUFA program. It ensures user fees continue to supplement, and not supplant, appropriations. PDUFA IV, which expires Oct. 1, 2012, also includes a reverse trigger that allows user fee revenue to decrease if appropriations exceed a pre-set level. PhRMA requested resource projections for all the user fee program components that had been disputed. FDA agreed to create the estimates, assuming the program was separate. A Reversal By GPhA? The minutes did not indicate the disagreement was resolved. GPhA said it would hold follow-up discussions with its executive committee about the independent biosimilar user fee program concept. Generic and brand trade groups are both part of the discussions because FDA decided to conduct the negotiations differently from other user fee discussions. Usually, major trade groups representing the regulated industry negotiated with FDA. For biosimilars, the agency allowed any industry players with a stake in the biosimilars market to sit at the negotiating table. The tactic was intended to promote inclusion for a market that still is in its infancy in the U.S. (Also see "Biosimilars: FDA Trying Group-Think Negotiating Strategy For User Fee" - Pink Sheet, 16 May, 2011.). GPhA said during the July 18 meeting it could not continue “detailed negotiations regarding volumes and metrics without agreement to parity with the PDUFA user fee program.” The position would seem to reverse one taken during a July 11 negotiation. Minutes indicated “industry stakeholders” and FDA agreed to support a flat product development fee of about 10% of the marketing application fee for the fiscal year while a biosimilar product was in the IND stage. The minutes did not indicate whether any industry negotiators dissented. FDA warned during the July 18 meeting that including biosimilar reviews in PDUFA would afford them less attention than an independent program. Less Biosimilar Certainty Under PDUFA? Agency officials said meetings and early development-stage activities like the product development fee would not be possible if biosimilar products were covered under PDUFA, according to the minutes. FDA proposed the product development fee to require sponsors pay a portion of the marketing application fee at IND filing. It is intended to support scientific activities and increased agency-sponsor interaction early in the development process (Also see "Biosimilar User Fees Would Be Same As BLAs, Only Earlier" - Pink Sheet, 9 May, 2011.). FDA said meeting parity with PDUFA could result in less certainty for sponsors during the development process because meetings would not be as detailed. Instead of allowing extensive data review and advice, the agency would offer Type B and C meetings, “where sponsors provide their summaries for high-level FDA review, not data for detailed review.” FDA advice would be “similarly high-level and caveated,” according to the minutes. Agreement Possible Without GPhA? It is unclear whether FDA could send a commitment letter to Capitol Hill for approval without support from a major trade group involved in the negotiations. Past successful user fee negotiations usually have ended with a commitment letter the agency and industry backed. The approach is partly intended to ensure Congress does not make changes to the goals outlined and endanger the agreement. If FDA went ahead with a commitment letter for a separate biosimilar user fee program and GPhA wanted to press the issue, the generic group would presumably need to convince legislators that its interpretation of the 2007 bill creating the new approval pathway was correct. Members of Congress already have their own agendas for the biosimilar and other user fee bills and some have signaled problems will develop if FDA does not improve regulatory performance (Also see "Burr Warns User Fee Renewal Could Be Difficult Without Performance Measure Improvements" - Pink Sheet, 28 Jul, 2011.). Congressional dissention could slow passage of all the user fee bills up for approval: a new fee for generic drugs as well as the PDUFA and medical device user fee reauthorizations, in addition to the biosimilar program. The legislative package is also expected to address supply chain globalization issues to some degree. |