More Competition: Senator Proposes Priority Reviews for Some Generics, New Voucher Program

Posted 03 March 2016 By Zachary Brennan


In looking for ways to create more competition in the US pharmaceutical industry and drive down rising prices, a new Senate bill proposes to prioritize certain generic drug applications and to create a priority review voucher program to incentivize the development of new generics.

Sen. Susan Collins’ (R-ME) bill, known as “A bill to increase competition in the pharmaceutical industry,” would amend the Federal Food, Drug, and Cosmetic Act to require the US Food and Drug Administration (FDA) to decide on abbreviated new drug applications (ANDAs) no later than 150 calendar days after the date of the submission if the generic “has been introduced into interstate commerce by not more than one manufacturer or sponsor, as applicable, in the last 3 months” or if it’s on FDA’s drug shortage list.

Chip Davis, President and CEO of the Generic Pharmaceutical Association, expressed support for the bill, saying in a statement: “GPhA appreciates that Senate Aging Committee Chair Susan Collins and Ranking Member Claire McCaskill recognize the need to address the rising costs of brand and specialty medicines by increasing pharmaceutical competition...The Competition in Pharmaceuticals Act takes important steps toward encouraging competition and enhancing patient access. We look forward to working with Sens. Collins, McCaskill and others to ensure that generic drugs can continue to expand access and drive savings for millions of Americans.”

The new bill comes as CDER Director Janet Woodcock said in January that the ANDA backlog of nearly 3,000 ANDAs will be eliminated before the second iteration of the Generic Drug User Fee Act. She also said this year, FDA will take about 15 months to respond to a generic firm on its ANDA, though in October 2016, companies can expect to get a response within 10 months.

Currently there are 99 generics with only one generic competitor, 66 with two competitors, and all the rest have multiple competitors, according to FDA statistics.

Generic Priority Voucher Program

And just a day after FDA said the priority review voucher program for rare pediatric diseases should not be reauthorized by Congress in October, this new bill would create a similar voucher program for generics that would expire in 2022.

But unlike with the other two voucher systems, this would require FDA to act on an ANDA in 150 calendar days, or five months (rather than the six months priority review for new drugs) and the vouchers can only be used to speed the review of other ANDAs, and only if there’s one competing generic on the market or if the generic is on FDA’s drug shortage list.

And similarly to the other two voucher programs, this new generic one would allow for vouchers to be exchanged between companies, and the voucher can be revoked if the drug for which such voucher was awarded is not marketed in the US within the 365-day period beginning on the date of the drug’s approval.

“The sudden, aggressive price hikes for a variety of recently acquired off-patent drugs that have been used widely for decades, for which there is no generic drug competitor, also affects access to affordable prescriptions for patients and the overall cost of health care in the United States,” the bill says.


In addition to the new voucher program, Collins’ bill would direct the Government Accountability Office to review the implementation and effectiveness of the risk evaluation and mitigation strategy (REMS), its burdens, the standards applied by FDA and additional strategies imposed by companies outside of their REMS programs.

S.2615 – Increasing Competition in Pharmaceuticals Act


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Categories: Generic drugs, Government affairs, Research and development, Submission and registration, News, US, FDA

Tags: generic drugs, priority review voucher, Janet Woodcock, Susan Collins

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