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Press Release

#SubHealth Focuses on Reauthorizing and Improving Important User Fee Programs


Members Discussed Enhancements Implemented in GDUFA and BsUFA Reauthorizations – Two Programs Critical to Bringing Life-Saving Drugs to Market

WASHINGTON, DC – The Subcommittee on Health, chaired by Rep. Michael C. Burgess, M.D. (R-TX), today held a hearing examining the Generic Drug User Fee Amendments of 2012 (GDUFA) and the Biosimilar User Fee Act of 2012 (BsUFA), both of which expire in September of 2017 and must be reauthorized for the Fiscal Years 2018-2022. Also discussed during today’s hearing was legislation introduced by Representatives Gus Bilirakis (R-FL) and Kurt Schrader (D-OR) – H.R. 749, the Lower Costs Through Competition Act.  Today’s hearing was important to understand the drug review process and how we can safely, and expeditiously, move life-saving drugs to the market.

Chairman Burgess began today’s hearing with encouraging words regarding the timing of the reauthorizations, stating, “I would also like to commend the FDA and industry for the various briefings they provided our members’ staffs throughout the negotiation process, and for transmitting the proposed agreements to Congress in a timely manner pursuant to the process laid out in statute.” 

Dr. Woodcock listens to questions from Chairman Burgess

On the first panel, witness Janet Woodcock, M.D., Director, Center for Drug Evaluation of Research at the Food and Drug Administration (FDA), recapped the numerous benefits that GDUFA I has provided and why passing GDUFA II is so critical. “GDUFA has expanded access to affordable generic medicines. About 25 percent of all generic drugs that FDA has ever approved were approved in the past four years. At the same time, GDUFA helps assure the quality of generic drugs.”

The second panel allowed for members to again hear from industry representatives about the steps taken to improve review processes in places and why Congress should prioritize the reauthorization of both GDUFA and BsUFA. Offering perspective on the significance of reauthorizing BsUFA and the best way to keep generic drug pricing down in cost, was witness David R. Gaugh, R.PH, the Senior Vice President for Sciences and Regulatory Affairs at the Association for Accessible Medicines (AAM). Speaking to the improvements made in GDUFA II, Mr. Gaugh relayed, “The priority of the generic drug industry in the GDUFA II negotiations was to achieve a more effective and transparent generic drug review program.  We believe that accomplishing this goal will improve the rate of first-cycle approvals on the earliest legally eligible date through greater transparency and communication during the review process….Our industry’s goal was not merely a faster FDA review timeline, but a more effective review process… [w]e strongly believe GDUFA II is well positioned to achieve this goal.”

An underlying theme of today’s hearing included a discussion surrounding enhancements made to BsUFA II. Speaking to the improvements in the review process of biosimilar applications was Kay Holcombe, Senior Vice President of Science Policy at Biotechnology Innovation Organization. She testified, “A new approach to the review of biosimilars applications will be implemented during BsUFA II, which is modeled after the so-called “new NME” program under PDUFA. The anticipated advantage of this program is an increase in the number of first-cycle approvals –saving time and money for sponsors and, importantly, making approved products available to patients as efficiently as possible.”

Juliana Reed, the Immediate Past President at The Biosimiliars Forum, echoed Ms. Holcombe when speaking to the improvements made within BsUFA II. “There are significant  enhancements to the Biosimilar User Fee program that support  the review and approval of biosimilar medicines in the U.S” including, “[a] revised review process meant to increase transparency and communication,” “[a]gency commitments to complete and publish several draft and final guidance documents” and “[e]nhancements to the user fee structure.

Bruce A. Leicher, Board Chair of The Biosimilars Council, emphasized the importance of innovation in biosimilar development, and how BsUFA II is critical to ensuring continued innovation. He stated, “In addition, even more innovation is underway to allow for approval of interchangeable biologics which can be shown to perform the same in any given patient and, when approved, substituted at the pharmacy like generic drugs. This innovation is what makes biosimilars competitive, affordable, safe and effective for patients. But, these innovations squarely depend on having the critical additional FDA resources funded by BsUFA II.

For more information on todays hearing, including a background memo, witness testimony, and archived webcast, click HERE. ­


Health (115th Congress)
Press Release