FDA User Fee Negotiations Concluded; CLSA to Participate in Reauthorization Process

Sept. 12, 2016

During the August Recess, the U.S. Food and Drug Administration (FDA) and industry concluded preliminary negotiations to define the terms under which the agency will be authorized to collect industry-paid user fees to support their review activities on medical devices and prescription drugs and biologics (learn more about the draft MDUFA agreement or the draft PDUFA agreement).

Funds collected under the Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Act (MDUFA) – both most recently reauthorized by the FDA Safety & Modernization Act (FDASIA) in 2012 – support approximately three-quarters of the agency’s review activities for prescriptions drugs, and approximately one-third of the agency’s review activities for medical devices. Under the preliminary agreements recently negotiated between FDA and industry this summer, user fees will further increase the agency’s funding for review activities for both programs. The agency will also be expected to meet heightened performance goals to ensure timely review of medical product applications and speed patient access to new technologies and treatments. The FDA’s current authority to collect user fees expires Sept. 30, 2017. Because of the importance of user fees to FDA’s budget, PDUFA and MDUFA are considered “must pass” legislation, and Congress is expected to include additional legislation, known as “riders,” to the reauthorization bill to address a range of other related concerns and interests.

While CLSA does not actively participate in negotiating the industry-agency user fee agreement, we are in a unique position to be a resource on and advocate for FDA-related issues. Our current California congressional delegation currently holds five seats on the House Energy & Commerce Committee (the committee with jurisdiction over FDA and the user fee programs), and depending on the outcome of the election, our state is likely to gain at least one additional seat in the new Congress.

Also worth noting, 19 of our delegation’s members are in their first or second term of federal office, meaning neither they nor their staff have ever participated in a user fee reauthorization process. To this end, CLSA is in the process or organizing a series of meetings and briefings to ensure that all California delegation members and staff are aware of the importance of FDA user fees in supporting the agency’s mission to bring innovative products to patients quickly and safely. In particular, and in collaboration with bipartisan members of our delegation, CLSA will convene a series of staff-level “101” informational briefings to prepare delegation staff for the range of topics that will be addressed during the congressional portion of the user fee reauthorization process in 2017. We will also continue our partnership with Boston Consulting Group (BCG) to publish updated FDA drug and device review and performance data as part of our work to monitor FDASIA implementation and suggest further refinements and improvements to the regulatory process, both through the user fee renewal process and FDA’s administrative changes.

Questions? Please contact Jenny Carey, CLSA’s Vice President of Federal Government Relations & Alliance Development (