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Alliance Comments on the FDA’s Commitment Letter for PDUFA VI

August 30, 2016   |   Alliance for Aging Research Team   |   FDA & Regulatory Policy, Patient-focused Drug Development
United States Capitol Building.

In response to a call from the U.S. Food and Drug Administration (FDA) for feedback on its proposed Commitment Letter for the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA), the Alliance for Aging Research submitted comments to the FDA for consideration. This post offers an overview of the Alliance’s comments. (Full comments are available here.)

First, here’s a brief summary of PDUFA. PDUFA allows the FDA to collect user fees from drug manufacturers to help fund the human drug review process. It was first passed in 1992, and it is reauthorized every five years. PDUFA is up for renewal in 2017. FDA’s Commitment Letter outlines the Agency’s and Industry’s proposed goals for PDUFA’s sixth reauthorization. If you are interested in learning more about PDUFA, this site offers a comprehensive summary.

The Alliance has been active in the PDUFA VI discussions by offering feedback to FDA senior representatives during monthly stakeholder meetings and by participating on panels during the public meeting held to kick off the reauthorization process in July of 2015 and at an August 2016 public meeting focused on the PDUFA VI Commitment Letter.

In the comments, the Alliance responded very positively to the Commitment Letter, noting: “We recognize the critical role that the Prescription Drug User Fee Act (PDUFA) plays in maintaining processes across the human drug review program that allow patients timely access to safe and innovative treatments, particularly in areas of unmet need like Alzheimer’s disease and sarcopenia. We believe that PDUFA VI offers a critical next step in giving the FDA the additional resources it requires to continue to deliver these treatments to patients so they can live healthier, happier lives. We look forward to working with Congress on enacting legislation to reauthorize this important program and hope to serve as a resource to the FDA as you implement the transformative initiatives supported by PDUFA VI.”

Below are highlights of the Alliance’s comments:

The Alliance provided comments on Part I, Section I: Enhancing regulatory science and expediting drug development. The Alliance specifically supported: the utilization of user fees to maintain dedicated staff within the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) focused on improved communication between the FDA and sponsors during drug development (Section I, number 1); early consultation on the use of new surrogate endpoints (Section I, number 3); advancing the development of combination products (Section I, number 5); and enhancing the use of real-world evidence in regulatory decision making (Section I, number 6).

The Alliance made several comments in Part I, Section J, of the letter that focused on “enhancing regulatory decision tools to support development and review.”

  • Section J, number 1b: This complements the internal changes at the FDA in the area of patient focused drug development (PFDD) by laying out a clear process for developing sequential guidance with full participation from the patient advocacy community, industry, and FDA on the collection of patient input leading to the development of patient-centered measures. The Alliance added: “We strongly support FDA’s leadership in PFDD…The proposed outlined process maintains and clarifies FDA’s role, while providing much-needed user fee funding for external capacity building.”
  • Section J, number 2: “The updated benefit risk implementation plan, planned public meeting, and proposed draft guidance outlined in this section will enable more productive activities in the stakeholder community to capture patient experiences and communicate those findings to the FDA throughout the drug development process and at the time of product review.”
  • Section J, numbers 3 and 4: “These sections greatly enhance FDA’s ability to advance the future of drug development through the addition of staff with expertise in statistical modeling and innovative clinical trial designs.”
  • Section J, number 6 a-f: “We support the dedication of funds under this section to expand base capacity within the qualification review team and to host a series of public meetings resulting in guidance that strengthen the DDT Qualification Process.”

The Alliance also offered comments on Part III: Improving FDA Hiring and Retention of Review Staff. It noted, “In our view this is one of the most critical components of the Commitment Letter because the agency will only be successful in carrying out all of the activities we care about in PDUFA VI if it has the best and the brightest people and continued stability in its’ workforce. To do this, FDA needs to compete on a level playing field with the private sector and other federal agencies.” It highlighted several areas:

  • Section A: “Two highlights of this section are 1) FDA’s commitment to reviewing and cataloguing existing position announcements in order to implement a comprehensive online position classification system, and 2) the FDA’s planned efforts to transition away from time-limited individual position vacancy announcements. We think that both of these are positive steps forward.”
  • Section B: “Because of chronic challenges in retaining and recruiting enough human resources professionals, FDA needs to supplement in-house staff with external expertise. As outlined in this section, this would allow the Agency to retain a qualified hiring contractor. Employing this contractor will assist FDA in successfully meeting goals for recruitment of human drug review program staff.”
  • Section C: The establishment of “a dedicated unit within the Office of Medical Products and Tobacco with a continuous focus on hiring and staffing issues” will allow FDA to “keep pace with scientific and technologic advances.”
  • Section D: “This section demonstrates the Agency’s commitment to accountability and a desire to measure progress in targeting hires within the human drug review staff. We applaud [FDA] for taking this step.”
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