Sunset Rule Withdrawn; CBER’s Dr. Peter Marks Pens OP-ED on What Regulators Must Learn from COVID-19
Top-Line:
Legislative Update
New Acting Ranking Member on House Ag/FDA Appropriations Subcommittee
Sunset Rule Withdrawn
CDER’s Dr. Peter Marks Pens OP-ED on What Regulators Must Learn from COVID-19
FDA To Play Role in Administration Initiative Against PFAS Contamination
FDA Accelerating Advanced Manufacturing Initiatives.
Upcoming Alliance Webinars – On November 15 (Oncology Center of Excellence), December 6 (FDA gene therapy programs), and December 14 (FDA nutrition programs). Details below
Analysis and Commentary - Appropriations, Reconciliation, and ARPA-H
Legislative Update. Annual appropriations, reconciliation, and ARPA-H are all alive in the current Congress and each will affect FDA. This week’s Analysis and Commentary looks at each and provides an update on what has occurred and what happens next.
New Acting Ranking Member on House Ag/FDA Appropriations Subcommittee. Congressman Andy Harris (R-MD) was named this week as the Acting Ranking Minority Member on the House Ag/FDA Subcommittee. We previously reported that Congressman Jeff Fortenberry (R-NE) has temporarily stepped aside from that position in accordance with House Republican Conference Rules.
Sunset Rule Withdrawn. The Department of Health and Human Services has proposed withdrawal of a controversial Trump-era sunset rule. You can read more about it here.
CBER’s Dr. Peter Marks Pens Op-Ed on What Regulators Must Learn from COVID-19. You can read Dr. Marks comments here.
FDA To Play Role in Administration Initiative Against PFAS Contamination. President Biden announced accelerated efforts to protect Americans from per- and polyfluoroalkyl substances (PFAS), which can cause severe health problems and persist in the environment once released. The multi-agency initiative is being led by EPA. The FDA will continue to expand its testing of the food supply to measure dietary exposure to PFAS from food. It is also providing technical assistance to state and local governments and expanding its outreach to industry regarding food packaging (announcement here).
FDA Accelerating Manufacturing Initiatives. For more than 10 years, FDA has been encouraging the adoption of continuous manufacturing and other advanced approaches to production. The agency has benefitted from Congressional funding of these efforts, notably for projects in the FDA’s Emerging Technologies Program (ETP). FDA Voice, the agency’s blog, recently contained an overview of FDA and advanced manufacturing (article here and more here). As evidence of continuing Congressional interest, the House of Representatives passed HR 5369 on October 19, 2021. The bill is entitled: “National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021” and would authorize up to $100 million over 4 years to use a Centers of Excellence model to advance the field. (more here and here).
Upcoming Alliance Webinars. The Alliance is pleased to host FDA leadership to address the Alliance members and media in these upcoming webinars.
Oncology Center of Excellence Deputy Director Paul Kluetz is scheduled for November 15, 3:30-4:30 PM ET. The FDA Oncology Center of Excellence leverages the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, devices, and diagnostics. The Center helps expedite the development of medical products for oncologic and hematologic malignancies and supports an integrated approach to their clinical evaluation. Alliance members and media can register here
Director of the Office of Tissues and Advanced Therapies at CBER Wilson Bryan, MD is scheduled for December 6 at 10 a.m. His office is the front-line in the development of gene therapies. Sign up here.
Director of the Center for Food Safety and Advanced Nutrition, Susan Mayne is scheduled for December 14 at 2 p.m. She will be discussing FDA’s nutrition programs and major initiatives in that area. Sign up here.
Non-members interested in participating in any of these events should contact Alliance Executive Director Steven Grossman at: sgrossman@strengthenfda.org.
Why You Should Sign Up to Hear Dr. Kluetz. Our next webinar, on November 15, is with Dr. Paul Kluetz, Deputy Director of the FDA’s Oncology Center of Excellence (OCE). The Center was created in January 2017, with the goal of bringing together oncology scientists and reviewers from all the products centers. Subsequently, several Centers of Excellence have been created, notably in digital health. Dr. Kluetz will be discussing some of OCE’s accomplishments, as well as the strengths and weaknesses of this COE model for other disease areas.