BISA Speaks at Session, Meets with FAS to Improve FDA Advisory Committees
Washington, D.C., June 2024 — Maria Gmitro, president of BISA Nonprofit, and Sarah Beckom, BISA’s vice president, worked to improve the FDA’s Advisory Committee process at recent meetings in Washington, D.C.
The purpose of the meeting, known as a listening session, was to solicit feedback on the use of and processes for its advisory committee system, according to the FDA press release in April.
Here’s how BISA worked to contribute to the public meeting:
→ June 13, 2024: Gmitro represented BISA and spoke at the afternoon session of the FDA Public Meeting: “Optimizing FDA’s Use of and Processes for Advisory Committees.”
→ June 14, 2024: Gmitro and Beckom attended the post-meeting session with The Federation of American Scientists (FAS) in Washington, D.C.
To facilitate input, the FDA developed a series of topics covering the types of information it’s interested in obtaining:
Topic 1: Composition of Advisory Committees
Topic 2: Service on an Advisory Committee as a Special Government Employee (SGE)
Topic 3: Public Perception and Understanding of Advisory Committees
What is an FDA Advisory Committee?
FDA Advisory committees are comprised of external advisers and experts who support the FDA’s mission of protecting and promoting public health. The members provide independent advice and recommendations on scientific, technical, and policy matters; however, the FDA makes the final decisions on any matters considered by an advisory committee. Committees are either mandated by statute or established at the FDA’s discretion.
Why did BISA provide feedback on the topic of Advisory Committees?
BISA's mission is to protect and promote public health, so we felt it was important to discuss BISA’s experience with advisory committees, highlight concerns, and recommend improvements. Members of BISA contributed to the public statement, and Maria Gmitro spoke on Topic 3: Public Perception and Understanding of Advisory.
What is the FAS, and what was the purpose of meeting with them?
The Federation of American Scientists (FAS) conducted a post-meeting session on June 14, 2024, to dissect pivotal aspects of the FDA listening session and foster broad-based participation by crafting responses for submission to the official FDA docket regarding Advisory Committee policy reform.
Cheri Banks, a Health Regulatory Specialist at the Federation of American Scientists (FAS), led the follow-up meeting. FAS has been engaging FDA Advisory Committee (AC) members in dialogue about their experience in service and potential reforms to the FDA AC ecosystem. FAS aims to forge a roadmap for the FDA (that could also apply to other federal agencies) to more effectively involve experts in tackling public health issues.
What are next steps?
The FAS plans to develop a public comment that will be submitted to the FDA's official docket by August 13, 2024. BISA will meet with the FAS again in July to develop public comments with other organizations and advocates. We will share it on our website when it is completed.
How can I provide feedback to the FDA?
August 13, 2024 is the deadline to submit written/electronic comments to Docket No. FDA-2024-N-1809.
Additional information on commenting is available in the Federal Register notice.
Resources & References
Advisory Committees Give FDA Critical Advice and the Public a Voice | FDA
Learn About FDA Advisory Committees | FDA
FDA Public Meeting: Optimizing FDA’s Use of and Processes for Advisory Committees
FDA: How to Make Your Voice Heard - Comment on Proposed Regulations and Submit Petitions
FDA: About Advisory Committees
Conflict of Interest Among Public Speakers at FDA Advisory Committees
About Breast Implant Safety Alliance (BISA)
The Breast Implant Safety Alliance (BISA) is the largest organization of board-certified patient advocates and subject matter experts in the world dedicated to patient and consumer safety relating to breast implants. Representing the millions of individuals worldwide that currently have, had, or are considering breast implants, the alliance is a non-industry funded leading authority dedicated to providing balanced, evidence-based information for informed decision making about breast implant surgery and related issues. Founded in 2019 by women, BISA is a grassroots nonprofit organization led by volunteers who do not receive a salary for their work.
Contact: Maria Gmitro, President | maria@bisanonprofit.org