05/14/2024
On April 29th, 2024 the US Food and Drug administration (FDA) posted a news release outlining an upcoming virtual listening session June 13th, 2024 from 9:00am–4:00pm ET, on the optimal use of and processes for FDA advisory committees (Ad Com). FDA Ad Coms are intended to provide the agency with advice and recommendations from the public as well as external experts from various backgrounds. They review the safety, effectiveness, and appropriate use of products in FDA regulated research by discussing scientific, technical, and policy issues and voting on proposed future actions. The FDA has numerous Ad Coms each tasked with reviewing their own unique topics in research. Research topics include but are not limited to; Digital Health, Medical Devices, Human Drugs, Patient Engagement, as well as Blood, Vaccines, and Other Biologics (for a full list of FDA Ad Coms and further information on each, click here). Each committee typically consists of nine personnel (they may have more, for example the Pediatric Ad Com has fourteen voting members) that fall into one of four membership types:
Academician/Practitioner: These are science-oriented qualified professionals/experts in their field such as engineers, chemists, biologists, physician-researchers, medical faculty, and statisticians that use their knowledge to serve on an Ad Com as either a;
Scientific/Technical Member,
Ex-Officio Member,
Patient Family Representative,
Pediatric Health Organization Representative,
Health Professional Representative,
Government Representative (non-FDA),
Or General Public Representative.
Consumer Representative: These are members who serve to represent consumers, associations, coalitions, and consumer organizations interested in the products the FDA intends to develop. Consumer Representatives must be active member or have an ongoing affiliation with a consumer or community-based organization. They are required to able to understand the scientific data, research design, and risks and benefits involved in the research, as well as evaluate the safety and efficacy of the research.
Industry Representative: Acting on behalf of regulated industry they provide the perspective of the industry affected by the research as opposed to an individual from a specific sponsor or firm. They are considered nonvoting-members.
FDA Patient Representatives: This role on the Ad Com is for both patients and caregivers that have either experienced the disease, condition, or device that is the focus of the research (autism, HIV, ovarian cancer, etc.) or is the primary caregiver of the patient. These members are able to give accurate insight on patient’s needs, priorities, and preferences.
Meetings are conducted at any stage of medical product development including post-marketing. The meetings are posted on the Federal Register at least 15 days in advanced along with times, locations, topics, web-links, and instruction on how the public can comment on the open docket. This input from the public is key to working towards an open and transparent government as all the comments to the open dockets are addressed so that the public can have an understanding on what is taking place and what they can expect in future developments. The FDA is exploring innovations that could optimize Ad Com policies and practices, these innovations include:
Modernizing systems to reduce paperwork and streamline processes
Improving utility of the advice received from Ad Coms
Amplifying recruitment of potential Ad Com members
Establishing mechanisms to share and standardize certain practices and procedures
Working to improve public understanding of Ad Coms
The FDA’s goals for this upcoming listening session will be to collect feedback about how to optimize the processes and policies of Ad Coms. This includes feedback on how the agency reduce administrative barriers for individuals interested in serving on Ad Coms and how to improve the publics understanding of what FDA Ad Coms role is and clarify any misconceptions. A common public misconception is that the Ad Com’s votes dictate what the FDA will do in the future, when in reality the vote is a recommendation that is considered amongst other factors. With the innovations and goals in mind the topics/questions that are to be covered at the upcoming listening session include but are not limited to:
Composition of Ad Coms
What are the categories of expertise, viewpoints, or voices that are particularly important for representation in Ad Coms? Which categories may not be relevant given the focal topic or product type?
Are there ways the FDA can better incorporate the consumer or patient voice into Ad Com meetings?
Service on an Ad Com as a Special Government Employee (SGE)
How can the FDA mitigate administrative barriers to service for SGEs?
How can the FDA otherwise improve the experience of Ad Com members?
Public perception and understanding or Ad Coms
What do you perceive to be the public’s awareness and understanding of the role of FDA Ad Coms?
What steps can the FDA take to improve public awareness and understanding of Ad Coms?
The listening session will take place on Zoom, those interested in attending can register here any time before the listening session begins on June 13th 9:00am ET. If you would like to request to speak during the session, use the same link to register and fill out the form accordingly before 3:00pm on May 13th. The FDA will select from the requested oral presentations and notify those chosen by June 3rd. Those chosen will be expected to submit all presentation materials in PDF format to ACFeedback@fda.hhs.gov as well at to the open docket by June 7th. For those who wish to comment (written or electronic) on the docket may do so here until August 13th (for more information see the Federal Register Notice). For a full list of topics and questions being covered in the listening session, click here. For more information on FDA Ad Coms including FAQs about Ad Com meetings please see the following links:
FAQ on FDA Advisory Committee Meetings
Advisory Committees Give FDA Critical Advice and the Public a Voice
Learn About FDA advisory Committees
- The Clinical Pathways Team
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