Public Engagement Critical to Further Enhance
Input from External Expert Panels
SILVER
SPRING, Md., April 29,
2024 /PRNewswire/ -- Today, the U.S. Food and Drug
Administration announced it will host a listening session in
June as part of its broader work to optimize the use of, and
processes for, advisory committees. This virtual public meeting
will focus on the composition of advisory committees, ways to
improve the experience for members serving on committees and ways
to ensure public awareness and understanding of the role of FDA
advisory committees.
Advisory committees are typically made up of technical,
scientific, public health and medical experts, as well as
representatives of industry, consumer organizations and patients.
They provide the FDA with independent advice on many topics,
including the development, use and evaluation of drugs, biological
products, medical devices and tobacco products, as well as broader
scientific, medical and public health topics. Advisory committees
provide non-binding recommendations to the agency, and final
decisions are made by the FDA.
"The FDA regulates products that
impact the everyday lives of the American people,
and advisory committees play a key role in
that process. It's important we have the
right expertise, diverse viewpoints and other processes in place to
ensure the agency gets timely and sound advice," said FDA
Commissioner Robert M. Califf, M.D.
"We are hopeful this listening session will provide valuable
feedback on optimizing the advisory committees' role in the
agency's science-based decisions and its mission in protecting and
promoting public health."
For the listening session, the agency is seeking input on
whether there are ways the FDA can better incorporate a variety of
diverse perspectives and experiences, as well as consumer and
patient voices into advisory committee meetings. The FDA also wants
feedback on how it could streamline any administrative burdens
(e.g., the amount of onboarding paperwork and processing time) that
may make it less likely for an individual to want to serve on a
committee. Additionally, the agency is interested in hearing about
how it could improve the public's awareness and understanding of
the role of FDA advisory committees. For example, the FDA is
seeking input on if it could update any processes on advisory
committee discussion and/or voting that would clarify any
misconception that advisory committee votes are binding on the
agency's final decision rather than recommendations that are only
one of several factors considered in the FDA's decisions.
"Although all decisions are made by FDA staff, the
discussions that take place at advisory committee meetings are
important pieces that are considered as part of the FDA's
decision-making," said FDA Principal Deputy Commissioner
Namandjé Bumpus, Ph.D. "Gathering broad
feedback on the advisory committee process and how
these committees inform agency decisions in an open and
transparent platform will inform our work to further enhance how
the FDA uses the input of our external experts."
The FDA is currently considering how advisory committee policies
and practices can be optimized. These efforts include:
(1) initiatives to modernize systems to reduce paperwork
burden and streamline processes; (2) exploring ways to improve
the utility of advice received from advisory committees; (3)
considering ways to amplify recruitment of potential committee
members, possibly through increasing dedicated staff and engaging
existing committee members; (4) establishing mechanisms to
share and standardize certain practices and procedures across the
agency; and (5) working to improve public understanding of
advisory committees and the roles they play. Although some of these
potential initiatives are geared toward internal processes, the FDA
expects to engage the public and committee members through the
course of these efforts when appropriate, including through the
public listening session.
The agency will hold the virtual listening session on
June 13 from 9
a.m. to 4 p.m. ET. To register for the free public meeting,
please visit the FDA's website. Input from the public may be
provided orally or written; however, in all cases, the FDA
encourages participants to provide the specific rationale and basis
for their comments, including any available supporting data and
information. Those interested in making an oral presentation at
this public meeting must register by 3 p.m.
ET on May 13. The FDA is
establishing a public docket for this listening session. Electronic
comments must be submitted to the https://www.regulations.gov
electronic filing system on or before August
13, 2024. Registration to speak at the meeting is based on
space availability, with priority given to early registrants.
Information on requests for special accommodations due to a
disability will be provided during registration.
# # #
Media Contact: Courtney
Rhodes, 202-281-5237
Consumer Inquiries: 888-INFO-FDA
The FDA, an agency within the U.S. Department
of Health and Human Services, protects the public health by
assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the
safety and security of our nation's food supply, cosmetics, dietary
supplements, radiation-emitting electronic products, and for
regulating tobacco products.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/fda-to-hold-listening-session-as-part-of-broader-work-to-optimize-use-of-and-processes-for-advisory-committees-302130399.html
SOURCE U.S. Food and Drug Administration