FDA Related Matters Committee

MEMBERS

Eric D . Shah, MD, MBA, FACG, Chair George G . Abdelsayed, MD, FACG Dawn M . Beaulieu, MD Kendall R . Beck, MD Kalyan R . Bhamidimarri, MD, MPH, FACG Shrinivas Bishu, MD James B . Canavan, MD, PhD Amanda K . Cartee, MD Saurabh Chawla, MD, FACG Jacqueline N . Chu, MD H . Matthew Cohn, MD Parakkal Deepak, MD, FACG Linda A . Feagins, MD, FACG Martin I . Golding, MD, FACG Lawrence Goldkind, MD Paul Guarino, MD, FACG Stephen Hasak, MD Yasmin G . Hernandez-Barco, MD Justin T . Kupec, MD, FACG Vladimir M . Kushnir, MD Benjamin H . Levy, III, MD Jasbir S . Makker, MD, FACG Suresh Kumar Nayudu, MD, FACG Young Oh, MD, MS Harini Rathinamanickam, MD Fayez S . Sarkis, MD Jason N . Schairer, MD Adam F . Steinlauf, MD Eric J . Vargas, MD Shivakumar Vignesh, MD, FACG

Eric D. Shah, MD, MBA, FACG

RESPONSIBILITIES AS STATED IN THE ACG BYLAWS

This Committee shall be responsible for maintaining and strengthening the College’s relationship with the Food and Drug Administration (FDA), as well as providing topical information to The American Journal of Gastroenterology and other ACG publications and meetings regarding GI drugs and devices that have been reviewed and/or approved by the FDA .

OBJECTIVES

1 . Maintain and enhance an ongoing relationship with the U .S .

Food and Drug Administration (FDA): • To serve in an advisory role concerning gastroenterology products . • To assess impact of FDA decisions regarding drugs/devices and to inform ACG leadership and members . • To provide suggestions for the FDA GI Drug Advisory Committee . • To develop and maintain collaborative programs with the FDA . 2 . Provide updates, via The American Journal of

Gastroenterology, SmartBrief, the ACG website, other media, and workshops or symposia, for our members on key issues stemming from FDA policies or decisions . 3 . Serve as a resource for members to report adverse events (AEs) more easily .

The FDA Related Matters Committee in 2021 is under the leadership of Chair Eric Shah, MD, MBA, FACG .

COMMITTEE REPORT The ACG-FDA Fellowship Program

Due to COVID-19, the ACG-FDA fellowship program was put on hold . The Committee hopes to resume the application process in the summer of 2021 .

In October 2012, the ACG Board of Trustees approved the creation of the ACG-FDA GI Fellows Program . The program provides funding to support up to two fellows to participate each year along with a stipend to attend the ACG Annual Meeting to present and discuss the fellow's experiences .

The Committee annually reviews applications and selects candidates for this ACG-FDA Fellowship Program .

The fellow(s) will subsequently become a member of the FDA Related Matters Committee .

FDA Network of Experts

The College is also a member-organization of the FDA’s “Network of Experts .” This program is a vetted network of partner organizations and their member scientists, clinicians and engineers who can provide the FDA rapid access to expertise when it is needed to supplement existing knowledge and expertise within the Center for Devices and Radiological Health (CDRH) and the Center for Drug Evaluation and Research (CDER) .

FDA RELATED MATTERS COMMITTEE (cont .)

ACG Sponsorship of FDA GREAT VI Conference

The ACG was recently invited to participate and cosponsor the recent FDA Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT) Workshop in July 2021 . This two-day workshop focused on eosinophilic gastrointestinal disorders and celiac disease . ACG has co-hosted the conference with the FDA and other organizations in previous years as well .

Committee Workshops at the ACG Annual Meeting

The Committee holds ACG-FDA joint workshops at the ACG Annual Meeting, including events discussing endpoints for IBD, EoE, bowel preparation products, and biologic drugs/biosimilars in IBD . The Committee is currently planning this session jointly with the ACG Innovation & Technology Committee, focusing on artificial intelligence in gastroenterology .

FDA Committee Manuscripts

The Committee routinely drafts manuscripts related to the FDA and clinical gastroenterology . These manuscripts are published in the Red Section of The American Journal of Gastroenterology or hosted on the FDA Committee section of the ACG website .

FDA Employees Participating in Committee Activities

While ACG has regular contact with the FDA and is often invited to participate in FDA-related events, the Committee would like to bolster this collaborative relationship with the FDA in 2021 . The Committee will begin inviting FDA employees to participate in committee calls and meeting, helping to serve as a special-advisor role to vet and recommend committee activities .

FDA Safety Alerts & Meetings

The Committee continues to highlight and notify ACG members when the FDA publishes safety alerts and other regulatory updates pertaining to clinical gastroenterology . ACG notifies membership through various communications tools and social media . The ACG FDA Related Matters Committee continues to host these safety alerts and recalls on ACG’s website .

Committee members continue to monitor and attend important hearings at the FDA on behalf of the College .