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December 16, 2019

Highlights from AGA’s FDA engagement

This year, AGA members and staff worked closely with representatives across the FDA on a number of key issues impacting gastroenterologists including duodenoscope reprocessing, fecal microbiota transplantation and new drug approvals for GI indications.
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AGA priority: duodenoscope safety

The issue of duodenoscope reprocessing regained national attention when a safety communication issued by the Center for Devices and Radiological Health (CDRH) was covered by the New York Times. The safety communication noted that about one in 20 samples collected from reprocessed duodenoscopes tested positive for high-concern organisms such as E. coli and Pseudomonas aeruginosa. AGA partnered with ACG, ASGE and SGNA to develop a letter to the editor and provided insights to AGA members in subsequent communications.

CDRH issued another safety communication in August recommending a transition to disposable-component duodenoscopes and convened a public advisory committee meeting in November where AGA gave public testimony including several overarching principles for the evolution of clinical practice focusing on patient safety and outcomes. AGA has been at the forefront of this issue since risk of infection transmission during ERCP first came to light in 2015, and we will continue to work closely with FDA and industry to ensure solutions, like the recently approved disposable scopes and parts, meet the needs of our members.

AGA priority: FMT regulation

Though it is not an approved therapy for Clostridioides difficile infection (CDI), FDA permits the use of fecal microbiota transplantation (FMT) for CDI unresponsive to standard antibiotic therapies under a temporary “enforcement policy” that has been in place since 2013. In response to concerns from the physician community that patient access to FMT may be discontinued once manufactured microbiota-based products come to market, AGA reengaged the Center for Biologics Evaluation and Research (CBER) in dialogue about the future of FMT through a meeting with CBER Director Peter Marks and eight senior CBER officials.

AGA requested clarification from CBER on new donor screening requirements announced for those who hold investigational new drug permits for FMT following a patient death from FMT reported in June 2019 using donor stool that was not screened for extended-spectrum beta-lactamase (ESBL)-producing E. coli.

Most recently, AGA was the only professional society to give public testimony at a November public hearing on the use of FMT to treat CDI. AGA will continue to engage CBER as the agency works to finalize its policy on FMT.

AGA priority: GI drug approvals

AGA organized two joint scientific sessions at Digestive Disease Week® 2019 with representatives from the Center for Drug Evaluation and Research’s Division of Gastrointestinal and Inborn Errors Products: the inaugural FDA Town Hall and a session on controversies around measuring drug toxicity.

The FDA Town Hall, which will continue at DDW 2020, featured four FDA speakers providing the data and rationale behind recent GI drug approvals. The session titled, “Controversies Around Measuring Drug Toxicity” gave FDA and gastroenterologists’ perspectives on 5-HT3 antagonists (e.g., alosetron) and 5-HT4 agonists (e.g., prucalopride), as well as proton pump inhibitors. These sessions aimed to promote an interchange of ideas among regulators, clinicians and pharmaceutical manufacturers to advance the development and use of new therapies for GI disorders.

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