Gastroenterology group asks FDA for more discussion on GERD guidances

The American College of Gastroenterology (ACG) has urged the US Food and Drug Administration (FDA) to consider certain inclusion and exclusion criteria when asking sponsors to conduct clinical trials for drugs to treat gastroesophageal reflux disease (GERD). The group commented on two draft guidances on the topic and asked the agency to convene public meetings to allow more dialogue before the guidances are finalized.

FDA recently published a guidance on treatments for symptomatic nonerosive gastroesophageal reflux disease (sGERD), and another one for erosive esophagitis (EE). Both guidances address issues such as eligibility criteria for clinical trials, trial design features, efficacy evaluations, and safety assessments. (RELATED: FDA issues draft guidances targeting GERD-related conditions, Regulatory Focus, 16 September 2025)

In their comment on the sGERD guidance, ACG recommended “baseline tests such as pH-metry testing for a clearer definition of the patient population, given that sGERD is a constellation of symptoms….We recommend requiring H. pylori testing for all patients prior to joining a trial to accurately interpret results, optimize analysis, as well as prescribing instructions.”

In the EE guidance, ACG asked FDA to recommend excluding LA Grade A patients and instead include them in trials for sGERD treatments. The group noted that patients with LA Grade A esophagitis can improve without treatment, as has been demonstrated in past studies using a placebo.

In both guidances, ACG asked FDA to recommend excluding patients on non-stable doses of medication that delay gastric emptying, such as glucagon-like peptide-1 (GLP-1) agonists.

ACG also addressed clinical trial designs in their letters. The group asked that the FDA provide clearer terminology and definitions of patient symptoms in the sGERD guidance, as well as define the targeted patient population and clinical criteria. In the EE guidance, the group recommended that the agency ask for a “central reader” in trials to address concerns about variability between clinical investigators.

In both guidances, ACG also recommended that FDA consider creating a pathway for longer-term safety studies in situations where there is a need to study safety effects.

Ultimately, ACG said it wants more opportunity to continue to engage with FDA on developing the GERD guidances.

“ACG recommends convening an FDA workshop, like the FDA’s Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT) Workshops that have been held in recent years, to address stakeholder comments on [these] important draft guidance(s),” said the group. “The ACG is also a member of the FDA’s Network of Experts and would also welcome the opportunity to help convening a meeting of clinical experts to discuss [these] draft guidance(s).”

Gastroenterology group asks FDA for more discussion on GERD guidances

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