FDA Announces Draft Guidance for Celiac Therapies

From ACG FDA Related Matters Committee Chair, Eric D. Shah, MD, MBA, FACG

The U.S. Food and Drug Administration (FDA) recently announced draft guidance for industry entitled “Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet.”

This draft guidance addresses FDA’s recommendations regarding clinical trials for drugs being developed for the treatment of celiac disease as an adjunct to a gluten-free diet in adults. The ACG FDA Related Matters Committee is reviewing the guidance and continues to work with FDA staff on behalf of ACG members and clinical gastroenterology.

The FDA also announced the draft guidance for industry entitled “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.” The purpose of this guidance is to provide recommendations to sponsors developing medical products on the approach for developing a Race and Ethnicity Diversity Plan (referred to as the “Plan”) to enroll adequate numbers of participants in clinical trials from underrepresented racial and ethnic populations in the U.S.

ACG NAAN Staying Busy On Capitol Hill

From ACG Legislative and Public Policy Council Chair, Louis J. Wilson, MD, FACG

Recently, ACG Governor for Northern New Jersey, Sita Chokhavatia, MD, MACG, and ACG National Affairs Action Network (NAAN) member, David Truscello, DO, met with Rep. Bonnie Watson Coleman (D-NJ). We discussed the importance of protecting and supporting ACG members and physician practices across the U.S. As we discussed during the ACG Advocacy Day, physician practices are stressed and stretched. She looks forward to working with the College this year.

Working with Congress, the ACG NAAN and Board of Governors strive to increase access to care and decrease these burdens unfairly borne by GI practices. ACG will continue to serve as your voice for clinical gastroenterology and our patients on Capitol Hill and in state Houses across the country.

Other Notable Highlights for ACG Members

On April 12th, the Department of Health and Human Services (HHS) extended the COVID-19 public health emergency (PHE) for an additional 90 days. The extension of the PHE means that GI practices will continue to be able to leverage the COVID-19 waivers and regulatory flexibilities, such as telehealth. The Administration has indicated that they will provide a notice in advance of 60 days when they plan to end the PHE.

The Centers for Disease Control and Prevention (CDC) on April 21 issued a health alert to notify clinicians and public health authorities of a cluster of children identified with hepatitis and adenovirus infection. In November 2021, clinicians at a large children’s hospital in Alabama notified the CDC of five pediatric patients with significant liver injury, including three with acute liver failure, who also tested positive for adenovirus. All children were previously healthy. None had COVID-19. Case-finding efforts at this hospital identified four additional pediatric patients with hepatitis and adenovirus infection for a total of nine patients admitted from October 2021 through February 2022. The CDC recommends that U.S. clinicians encountering pediatric patients with hepatitis of unknown etiology to consider adenovirus testing and to report cases to state public health authorities and to the CDC.

On Wednesday, April 20th, the Centers for Medicare & Medicaid Services (CMS) released data on hospital mergers, acquisitions, consolidations, and changes of ownership from 2016-2022. The goal is for the public to better understand the impacts of consolidation on health care prices and quality of care. Click here to access the CMS data files. CMS expects to release updated data on a quarterly basis. HHS’s Office of the Assistant Secretary for Planning and Evaluation (ASPE) also just released new analysis examining trends in changes of ownership over the past six years.

CMS opened the Federal Independent Dispute Resolution (IDR) process for providers, facilities, and health plans and issuers to resolve payment disputes for certain out-of-network charges. HHS will give disputing parties whose open negotiation period expired before April 15, 2022 an extended 15 business days to file an initiation notice via the IDR Portal.

The Biden Administration recently announced new actions to protect consumers and lessen the burden of medical debt. HHS will be collecting data from 2,000 hospitals and providers related to debt collection practices and patient payment options. According to the statement, HHS will publish topline data and policy recommendations for the public, and share potential violations with the relevant enforcement agencies of jurisdiction. Separately, the Consumer Financial Protection Bureau (CFPB) will investigate credit reporting companies and debt collectors that violate patients’ and families’ rights, and hold violators accountable.