APFED Statement on Disqualification of CEGIR Renewal Application

We have received a most discouraging notification that the critical research being conducted by the Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR, Grant 3U54AI117804), funded by National Institutes of Health, has come to an abrupt halt. APFED, the patient community, scientists and doctors have poured their hearts and dollars into making CEGIR the successful research consortium it is today. The consequences of this decision will fall hardest on patients and their families, particularly children, who face the greatest burden of disease. The disruption of this research risks significant setbacks in care, with serious and lasting impacts on health and quality of life.

CEGIR brings together some of the most brilliant and dedicated scientists across the United States, working collaboratively with patient advocates to advance research into eosinophilic gastrointestinal diseases (EGIDs). For 11 years, CEGIR has operated with funding from the National Institutes of Health (NIH) through the Rare Diseases Clinical Research Network. During that time, APFED has awarded significant supplemental funding—using contributions from patients and families themselves—to further support CEGIR’s vital work.

The decision to disqualify CEGIR’s reapplication for funding consideration is not the result of scientific failure or merit. Rather, it results from administrative decisions tied to newly implemented federal policies and the sudden enforcement of regulations that had neither been previously applied nor clearly communicated.

The consequences are devastating: the sudden end to CEGIR’s clinical trials and the halt of disease-specific research. Eosinophilic gastrointestinal diseases have no clearly defined cause, yet they lead to lifelong, often severe illness. The impact on those affected is profound, marked by significant suffering, loss of intestinal function, and diminished quality of life. Patients and families living with rare and chronic EGIDs are directly and immediately harmed by this disruption. These individuals depend on sustained, science-driven progress to bring hope, relief, and the possibility of effective treatment.

Most EGID subtypes still lack a single FDA-approved therapy. CEGIR’s research has already begun to change that outlook in meaningful ways. To bring this work to an abrupt and unnecessary end, with limited regard for its human cost, is a setback with lasting consequences for the rare disease community.

The decision to disqualify CEGIR’s application for renewed funding is a devastating blow to the patients and families CEGIR was created to help. Lives are put on hold, opportunities for breakthrough treatments are lost, and years of trust in the research system are shaken.

Our community deserves better. Patients should not be casualties of shifting administrative policies.

For years, the U.S. Congress has long-recognized the impact of eosinophilic diseases. In 2007, the House of Representatives passed HR 296, formally designating the third week of May as National Eosinophil Awareness Week. In 2013, Senate report language in the HHS appropriations bill requested an NIH update on eosinophilic disease research initiatives, referencing a pivotal publication (Bochner BS, Book W, Busse WW, et al. J Allergy Clin Immunol, 2012;130(3):587–596) that helped guide research priorities for eosinophil-associated disorders.

CEGIR’s progress over the past 11 years has been extraordinary. In 2022, the first FDA-approved treatment for eosinophilic esophagitis (EoE) became available, thanks in part to research supported by NIH. This is the kind of progress now at risk. CEGIR’s clinical trials and research programs have generated essential data that has provided the foundation for treatment guidelines and supported FDA approvals. CEGIR’s long-term natural history study and trials evaluating emerging therapies are crucial to advancing care and improving outcomes. The CEGIR Trainee Program is vital for developing the next generation of clinician-researchers focused on EGIDs, ensuring continued innovation and improved care for patients with these rare and complex conditions.

We are deeply disappointed by the abrupt shutdown of more than a decade’s worth of groundbreaking work due to shifting administrative directives. APFED supports the responsible use of taxpayer dollars and CEGIR has delivered exceptional returns on investment in the form of diagnostic advancements, treatment development, and improved patient care.

We urge federal leaders and policymakers to consider the real-world consequences of these decisions. We call on Congress to act swiftly and decisively to protect vulnerable Americans—patients with rare diseases—who are left to suffer as vital research initiatives are shut down without warning or recourse.

APFED stands in solidarity with the individuals and families affected by this decision and will continue to advocate for transparency, consistency, and unwavering support for scientific discovery that puts patients first. We vow to continue efforts to move research forward until every patient who suffers from eosinophil-associated disease has access to an FDA-approved therapy.

Issued by the American Partnership for Eosinophilic Disorders (APFED)

Related Press Release

Action needed by Tuesday, April 22!

Visit Congress.gov to look up who represents you and how to contact them. Given the urgent nature, phone calls may garner the fastest attention, but any communication is helpful. Urge your Congressional members to ask the NIH to facilitate a fair scientific review of U54 renewal applications.

SAMPLE MESSAGE: 

Subject: Urgent: Please Help Reinstate a Critical Research Grant for Eosinophilic Diseases

Dear [Senator/Representative Name],

I am a [briefly introduce yourself: e.g., parent of a child with an eosinophilic gastrointestinal disease in [Your State], patient living with EoE, etc.]. I’m writing to express my deep concern about an urgent issue affecting federally funded research for rare diseases like mine.

The renewal application for the Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR), grant 3U54AI117804, was recently denied the opportunity for scientific review due to an administrative oversight tied to newly enforced NIH submission rules. Unless action is taken, this decision could permanently halt over a decade of progress in treating eosinophilic gastrointestinal diseases (EGIDs).

I respectfully urge you to:

• Request that NIH reinstate the U54 renewal applications so they may undergo full scientific review.

• Ensure that NIH grants missing the newly required Foreign Justification attachment are still reviewed, and not automatically disqualified without fair consideration.

For more than ten years, CEGIR has led groundbreaking research, supported FDA approvals, and shaped clinical guidelines that improve care for tens of thousands of Americans living with EGIDs. The consortium’s work has been a lifeline to families like mine. Its abrupt disruption risks undoing critical progress and delaying desperately needed treatment options.

Please help protect this vital research by encouraging NIH Director Dr. Jay Bhattacharya to reinstate U54 renewal applications, like CEGIR’s proposal 3U54AI117804) for scientific review before April 22 NIH Final Scientific Review meeting.

Thank you for your time and for standing with patients who live with rare, chronic diseases.

Sincerely,
[Your Full Name]
[Your City, State]
[Optional: Your email or phone number]