Foundation Fighting Blindness urges withdrawal of new federal funding rule to prioritize patient health

The Foundation Fighting Blindness is the world's leading private funder of research into inherited retinal diseases and dry age-related macular degeneration (dry AMD). Over fifty years of strategic investments, we have helped advance numerous scientific discoveries from the laboratory into clinical development, including research that ultimately contributed to the first FDA-approved gene therapy for an inherited disease. Our mission depends upon a strong partnership among private philanthropy, academic institutions, biotechnology companies, and federal research agencies.

For patients living with blinding inherited retinal diseases and dry AMD—many of whom have no approved treatment and face irreversible vision loss—predictability in the federal research system directly affects whether promising therapies reach patients.

The Office of Management and Budget’s proposed rule, Regulation for Federal Financial Assistance, fundamentally alters the longstanding framework governing federal financial assistance in ways that would undermine the biomedical research enterprise, create substantial uncertainty for research institutions and patient organizations, and jeopardize the public-private partnerships that have driven decades of medical innovation.

Because these changes will ultimately hurt patients awaiting new treatments to slow down or reverse vision loss, we respectfully urge OMB to preserve scientific peer review as the primary basis for awarding biomedical research grants.

As written, the proposed rule would implement the following changes:

• Upend merit-based scientific review by authorizing additional political review of awards that have already undergone rigorous scientific evaluation and the ability to change agency priorities after completing the peer-review process.
• Allow for ad-hoc termination of awards, permitting agencies to terminate discretionary awards when they decide that doing so serves agency priorities or the national interest, instead of terminating awards based on scientific performance or recipient compliance.
• Weaken public-private research partnerships that drive rare disease research by introducing uncertainty into federal funding. Rare disease research typically has limited commercial incentives and instead relies on private investments, which in turn look to federal funding for certainty.
• Put congressional funding for research at odds with presidential policy. It is unclear what happens when presidential priorities are not aligned with the funding Congress has already appropriated for disease-specific research programs.

The proposed revisions represent some of the most significant changes to the federal grants framework in many years and would affect nearly every recipient of federal financial assistance. They carry implications for universities, non-profits, patient advocacy organizations, research institutions, and federal agencies. Changes have the potential to disrupt ongoing clinical research involving patients and delay development of therapies for rare diseases where only a handful of research programs may exist.

Patients with inherited retinal diseases and dry AMD depend on a stable, predictable, and scientifically driven federal research enterprise. Given the major implications of the proposed rules, Foundation Fighting Blindness has submitted comments to OMB requesting that they withdraw the proposed rule and, if additional reforms are deemed necessary, engage stakeholders through a new rulemaking process that preserves merit-based scientific review, respects congressional intent, and strengthens—not weakens—the research ecosystem that is essential to delivering new therapies to patients.

While the public comment submission period to the OMB rule is formally closed, there is still time to contact your elected representative with concerns about how the proposed rule impacts the scientific enterprise and what it means for patients who rely on it to develop new treatments.

Read our full comments here.