The Alliance for mRNA Medicines (AMM) submitted comments to the Office of Management and Budget (OMB) on July 13, 2026, responding to OMB’s proposed rule, “Regulation for Federal Financial Assistance“(OMB-2026-0034; 91 Fed. Reg. 32198). In its comments, AMM asked OMB to withdraw the proposal or substantially revise it because of our concern that several provisions of the proposed rule would fundamentally disrupt the federal research enterprise.
Importance of mRNA Research
“The mRNA field illustrates why stable, merit-based federal research policy matters. Breakthroughs in mRNA chemistry, delivery systems, immunology, lipid nanoparticle technology, manufacturing, and clinical translation emerged from decades of sustained research across universities, government laboratories, nonprofit institutions, and industry. These advances have strengthened pandemic preparedness, accelerated vaccine development, and created opportunities for new therapeutic modalities. Federal grants and cooperative agreements play a central role in sustaining this ecosystem, particularly for early-stage and high-risk research that private capital may not support on its own.”
Harmful Effects of Proposed Rule
“If finalized without substantial revision, the rule would unintentionally weaken the United States’ biomedical innovation ecosystem by introducing uncertainty for multi-year research, jeopardize merit-based scientific review, reduce scientific independence, restrict dissemination of research findings, impede necessary scientific collaboration, and discourage long-term public-private partnerships that have made the United States the global leader in medical research and biotechnology.”
“As drafted, the proposed rule would move federal research policy in the opposite direction. It would introduce uncertainty into funding decisions, weaken confidence in merit-based review, destabilize active research, restrict dissemination of findings, and impede collaborations that support U.S. scientific leadership and public health.”
AMM’s Recommendations for the Final Rule:
- Preserve peer review as the central determinant of scientific merit and require clear, transparent, science-based justification when agencies depart from peer-review recommendations.
- Limit termination authority to well-defined circumstances, such as material noncompliance, documented poor performance, fraud, waste, safety concerns, or statutory changes, and provide meaningful notice and appeal rights for recipients.
- Maintain allowability of reasonable publication, conference, professional development, membership, subscription, and dissemination costs that are necessary to conduct and communicate federally funded research.
- Extend implementation timelines and engage meaningfully with scientific agencies, research institutions, patient organizations, industry stakeholders, and the public before making any major structural changes to the federal research funding system.
Read the full comments here.