The undersigned 57 organizations represent millions of Americans living with chronic and acute diseases — patients, caregivers, and families whose lives depend on improved treatments and the discovery of cures. We have grave concerns about the Office of Management and Budget’s proposed rule, Regulation for Federal Financial Assistance, proposed on May 29.  If allowed to become final, this rule will have profound implications on biomedical research and ultimately the patients we represent.  We respectfully ask for your leadership in ensuring this proposed rule is withdrawn and does not take effect.  

Our organizations are part of United for Cures, a collaborative network of patient advocacy organizations dedicated to protecting life-saving biomedical research that has – for decades – led the world in delivering treatments and cures to communities across the United States. Nearly every American family is touched by serious, complex and chronic illnesses that are directly impacted and can benefit from continued investment in medical research and treatments.  According to polling conducted for United for Cures in March, 95% of American voters believe it is important for the U.S. to be a global leader in medical research. 

Many organizations, including United for Cures, asked for an extension of the only 45-day comment period to ensure that the full implications of the proposed rule can be understood and discussed. Unfortunately, our requests for extension were denied. We now ask for your leadership in urging that this rule be withdrawn before it is allowed to take effect on October 1 so that Congress and the American public can fully consider its significant implications as well as the increases in federal regulation that this proposal would bring. 

While the proposed rule would cover grant-making for more than 40 different departments and agencies, our organizations are very concerned about the impact on biomedical research and the future of treatments and cures in the United States. Under this proposal:  

• Research grants could be terminated at any time, for any reason, with little to no recourse. This would leave patients participating in clinical trials without further treatment, potentially wasting millions of dollars in federal funding and taking hope away from individuals who are benefitting from cutting-edge treatments. Federal agencies can already terminate grants if there is cause; however, this rule would take away a grantee’s ability to object to, request a hearing, or appeal a termination decision in any other circumstance. The uncertainty caused by this would create a chilling effect on researchers and institutions proposing multi-year, lifesaving trials – cutting short the pipeline for discoveries and treatments.

• The U.S. would further cede the role of global scientific leader to other countries, including China. With the termination and slow spending of billions of dollars in federal research grants in the last 18 months, some of the most experienced and promising young U.S. researchers have been lured to Europe, Canada, and China; this proposed rule would likely exacerbate this, given the tight restrictions it places on international collaboration and the uncertainty around grant termination. This proposed rule would make it harder – not easier – for America’s scientists to develop the next generation of cures to compete against other countries, including China.

• Federal funding priorities could be undermined and administered in a way that is inconsistent with Congressional intent. Under its Article I authorities, Congress appropriates federal funds; the Executive Branch is to administer federal programs based on the laws passed by Congress. This proposed rule would both lock in many of the current OMB practices, including threats of pocket rescission, delaying agency funding and grant opportunities, or dramatically expanding the use of multi-year grant funding.

• Unelected, political appointees — not scientific experts — would determine which research is funded. Because this proposes to create a new federal regulation, this rule would carry forward into future administrations, adding a permanent level of politicization to science that will harm future scientific and medical developments. Tying the ability to award and — particularly — to terminate grants at will to inherently political determinations, which are likely to change from administration to administration, could result in the destabilization of the entire biomedical research system regularly.

In all, more than 300 different changes to federal grant making have been proposed that — if finalized — will have far-reaching consequences on U.S. global leadership in biomedical and scientific research for years to come.  

 Again, we urge you to push for this rule to be withdrawn so that the proposed changes can be fully understood and debated by Congress. Thank you for your continued leadership and for prioritizing the health of our country. 

Sincerely,