Health Care Week in Review | HHS Cancels mRNA Vaccine Development Projects Under BARDA; President Trump Signs EO to Increase Oversight of Federal Grants

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news. 

 Regulations, Notices & Guidance

• On August 4, 2025, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—April through June 2025. This quarterly notice lists manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published in the three-month period, relating to the Medicare and Medicaid programs and other programs administered by CMS.
• On August 4, 2025, the National Institutes of Health (NIH) released a notice entitled, Supporting Fairness and Originality in NIH Research Applications. NIH is providing guidance to researchers on the appropriate usage of artificial intelligence (AI) to maintain the fairness and originality of NIH’s research application process. NIH is also instituting a new policy limiting the number of applications that NIH will consider per principal investigator per calendar year.
• On August 5, 2025, the Food and Drug Administration (FDA) released a proposed rule entitled, Food Standards of Identity Modernization; Pasteurized Orange Juice. FDA is proposing to amend the standard of identity for pasteurized orange juice (POJ) by lowering the minimum orange juice soluble solids content from 10.5° to 10° Brix. FDA tentatively concludes that this proposed amendment will promote honesty and fair dealing in the interest of consumers and provide industry with greater flexibility in the manufacturing of pasteurized orange juice. This action, if finalized, will respond to a citizen petition submitted by the Florida Citrus Processors Association Inc. and Florida Citrus Mutual Inc.
• On August 6, 2025, FDA released a proposed rule entitled, Requirements for Additional Traceability Records for Certain Foods: Compliance Date. FDA is proposing to extend the compliance date for the final rule, Requirements for Additional Traceability Records for Certain Foods, due to concerns about the amount of time affected entities will need to implement the requirements of the rule. If finalized, this rule would extend the compliance date by 30 months, from January 20, 2026, to July 20, 2028.
• On August 6, 2025, the Health Resources and Services Administration (HRSA) released a notice entitled, Health Center Program Performance Period Extensions. HRSA is extending health center grantees’ performance periods to a total of four years. The change from a three-year performance period to a four-year performance period will provide current health centers additional time to serve their service area before they apply for a new award and will provide a funding amount consistent with what would have been made available through the Service Area Competition (SAC). The extended performance period supports HRSA’s commitment to continuity in access to comprehensive primary care and will not impact HRSA’s ability to ensure that health centers comply with Health Center Program requirements. This update will not change the statutory requirement that health centers that fail to comply with Health Center Program requirements will receive a one-year performance period if a new project period is awarded.
• On August 6, 2025, HRSA released a notice entitled, Pediatric Mental Health Care Access Program. HRSA is announcing supplemental funding for 19 PMHCA (U4A) award recipients to continue to address the national surge in behavioral health needs among children and adolescents. These supplemental awards, funded through fiscal year (FY) 2025 appropriations, will ensure consistent support across all 29 PMHCA recipients. While ten recipients previously received forward funding, 19 did not due to availability of funds. This supplemental funding will bring parity across the program. HRSA previously provided supplemental funding to these 19 recipients for similar activities in FY 2023 and FY 2024. With this support, recipients will continue to enhance the behavioral health workforce capacity in pediatric primary care, school settings, and emergency departments to address the growing behavioral health needs among children and adolescents.
• On August 7, 2025, FDA released a notice entitled, Product-Specific Guidance on Iron Sucrose; Draft Guidance for Industry; Availability. FDA is announcing the availability of a revised draft guidance for industry entitled, Draft Guidance on Iron Sucrose. This revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for iron sucrose intravenous injectable.
• On August 7, 2025, FDA released a notice entitled, Onshoring Manufacturing of Drugs and Biological Products; Public Meeting; Request for Comments. FDA is announcing the establishment of a docket to solicit public comments on issues related to accelerating the establishment of new pharmaceutical manufacturing facilities in the U.S. FDA is also announcing the following public meeting entitled, Onshoring Manufacturing of Drugs and Biological Products. At this meeting, FDA will present a draft framework that seeks to facilitate onshoring of pharmaceutical manufacturing. Participants will then engage in a guided discussion regarding the proposed framework, its strengths, weaknesses, and opportunities. The group will also discuss additional considerations that may help overcome current challenges faced by industry to onshoring the manufacturing of pharmaceuticals. This includes active pharmaceutical ingredients (APIs) and finished drug and biological products, and ideas and options within the bounds of FDA’s statutory authority that could facilitate such onshoring of manufacturing.

Event Notices

Please note that two asterisks (**) preceding the item indicate a new event. 

• August 13, 2025: FDA announced a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. This is a virtual meeting open to the public.
• August 20, 2025: The Department of Veterans Affairs (VA) announced a meeting of the Rehabilitation Research and Development Service Scientific Merit Review Board. This is a virtual meeting with some sessions open to the public. 
• August 26-27, 2025: VA announced a meeting of the Veterans’ Advisory Committee on Rehabilitation. This is a virtual meeting open to the public.
• August 27, 2025: VA announced a meeting of the Health Systems Research Scientific Merit Review Board. This is a virtual meeting with some sessions open to the public.
• **September 3-4, 2025: NIH announced a meeting of the National Advisory Neurological Disorders and Stroke Council. This is a hybrid meeting with some sessions open to the public.
• **September 4, 2025: NIH announced a meeting of the National Institute on Alcohol Abuse and Alcoholism. This is a hybrid meeting with some sessions open to the public.
• **September 4, 2025: NIH announced a meeting of the National Cancer Advisory Board. This is a hybrid meeting with some sessions open to the public.
• September 4, 2025: NIH announced a meeting of the National Deafness and Other Communication Disorders Advisory Council. This is an in-person meeting with some sessions open to the public. 
• September 4-5, 2025: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• September 5, 2025: NIH announced a meeting of the National Advisory Council on Minority Health and Health Disparities. This is a hybrid meeting with some sessions open to the public.
• **September 9, 2025: NIH announced a meeting of the National Advisory Council for Nursing Research. This is a hybrid meeting with some sessions open to the public.
• September 9-10, 2025: NIH announced a meeting of the National Advisory Child Health and Human Development Council. This is a hybrid meeting with some sessions open to the public. 
• **September 9-10, 2025: The Centers for Disease Control and Prevention (CDC) announced a meeting of the National Center for Health Statistics ICD-10 Coordination and Maintenance Committee. This is a virtual meeting open to the public. 
• September 10, 2025: NIH announced a meeting of the National Institute of Environmental Health Sciences. This is a hybrid meeting with some sessions open to the public.
• September 10, 2025: FDA announced a meeting of the National Advisory Dental and Craniofacial Research Council. This is a hybrid meeting with some sessions open to the public.
• September 11, 2025: NIH announced a meeting of the National Advisory General Medical Sciences Council. This is a virtual meeting with some sessions open to the public.
• September 11-12, 2025: HRSA announced a meeting of the Council on Graduate Medical Education. This is a hybrid meeting open to the public.
• **September 11-12, 2025: NIH announced a meeting of the Council of Councils. This is a hybrid meeting with some sessions open to the public. 
• September 11-12, 2025: NIH announced a meeting of the National Institute of Environmental Health Sciences. This is a hybrid meeting open to the public.
• September 16, 2025: NIH announced a meeting of the National Human Genome Research Institute. This is a hybrid meeting open to the public.
• September 17-18, 2025: NIH announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases. This is a hybrid meeting with some sessions open to the public.
• September 17-18, 2025: NIH announced a meeting of the National Institute on Aging. This is a virtual meeting with some sessions open to the public.
• **September 18, 2025: NIH announced a meeting of the National Center for Advancing Translational Sciences. This is a hybrid meeting with some sessions open to the public.
• **September 19, 2025: NIH announced a meeting of the National Advisory Council for Complementary and Integrative Health. This is a hybrid meeting with some sessions open to the public.
• September 25, 2025: NIH announced a meeting of the National Institute of Allergy and Infectious Diseases. This is a virtual meeting open to the public.
• **September 30, 2025: NIH announced a meeting of the Diabetes Mellitus Interagency Coordinating Committee. This is a virtual meeting open to the public.
• October 7, 2025: FDA announced a meeting of the Tobacco Products Scientific Advisory Committee. This is a hybrid meeting open to the public. 
• October 8-9, 2025: NIH announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases. This is a hybrid meeting with some sessions open to the public.
• October 27-28, 2025: NIH announced a meeting of the Board of Regents of the National Library of Medicine. This is a virtual meeting with some sessions open to the public.
• **October 27-29, 2025: NIH announced a meeting of the Board of Scientific Counselors of the National Institute on Aging. This is a hybrid meeting with some sessions open to the public.
• December 1-2, 2025: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting open to the public.
• December 4-5, 2025: HRSA announced a meeting of National Advisory Council on Nurse Education and Practice. This is a hybrid meeting open to the public.
• December 5, 2025: NIH announced a meeting of the Board of Scientific Counselors Eunice Kennedy Shriver NICHD. This is a hybrid meeting with some sessions open to the public.
• March 30-31, 2026: NIH announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases. This is a hybrid meeting with some sessions open to the public.

Reports, Studies & Analyses

• On August 4, 2025, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a report entitled, Analysis of Selected Nursing Facilities’ Use of Medicaid Reimbursement for Direct Care Compensation. OIG analyzed spending for 26 nursing facilities in 2018 and 2021 to assess: (1) the percentage of funds received through Medicaid reimbursement that the facilities spent on direct care compensation; (2) whether the percentage used for direct care compensation at each facility changed between 2018 and 2021; and (3) whether that change was a result of new ownership. The analysis found that between 2018 and 2021, 17 facilities increased the percentage of Medicaid funds spent on direct care compensation, while nine facilities decreased spending over the same period. Notably, 12 of the 17 facilities that increased spending also experienced a decline in nursing hours per resident day. OIG identified two nursing facilities that changed ownership between 2018 and 2021. While the analysis did not identify a direct correlation between higher Medicaid spending on direct care compensation and increased nursing hours per resident day, it suggests that other factors may impact the quality of care provided by nursing facilities.
• On August 5, 2025, HHS OIG released a report entitled, Medicare Part B Drug Payments: Impact of Price Substitutions Based on 2023 Average Sales Prices. OIG reviewed how CMS applied its price-substitution policy to drugs whose market prices exceeded a set threshold. Since 2013, CMS has implemented price substitutions for 91 drugs identified by OIG, resulting in $76 million in savings for Medicare and its enrollees. Price substitutions were applied to 20 drugs in 2023, resulting in $1.6 million in savings. However, OIG noted that potential errors in manufacturer-submitted pricing data prevented evaluation of 35 additional drugs. OIG has notified CMS of such discrepancies and encourages further collaboration with manufacturers to improve data accuracy and ensure the effectiveness of the price-substitution policy.
• On August 6, 2025, KFF released a report entitled, How Much and Why ACA Marketplace Premiums Are Going Up in 2026. The report analyzed insurers’ initial rate filings for Affordable Care Act (ACA) Marketplace plans in all 50 states and D.C. The median proposed increase for 2026 is 18 percent, approximately 11 percent higher than last year’s proposed increase. Insurers cited rising health care prices, increased utilization of high-cost drugs, inflation, and labor costs as significant factors in their rate hikes for next year. Many filings also reflect the anticipated expiration of enhanced premium tax credits, which the analysis notes could raise out-of-pocket costs for enrollees by over 75 percent and lead to coverage losses among healthier individuals, further driving up premiums.

Other Health Policy News

Protecting Healthcare and Lowering Costs Act Introduced

On August 4, 2025, Senators Ron Wyden (D-OR), Chuck Schumer (D-NY), Jeanne Shaheen (D-NH), Jeff Merkley (D-OR), and Ben Ray Luján (D-NM) introduced the Protecting Healthcare and Lowering Costs Act, which would reverse recent health care cuts enacted in the One Big Beautiful Bill Act (H.R. 1) and make permanent the premium tax credits under the ACA. The bill specifically targets Subtitle B of Title VII of H.R. 1, which, in part, imposes Medicaid work requirements, tightens eligibility for ACA subsidies, and bars undocumented and certain lawfully present immigrants from accessing federal health programs. In addition to reversing these provisions, the Protecting Healthcare and Lowering Costs Act would permanently extend ACA premium tax credits by removing the income cap and establishing a sliding scale for contributions based on income. The bill was introduced in response to the enactment of H.R. 1, which reduces health care spending by one trillion dollars and, according to the Congressional Budget Office (CBO) estimates, would result in 10 million more people being uninsured.

The text of the bill is available here. Press release is available here. CBO estimates are available here.

NIH Found to Have Violated Impoundment Control Act of 1974

On August 5, 2025, GAO issued a decision concluding that NIH violated the Impoundment Control Act of 1974 (ICA) by withholding funds that had been appropriated by Congress for FY 2025. The decision followed a review of NIH’s actions in response to several executive orders (EOs), which led to the cancellation of existing grants and a pause in the publication of grant review meeting notices in the Federal Register. GAO found that these actions resulted in a reduction in NIH’s awarding of new grants and a decline in its obligations and expenditures. Based on publicly available data and the absence of a special message from the President to Congress, GAO determined that NIH withheld budget authority from obligation and expenditure without following the procedures required under the ICA.

Under the ICA, the executive branch may only withhold funds under limited circumstances and must notify Congress through a formal rescission proposal or other legislative action. GAO emphasized that unless Congress enacts a law providing otherwise, executive officials are required to “prudently obligate” appropriations during their period of availability.

In response, HHS, which oversees NIH, stated that it had lifted the pause on Federal Register submissions and resumed scheduling grant review meetings. However, HHS did not provide information on NIH’s current obligations for FY 2025 and did not offer sufficient justification for the earlier pause.

The full text of GAO’s report is available here.

HHS Terminates mRNA Vaccine Development Activities

On August 5, 2025, HHS Robert F. Kennedy, Jr. announced the termination of all 22 of the agency’s mRNA vaccine development activities under the Biomedical Advanced Research and Development Authority (BARDA), affecting nearly $500 million in contracts and proposals. The decision follows a comprehensive review of mRNA-related investments initiated during the COVID-19 public health emergency, through which HHS determined that mRNA vaccines fail to effectively protect against upper respiratory infections like COVID-19 and influenza. In its announcement, HHS stated that future vaccine development activities under BARDA will focus on platforms with stronger safety records and transparent clinical and manufacturing data practices. 

The HHS press release announcing the decision can be found here.

Executive Order Establishes New Requirements for Reviewing and Approving Discretionary Grants

On August 7, 2025, President Trump signed an EO entitled, Improving Oversight of Federal Grantmaking, which establishes new requirements for reviewing and approving discretionary grants. The EO directs agencies to designate political appointees responsible for overseeing funding opportunity announcements and discretionary awards to verify that grants “benefit the American public” and align with Administration priorities. The EO mandates interagency coordination to reduce duplication and requires plain-language application materials to simplify funding announcements. The EO outlines specific prohibitions on funding activities that promote racial discrimination, deny the “sex binary,” support “illegal immigration,” or advance “anti-American values.” It also calls for prioritizing institutions with lower indirect cost rates. The EO authorizes the Office of Management and Budget (OMB) to revise the Uniform Guidance to streamline application requirements and allow for termination of grants that no longer serve agency priorities or the “national interest.” Agencies must also revise existing grant terms to permit termination for convenience and require grantees to justify drawdowns with specific documentation. 

The EO can be found here. The EO fact sheet can be found here. 

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