Health Care Week in Review | White House Announces Dismissal of CDC Director; DHS Issues Proposed Rule Shortening Duration of Academic Visas

Highlight of the Week

This week, Dr. Susan Monarez was removed from her role as CDC Director by the White House, and DHS proposed to replace “duration of status” with a fixed term for academic visas, including those for graduate students and postdoctoral researchers.

Regulations, Notices & Guidance

• On August 26, 2025, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a notice entitled, Fiscal Year (FY) 2025 Notice of Supplemental Funding Opportunity. SAMHSA is supporting administrative supplements in scope of the parent award for the 59 eligible Community Mental Health Services Block Grant (MHBG) recipients funded under the federal fiscal year (FFY) 2024-2025 Combined Block Grant Application. The distribution of MHBG funds, including funds allocated for technical assistance, must adhere to a statutory formula. The formula considers the population at risk, the cost of providing services, and other relevant factors. To comply with these requirements, technical assistance funds will be distributed to states and territories using this established formula. These awards have a project end date of September 30, 2026.
• On August 27, 2025, the Food and Drug Administration (FDA) released a notice entitled, Issuance of Priority Review Voucher; Rare Pediatric Disease Product; MODESYO (dordaviprone). FDA is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that MODESYO (dordaviprone), approved on August 6, 2025, manufactured by Chimerix, Inc., meets the criteria for a priority review voucher.
• On August 27, 2025, FDA released a notice entitled, Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement. FDA is announcing the fourth year of the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP). This program facilitates the expedited CMC development of products under an investigational new drug application (IND) based on the anticipated clinical benefit of earlier patient access to the products. FDA has implemented this pilot program to assist with CMC readiness for products regulated by the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) that have accelerated clinical development timelines. To accelerate CMC development and facilitate CMC readiness, the pilot features increased communication between FDA and sponsors and explores the use of science- and risk-based regulatory approaches, as applicable. This notice outlines the eligibility criteria and process for submitting a request to participate in the pilot.
• On August 28, 2025, the Health Resources and Services Administration (HRSA) released a notice entitled, Notice of Supplemental Funding; Autism Longitudinal Data Project and Linking the Boston Birth Cohort and Pregnancy to Health Databases: A Longitudinal Cohort of Mother-Child Dyads. HRSA is announcing supplemental award funds through the Patient-Centered Outcomes Research Trust Fund to the current HRSA award recipient to build further data capacity under the Autism Longitudinal Data Project. The funding will support the multi-agency data linkage project linking existing datasets to create a comprehensive longitudinal dataset. Supplemental funding was previously awarded in fiscal year (FY) 2024 for the initial phase of the project, which started in July 2024. This award will continue that work.
• On August 28, 2025, FDA released a notice entitled, Advisory Committee; Arthritis Advisory Committee; Termination; Removal from List of Standing Committees. FDA is announcing the termination of the Arthritis Advisory Committee. Due to that termination, this final rule removes the Arthritis Advisory Committee from FDA’s list of standing advisory committees in 21 CFR 14.100.

Event Notices

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

• September 3-4, 2025: The National Institutes of Health(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, 2025: NIH announced a meeting of the National Council on Drug Abuse. 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 10, 2025: FDA announced a workshop entitled, Lessons Learned From the Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Public Workshop. This is a virtual workshop 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, 2025: NIH announced a meeting of the National Institute of Mental Health. 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 15, 2025: The Department of Veterans Affairs (VA) announced a meeting of the National Research Advisory Council. 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 16-17, 2025: CDC announced a meeting of the Association of Public Health Laboratories (APHL). This is a virtual 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 18, 2025: FDA announced a meeting entitled, Biosimilar User Fee Act (BsUFA) III Regulatory Science Program Interim Public Meeting. This is a hybrid meeting open to the public.
• **September 18, 2025: CDC announced a meeting of the Advisory Committee on Immunization Practices. This is a virtual meeting open to the public.
• **September 18-19, 2025: FDA announced a public workshop entitled, Patient-Focused Drug Development: Workshop #2 to Discuss Methodologic and Other Challenges Related to Patient Experience Data. This is a virtual meeting 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 19, 2025: FDA announced a public workshop entitled, Advancing the Development of Interchangeable Products: Identifying Future Needs. This is a hybrid workshop open to the public.
• September 24, 2025: FDA announced a meeting entitled, Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment. This is a hybrid meeting 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.
• September 30, 2025: FDA announced a meeting entitled, Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments. This is a hybrid meeting open to the public.
• October 3, 2025: NIH announced a meeting of the National Eye Institute. This is a virtual meeting with some sessions open to the public.
• October 7, 2025: NIH announced a meeting of the Office of the Director. This is a virtual 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 15-16, 2025: NIH announced a meeting of the National Library of Medicine Board of Scientific Counselors. 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.
• November 16-18, 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.
• 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 a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. 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.
• June 5, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting with some sessions open to the public.

Reports, Studies & Analyses

• On August 26, 2025, the Government Accountability Office (GAO) released a report entitled, Medical Abortion: Action Needed to Ensure Compliance with Medicaid Drug Rebate Program. GAO found that 13 Medicaid programs did not cover Mifeprex and its generic equivalent, Mifepristone Tablets (200 mg), despite federal requirements mandating coverage of FDA-approved drugs from manufacturers participating in the Medicaid Drug Rebate Program (MDRP). The Centers for Medicare & Medicaid Services (CMS) was not aware of the coverage gaps in nine programs that excluded both drugs for any medical indication and four other programs that excluded the drugs specifically for medical abortion. GAO reiterated its 2019 recommendation for CMS to enforce MDRP compliance for Mifeprex and stated that CMS evaluate and ensure coverage of Mifepristone Tablets.
• On August 28, 2025, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a report entitled, Most Health Centers Provide Some Behavioral Health Services to Patients With Substance Use Disorder, Despite Facing Challenges That Limit Comprehensive Treatment. OIG found that in 2022, 90 percent of HRSA-funded health centers offered at least one behavioral health service to patients with substance use disorder (SUD), while 56 percent provided comprehensive treatment. Specifically, 88 percent offered mental health treatment, 69 percent provided drug counseling, and 72 percent administered at least one FDA-approved medication for opioid use disorder (MOUD). Over one-third of centers faced challenges working with external providers, and many reported workforce and financial barriers. OIG recommended that HRSA take additional steps to help health centers overcome obstacles to providing drug counseling and MOUD.
• On August 28, 2025, HHS OIG released a report entitled, Billing for Remote Patient Monitoring in Medicare. The report highlights the continued growth of remote patient monitoring (RPM) services in Medicare, with payments surpassing $500 million in 2024. RPM enables patients to automatically collect and transmit health data to providers using connected medical devices. To identify medical practices with billing for remote patient monitoring that warrant further scrutiny, OIG developed billing oversight measures such as flagging practices that bill for patients with no prior history or for multiple devices per enrollee. These tools aim to help CMS and Medicare Advantage (MA) organizations ensure beneficiaries benefit from RPM while maintaining program integrity.

Hearings & Markups

• On August 25, 2025, HHS issued a final rule terminating the NIH Minority Biomedical Research Support (MBRS) program, a grant program intended to increase the number of minority faculty and students engaged in biomedical research. The rule states that the MBRS program’s use of racial classifications in awarding federal funding violates the Equal Protection Clause and Title VI of the Civil Rights Act, as interpreted in the Supreme Court’s 2023 decision in Students for Fair Admissions v. Harvard. HHS cited the MBRS program’s reliance on minority student enrollment to determine applicant eligibility and added that the termination aligns with Executive Orders (EOs) issued by the Trump Administration that prevent federal agencies from supporting diversity, equity, and inclusion-related activities. The agency bypassed the notice-and-comment process, stating that notice-and-comment procedures for the final rule are “impractical, unnecessary, and contrary to the public interest.” The final rule can be found here.
• On August 27, 2025, the Department of Homeland Security (DHS) issued a proposed rule that would limit academic visa authorizations for F, J, and I visa holders to a period of up to four years, replacing the current “duration of status” policy. DHS cited concerns about visa abuse and national security risks associated with indefinite stays. Under the proposed rule, the visa holders would need to apply for an extension of status if their academic or professional activities exceed the initial authorized period. DHS stated that the change would improve oversight and reduce the number of individuals remaining in the U.S. without regular vetting. This proposed rule could affect the recruitment and retention of foreign graduate students and postdoctoral researchers, particularly those in programs that typically exceed four years.
  
  The proposed rule is open to public comment until September 29, 2025. The text of the proposed rule can be found here. A press release from DHS on the proposed rule can be found here.
• On August 27, 2025, HHS Secretary Robert F. Kennedy, Jr. announced a new federal initiative to implement comprehensive nutrition education throughout the U.S. medical training system. Supported by Department of Education (ED) Secretary Linda McMahon, the effort is part of the Trump’s Administration’s Make America Healthy Again (MAHA) agenda and aims to correct what Secretary Kennedy called a “critical disconnect” in medical education. The initiative will require nutrition instruction across six key stages: pre-medical education, medical school curricula, licensing exams, residency programs, board certification, and continuing education. In the announcement, Secretary Kennedy emphasized that poor diet contributes to seven of the ten leading causes of death in the U.S., claiming an estimated one million lives annually and driving over $4 trillion in healthcare spending. As part of this initiative, HHS directed medical schools to submit detailed plans outlining how they will meet new nutrition education standards by September 10, 2025. The reforms are expected to impact more than 200 medical schools, 13,000 residency programs, and the 1.1 million practicing physicians in the U.S.
  
  A press release is available here.
• On August 27, 2025, Dr. Susan Monarez was dismissed from her role as CDC Director by the White House. Her termination came less than a month after her confirmation by the Senate and was reportedly triggered by her refusal to implement directives that she and her attorneys described as “unscientific” and “reckless.” Several senior CDC officials resigned following Dr. Monarez’s termination, including Chief Medical Officer Debra Houry, Immunization Director Demetre Daskalakis, Infectious Diseases Director Daniel Jernigan, and Public Health Data Director Jen Layden. Their departures cited concerns over the politicization of public health and vaccine policy under Secretary Kennedy.