Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.

Original title: “Makary, Prasad Under Fire as FDA Turmoil Reaches President Trump”

This Week's Dose Senate HELP Committee Chair Cassidy releases report on FDA reform. The report reflects Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Cassidy’s (R-LA) priorities for the modernization of the US Food and Drug Administration (FDA). The weekly check up on health and insurance law news from the past week, and predictions for next week: FDA reform report, HHS Medicaid data, HHS personnel changes Development of cutting-edge and rare disease therapies. In light of a rise in clinical holds and time-intensive requirements within the accelerated approval pathway, as well as limited drug approval frameworks for personalized medicines, Chair Cassidy recommended more judiciously using clinical holds, codifying recent agency actions related to therapies intended for small populations, and better coordinating reviews across FDA’s divisions and offices. Jim O’Neill is leaving HHS and will serve as the director of the National Science Foundation. He was previously acting director of the Centers for Disease Control and Prevention (CDC) and deputy secretary of HHS. Manufacturers will officially remove certain black box warnings on these treatments prescribed to address menopause symptoms. Warnings referencing risks of cardiovascular disease, breast cancer, and probable dementia will be removed, while warnings for endometrial cancer for systemic estrogen-alone products will remain. GAO releases report on No Surprises Act.

Original title: “This Week in Health and Insurance Legislation and Regulation”

Maintaining America's momentum demands that policymakers resist policies that undermine research and development incentives.

Original title: “Policymakers Must Sustain American Life Sciences Leadership”

The vacancy notice for the next EMA Executive Director has been published in the Official Journal of the European Union, marking the beginning of the recruitment process for the…

Original title: “Recruitment procedure opens for next Executive Director of the European Medicines Agency”

The Advisory Committee on Immunization Practices was supposed to convene next week, but that meeting has been pushed back as the CDC is once again leaderless and FDA’s double-reversal on Moderna’s flu shot highlights continued uncertainty in the vaccine space.

Original title: “ACIP Meeting Delayed as Turbulence Rocks CDC, US Vaccine Policy”

Tracy Beth Høeg addressed FDA staffers for the first time in her role as the fifth CDER chief under President Donald Trump, announcing inquiries into the use of SSRIs in pregnancy and RSV antibodies in infants despite well-documented safety of these treatments.

Original title: “FDA’s Top Drug Regulator To Probe Safety of Antidepressants, RSV Antibodies”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 7391: Community Health Center Drug Pricing Protection Act”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 7394: Mental Health Career Promotion Act”

Read twice and referred to the Committee on Finance.

Original title: “S 3751: Prescription Drug Supply Chain Pricing Transparency Act”

Referred to the House Committee on Ways and Means.

Original title: “HR 7409: Defend Rural Health Act of 2026”

Read twice and referred to the Committee on Finance.

Original title: “S 3750: REAL Health Providers Act”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 7289: Community Health Workforce Development Act”

Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Original title: “HR 2013: Medicare Home Health Accessibility Act”

Information on RSV vaccines to protect adults ages 50 and older against severe RSV illness.

Original title: “Vaccines for Adults”

Information about RSV for adults.

Original title: “RSV in Adults”

Quick and easy tips on how to increase dietary fiber, calcium, vitamin D, and potassium.

Original title: “Healthy Eating Tips”

The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a draft guidance for industry entitled "Questions and Answers About Requirements for Additional Traceability Records for Certain Foods." The draft guidance answers questions about the final rule entitled "Requirements for Additional Traceability Records for Certain Foods," which established additional recordkeeping requirements for persons who manufacture, process, pack, or hold foods the Agency has desig

Original title: “Questions and Answers About Requirements for Additional Traceability Records for Certain Foods; Draft Guidance for Industry; Availability”

The Department of Health and Human Services, National Institutes of Health published a Notice in the Federal Register on August 5, 2025. That notice requires a correction in the SUPPLEMENTARY INFORMATION section.

Original title: “Prospective Grant of an Exclusive Patent License: In Vivo Manufactured Anti-CD19 Chimeric Antigen Receptor (CAR) Products for the Treatment or Prevention of B Cell Mediated Autoimmune Diseases”

The National Cancer Institute (NCI), an institute/center of the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is giving notice of the license opportunity for the invention listed below, which is owned by an agency of the U.S. Government and is available to achieve expeditious commercialization of results of federally-funded research and development.

Original title: “Government Owned Inventions Available for License: Novel Human Immunogenic Epitopes of the Human Endogenous Retrovirus ERVMER34-1”

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 11 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

Original title: “Masuu Global Solutions LLC, U.S. Agent for Extrovis AG, et al.; Withdrawal of Approval of 11 Abbreviated New Drug Applications”