An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.

Original title: “HHS Backs Prasad Amid Moderna Flu Shot Blowback”

AbbVie contends that Botox should have been excluded from the IRA drug price negotiation program because it is a plasma-derived product.

Original title: “AbbVie Sues HHS, CMS for Including Botox in Drug Price Negotiation Program”

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Original title: “S 3853: A bill to amend the Public Health Service Act to end the liability shield for vaccine manufacturers, and for other purposes.”

Read twice and referred to the Committee on Veterans' Affairs.

Original title: “S 3837: A bill to designate the clinic of the Department of Veterans Affairs in Des Moines, Iowa, as the "Staff Sergeant Edgar Torres-Tovar VA Clinic" and to designate the community-based outpatient clinic of the Department in Marshalltown, Iowa, as the "Staff Sergeant William Nathaniel Howard VA Clinic".”

Read twice and referred to the Committee on the Judiciary.

Original title: “S 3346: A bill to establish a special registration under the Controlled Substances Act for schedule I eligible investigational drugs under the Federal Right to Try law.”

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Original title: “S 1847: A bill to amend the Employee Retirement Income Security Act of 1974 to clarify the treatment of certain association health plans as employers, and for other purposes.”

Placed on Senate Legislative Calendar under General Orders. Calendar No. 307.

Original title: “S 921: A bill to direct the Secretary of Health and Human Services to issue guidance on whether hospital emergency departments should implement fentanyl testing as a routine procedure for patients experiencing an overdose, and for other purposes.”

The Public Health Associate Program trains early-career public health professionals.

Original title: “About The Public Health Associate Program for Recent Graduates”

Discover the requirements and eligibility standards for PHAP host sites.

Original title: “Host Site Eligibility & Requirements”

Find out how to apply to host PHAP associates and learn about how PHAP benefits your host site.

Original title: “Applying to Host an Associate”

Learn when to apply, who to contact for questions, and the PHAP timeline for host site applications.

Original title: “Prepare & Submit Host Site Application”

The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jeremy Spencer Brown for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Brown was convicted of one felony count under Federal law for introduction of unapproved drugs into interstate commerce with intent to defraud or mislead. The factual basis supporting Mr. Brown's conv

Original title: “Jeremy Spencer Brown: Final Debarment Order”

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Original title: “S 1409: Public Safety Officer Concussion and Traumatic Brain Injury Health Act of 2025”

Several states have introduced novel and stringent legislation to regulate compounded medications (including those specific to weight loss)... What's new: Several states have introduced novel and stringent legislation to regulate compounded medications (including those specific to weight loss), which may directly conflict with the federal regulatory framework established by the Federal Food, Drug, and Cosmetic Act. Although the GLP-1 shortage that drove the rapid and ubiquitous rise of compounding has been resolved (see our December 2024 client alert on that), compounded drugs continue to be clinically necessary for certain patients. Branded drug manufacturers have vociferously fought against compounded versions of their products by pressuring FDA to take more regulatory and enforcement action, petitioning state boards of pharmacy and now pressing states to introduce legislation that would impose additional, stringent regulatory requirements on compounders. Purity percentages and quality testing: Some bills would mandate specific purity percentages or independent quality-control testing for APIs and compounded drugs. State-imposed purity standards risk conflicting with federal definitions and could result in products that are legal federally but illegal at the state level, or vice versa. Requirements for warnings and disclosures on labels: Some bills may require additional language on labels for compounded weight-loss medications, including listing all active and inactive ingredients, the quantity of those ingredients and the ingredients' country of origin. For example, if a state law prohibits the use of a bulk substance that is permitted by FDA, or allows a substance that FDA has excluded, the state law undermines the uniformity and authority of the federal law. State action in this area would create a patchwork of standards and frustrate the federal objective of nationwide consistency in drug safety and compounding practices.

Original title: “State Compounding Legislation: Federal Preemption, State Limits And Patient Impact - Food and Drugs Law - United States”

After receiving a letter directly from CBER Director Vinay Prasad, Moderna said the FDA had previously signed off on the use of a licensed flu vaccine as a comparator for a Phase 3 study of mRNA-1010.

Original title: “FDA Refuses To Review Moderna’s mRNA Flu Vaccine, Claims Trial Inadequacies”

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Original title: “S 1866: A bill to amend the Public Health Service Act to reauthorize and improve the National Breast and Cervical Cancer Early Detection Program for fiscal years 2026 through 2030, and for other purposes.”

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Original title: “S 1677: A bill to provide health insurance benefits for outpatient and inpatient items and services related to the diagnosis and treatment of a congenital anomaly or birth defect.”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 7465: To amend the Public Health Service Act to direct the Secretary of Health and Human Services to establish a demonstration program to award grants to States to improve the provision of recommended immunizations for children, adolescents, and adults through the use of mobile vaccination units, and for other purposes.”

Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, 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 7478: To amend title XVIII of the Social Security Act to establish certain standards and requirements with respect to financial assistance and medical debt collection for hospitals participating in the Medicare program, and to amend title III of the Public Health Service Act to establish a grant program for purposes of medical debt relief.”

Referred to the House Committee on Agriculture.

Original title: “HR 7474: To require the Secretary of Agriculture to establish and maintain a training program for Natural Resources Conservation Service personnel and third-party providers on the rapidly evolving methodologies, science, and practices of soil health management systems on agricultural land, and for other purposes.”