Jordan Brossi at Holland & Knight LLP

Holland & Knight Health Dose: July 8, 2025

With the reconciliation package signed into law, the U.S. House of Representatives is in recess and will return on July 14, 2025. In the interim, the U.S. Senate will focus on the appropriations bills for fiscal year (FY)...more

7/10/2025 / Affordable Care Act , Appointments Clause , Centers for Disease Control and Prevention (CDC) , Centers for Medicare & Medicaid Services (CMS) , Children's Health Insurance Program (CHIP) , Constitutional Challenges , Department of Health and Human Services (HHS) , Drug Pricing , Federal Funding , Food and Drug Administration (FDA) , Healthcare Reform , HRSA , Medicaid , Medicare , New Legislation , SCOTUS , Section 340B , Transgender , Trump Administration

Food and Chemical Update: FDA Unveils Data-Driven Assessment Tool to Rank Food Chemicals

The U.S. Food and Drug Administration (FDA) is overhauling its approach to post-market oversight of food chemicals, marked by the proposed rollout of a new Post-Market Assessment Prioritization Tool. The FDA first announced...more

7/1/2025 / Chemicals , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , GRAS , Proposed Rules , Public Health , REACH , Regulatory Oversight , Regulatory Reform , Risk Assessment , Rulemaking Process , Toxic Chemicals , Toxic Substances Control Act (TSCA)

Holland & Knight Health Dose: June 24, 2025

Staff from U.S. Senate committees held meetings with the Senate parliamentarian over the weekend of June 20-22, 2025, to complete the "Byrd bath," a process by which committee staff make their case to the Senate...more

6/25/2025 / Budget Reconciliation , Centers for Medicare & Medicaid Services (CMS) , Congressional Committees , Department of Government Efficiency (DOGE) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Health Insurance Portability and Accountability Act (HIPAA) , Healthcare Reform , Medicaid , Medicare , Proposed Legislation , Senate Committees

FDA Announces "National Priority Voucher" Program to Accelerate Reviews of New Drugs

The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) announced on June 17, 2025, the creation of a new initiative called the "Commissioner's National Priority Voucher" (CNPV)...more

6/23/2025 / Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs , Priority Review Vouchers , Vouchers

U.S. Pharmaceutical Manufacturing and Supply Chain: 2025 Risks, Opportunities for Stakeholders

The U.S. House of Representatives Committee on Energy and Commerce's Subcommittee on Health held a recent hearing titled "Made in America: Strengthening Domestic Manufacturing and the Health Care Supply Chain." The hearing...more

6/19/2025 / APIs , Congressional Committees , Congressional Investigations & Hearings , Drug Pricing , Food and Drug Administration (FDA) , Healthcare Reform , New Legislation , Pharmaceutical Industry , Prescription Drugs , Regulatory Reform , Risk Assessment , Supply Chain , Trump Administration

Holland & Knight Health Dose: June 17, 2025

The U.S. Senate is in session for three days this week while the U.S. House of Representatives is in recess all week. Both chambers will return for a week before breaking for the July 4 recess. Negotiations on the...more

6/18/2025 / Budget Reconciliation , Congressional Committees , Congressional Investigations & Hearings , Department of Health and Human Services (HHS) , Executive Orders , Food and Drug Administration (FDA) , Healthcare , Healthcare Reform , Medicaid , Medical Research , Medicare , MedPAC , National Institute of Health (NIH) , Proposed Legislation

Holland & Knight Health Dose: June 10, 2025

The U.S. Senate will likely release additional sections of the reconciliation package this week. It is unlikely the Senate Committee on Finance, which has jurisdiction over Medicaid, will hold a markup on its portion of the...more

6/11/2025 / Abortion , Biden Administration , Centers for Medicare & Medicaid Services (CMS) , Congressional Committees , Congressional Investigations & Hearings , Controlled Substances Act , DEA , Department of Health and Human Services (HHS) , EMTALA , Federal Budget , Food and Drug Administration (FDA) , Healthcare Reform , Medicaid , Medicare , National Institute of Health (NIH) , Proposed Legislation , Senate Committees , Trump Administration

Food and Chemical Regulatory Update: The Make Our Children Healthy Again Assessment

The Make America Healthy Again (MAHA) Commission, as established by President Donald Trump's Feb. 13, 2025, Executive Order (EO) 14212, released its inaugural report on May 22, 2025, titled "The MAHA Report: Making Our...more

5/27/2025 / Artificial Intelligence , Chemicals , Clinical Trials , Environmental Protection Agency (EPA) , Food and Drug Administration (FDA) , Food Manufacturers , Food Supply , Information Reports , Pesticides , Prescription Drugs , Public Health , Regulatory Reform , Toxic Chemicals , Trump Administration

FDA Initiates New Post-Market Review Framework for Food Chemicals

The U.S. Food and Drug Administration (FDA) has announced a new initiative to systematically review the safety of chemicals already in the nation's food supply....more

5/23/2025 / Chemicals , EU , Federal Food Drug and Cosmetic Act (FFDCA) , FIFRA , Food & Drug Regulations , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Proposed Rules , Proposition 65 , Public Comment , Regulatory Oversight , Regulatory Reform , Toxic Chemicals , Toxic Substances Control Act (TSCA)

Holland & Knight Health Dose: May 20, 2025

The budget reconciliation package is expected to be considered by the full U.S. House of Representatives as soon as May 22, 2025. The House Committee on Rules is scheduled to meet on May 21, 2025, at which time additional...more

HHS, FDA Issue Request for Information to Support Administration's Deregulatory Agenda

The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) issued a Request for Information (RFI) on May 13, 2025, titled "Ensuring Lawful Regulation and Unleashing Innovation to...more

5/15/2025 / Comment Period , Department of Health and Human Services (HHS) , Deregulation , Drug Pricing , Executive Orders , Food and Drug Administration (FDA) , Public Comment , Regulatory Agenda , Request For Information , Trump Administration

Holland & Knight Health Dose: May 13, 2025

U.S. House of Representatives committees are scheduled to begin markups on additional portions of the budget reconciliation package on May 13, 2025. Both the House Committee on Ways and Means and the House Committee on Energy...more

Holland & Knight Health Dose: May 6, 2025

Reconciliation markups in the U.S. House of Representatives Committee on Energy and Commerce, as well as the House Committee on Ways and Means, were expected to be held this week but have been postponed until next week at the...more

5/7/2025 / Budget Reconciliation , Centers for Disease Control and Prevention (CDC) , Centers for Medicare & Medicaid Services (CMS) , Congressional Committees , Department of Health and Human Services (HHS) , Department of Justice (DOJ) , Executive Orders , Government Agencies , Health Insurance , Healthcare Reform , Medicaid , Medicare Advantage , National Institute of Health (NIH) , OSTP , Proposed Legislation , Public Comment , Restructuring , Trump Administration

HHS Announces Actions to Phase Out Use of Food Additives

The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) on April 22, 2025, announced their intent to phase out the use of certain food additives, including petrochemical-based dyes,...more

4/28/2025 / Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , GRAS , Proposed Rules , Regulatory Oversight , Regulatory Reform , Trump Administration

Trump Administration Initiates Section 232 Investigation into Pharmaceuticals

The U.S. Department of Commerce announced that it has initiated a Trade Expansion Act of 1962 Section 232 investigation to determine whether imports of pharmaceutical products and ingredients pose a national security risk to...more

4/17/2025 / Comment Period , Countermeasures , Executive Orders , Government Investigations , Imports , National Security , Pharmaceutical Industry , Public Comment , Section 232 , Supply Chain , Tariffs , Trade Expansion Act of 1962 , Trade Policy , Trump Administration , U.S. Commerce Department , US Trade Policies

Holland & Knight Health Dose: April 8, 2025

Looking Ahead: House to Vote on Compromise Budget Resolution On the heels of the U.S. Senate's passage of a compromise budget resolution, the U.S. House of Representatives is expected to consider the budget resolution on the...more