Rachel Turow on Department of Health and Human Services (HHS)

Trump Attempts To Rein In Drug Prices With Most-Favored-Nation Approach

On May 12, 2025, President Donald Trump signed the executive order (EO) “Delivering Most-Favored-Nation Prescription Drug Pricing To American Patients.” The EO sets forth policy positions that attempt to further rein in drug...more

5/14/2025 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Executive Orders , Healthcare , Healthcare Reform , Inflation Reduction Act (IRA) , Legislative Agendas , Medicare , New Legislation , Pharmaceutical Industry , Prescription Drugs , Regulatory Agenda , Trump Administration

Mass Layoffs at FDA Could Have the Greatest Impact on Products in Development - The Trump Administration’s First 100 Days

Companies that interact with FDA are likely to find that the layoff of 3,500 employees on April 1, 2025, affects their dealings in a variety of ways....more

5/1/2025 / Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Government Agencies , Layoffs , Medical Devices , Pharmaceutical Industry , Prescription Drugs , Regulatory Reform , Regulatory Requirements , Trump Administration

FDA at the Start of the Trump Administration: A Cheat Sheet

There has been a flurry of activity at the Food and Drug Administration (FDA) since the start of the Trump administration. Day-to-day operations at FDA are already significantly altered, and we expect the trickle-down effects...more

4/10/2025 / Department of Health and Human Services (HHS) , Executive Orders , Food and Drug Administration (FDA) , Food Safety , Medical Devices , Prescription Drugs , Regulatory Agenda , Regulatory Reform , Regulatory Requirements , Trump Administration

Makary Is Confirmed as Commissioner of an FDA in Transition

Dr. Martin Makary has been confirmed by the Senate as the next commissioner of the Food and Drug Administration (FDA). Dr. Makary is taking the helm at FDA during an unprecedented time for the agency, which has been subject...more

3/27/2025 / Department of Government Efficiency (DOGE) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Healthcare , Healthcare Reform , Pharmaceutical Industry , Prescription Drugs , Presidential Appointments , Public Health , Regulatory Agenda , Regulatory Reform , Trump Administration

Closing the GRAS Loophole: Secretary Kennedy’s Plan To Enhance FDA Food Safety Regulations

On March 10, 2025, Health Secretary Robert F. Kennedy Jr. initiated a significant shift in the regulation of ultra-processed foods by directing the Food and Drug Administration (FDA) to revise the GRAS (Generally Recognized...more

3/13/2025 / Department of Health and Human Services (HHS) , Enforcement Actions , Executive Orders , Final Rules , Food and Drug Administration (FDA) , Food Safety , GRAS , Healthcare , Healthcare Reform , Life Sciences , Policy Updates , Regulatory Reform , Regulatory Requirements , Rulemaking Process , State and Local Government

Make America Healthy Again Commission Aims To Combat Chronic Disease and Reform Health Policies

On February 13, 2025, at the swearing-in of Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr., President Donald Trump signed Executive Order “Establishing the President’s Make America Healthy Again...more

2/17/2025 / Centers for Disease Control and Prevention (CDC) , Department of Health and Human Services (HHS) , Environmental Protection Agency (EPA) , Executive Orders , Food and Drug Administration (FDA) , Healthcare Reform , Prescription Drugs , Public Health , US Foods , Vaccinations

Under RFK Jr., US Health Policy and FDA Operations May See Major Shifts

Robert F. Kennedy Jr. (RFK Jr.) has been confirmed by the Senate as secretary of the Department of Health and Human Services (HHS). In this capacity, RFK Jr. will oversee 13 agencies that are critical to U.S. health policy,...more

2/13/2025 / Alternative Medicine , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Executive Orders , Federal Funding , Food and Drug Administration (FDA) , Food Labeling , Healthcare , Healthcare Reform , National Institute of Health (NIH) , Pharmaceutical Industry , Popular , Regulatory Agenda , Regulatory Reform , Research and Development , Trump Administration , Vaccinations

Gauging the Likelihood of Trump Administration FDA Reforms

Since the announcement that president-elect Donald Trump would nominate Robert F. Kennedy Jr. (RFK Jr.) as the secretary of the U.S. Department of Health and Human Services (HHS), media reports have featured opinions from...more

1/23/2025 / Department of Health and Human Services (HHS) , Drug Safety , Food and Drug Administration (FDA) , GRAS , Medical Devices , Pharmaceutical Industry , Public Health , Regulatory Reform , Regulatory Requirements , Trump Administration , User Fees

Drug Pricing and Health Care Fraud Remain Key Issues

Key Points - - It remains to be seen what priorities Robert F. Kennedy Jr. and Marty Makary might set if confirmed as HHS secretary and FDA commissioner, respectively. - The Trump administration will likely focus on drug...more

1/21/2025 / Affordable Care Act , Artificial Intelligence , Centers for Medicare & Medicaid Services (CMS) , Cybersecurity , Data Privacy , Department of Health and Human Services (HHS) , Department of Justice (DOJ) , Drug Pricing , Food and Drug Administration (FDA) , Healthcare , Healthcare Fraud , Healthcare Reform , Inflation Reduction Act (IRA) , Medical Devices , Pharmaceutical Industry , Regulatory Agenda , Regulatory Reform , Secretary of HHS , Trump Administration

Rachel Turow

Skadden, Arps, Slate, Meagher & Flom LLP

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