Key Points -
- Who is impacted: Manufacturers of pharmaceutical, biotechnology, medical device and food products.
- What is changing: The agency is prioritizing user fee reauthorization, the MAHA initiative and a push for...more
5/23/2025
/ Biosimilars ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Healthcare ,
Healthcare Reform ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform ,
Regulatory Requirements ,
Supply Chain ,
Technology
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
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
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
On February 19, 2025, President Donald Trump issued the executive order “Ensuring Lawful Governance and Implementing the President’s ‘Department of Government Efficiency’ Deregulatory Initiative” (the 2025 EO). The 2025 EO,...more
2/25/2025
/ Administrative Procedure Act ,
Chevron Deference ,
Congressional Review Act ,
Constitutional Challenges ,
Department of Government Efficiency (DOGE) ,
Executive Orders ,
Litigation Strategies ,
Non-Delegation Doctrine ,
OIRA ,
OMB ,
Regulatory Agenda ,
Regulatory Reform ,
Trump Administration
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
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