On December 18, 2025, President Trump signed the FY 2026 National Defense Authorization Act (2026 NDAA) into law and enacted the BIOSECURE Act, which restricts the ability of U.S. Executive Agencies to contract with...more
12/26/2025
/ Biotechnology ,
Department of Defense (DOD) ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
Federal Funding ,
Government Agencies ,
Grandfathering Rules ,
Life Sciences ,
National Security ,
NDAA ,
Regulatory Requirements ,
Safe Harbors ,
Supply Chain ,
Technology Sector
On December 19, 2025, the Centers for Medicare & Medicaid Services (CMS) released GLOBE (Global Benchmark for Efficient Drug Pricing Model) and GUARD (Guarding U.S. Medicare Against Rising Drug Costs) Models—two drug pricing...more
On Sunday, December 7, 2025, Congress released the final draft compromise version of the FY 2026 National Defense Authorization Act (NDAA), and the package includes the BIOSECURE Act, reflecting weeks of additional...more
12/8/2025
/ BIOSECURE Act ,
Biotechnology ,
Department of Defense (DOD) ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
Federal Funding ,
Medicaid ,
National Security ,
NDAA ,
Proposed Legislation ,
Regulatory Requirements ,
Supply Chain
On October 31, 2025, the Centers for Medicare & Medicaid Services (CMS) released its Final Rule for the Calendar Year (CY) 2026 Physician Fee Schedule (PFS), detailing significant updates to Medicare Part B payment policies....more
11/7/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Final Rules ,
Inflation Reduction Act (IRA) ,
Medicaid Drug Rebate Program ,
Medicare ,
Medicare Part B ,
Pharmaceutical Industry ,
Physician Fee Schedule ,
Regulatory Requirements ,
Reporting Requirements
This alert reflects our preliminary analysis of BIOSECURE 2.0 (as we are calling it) immediately following the passage of both the House and Senate versions of the FY2026 NDAA. Given that this update is fast-moving, we will...more
10/10/2025
/ Biotechnology ,
China ,
Department of Defense (DOD) ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
Federal Funding ,
Foreign Entities ,
National Security ,
NDAA ,
New Legislation ,
Procurement Guidelines
Expected New Drug Pricing Model: We anticipate the Centers for Medicare & Medicaid Services (CMS) to release a significant proposed new drug pricing model through its Innovation Center called the Global Benchmark for...more
10/2/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Clinical Trials ,
Comment Period ,
Draft Guidance ,
Drug Pricing ,
EU ,
Final Rules ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Life Sciences ,
Medical Devices ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Reform ,
Section 340B
FDA is now accepting submissions to the Commissioner’s National Priority Voucher (CNPV) pilot program, and with only five vouchers to be awarded as part of the initial year of the program, the competition is anticipated to be...more
On July 31, 2025, the Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs (OPA) issued a 340B Drug Pricing Program notice (the “Notice”) announcing the launch of a voluntary 340B rebate model pilot...more
8/4/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Covered Entities ,
Drug Pricing ,
HRSA ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Pilot Programs ,
Public Comment ,
Rebates ,
Reporting Requirements ,
Section 340B
The Trump administration recently announced the renewal of a new cross-agency collaboration between the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) in the form of the DOJ-HHS False Claims...more
7/22/2025
/ Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Electronic Protected Health Information (ePHI) ,
Enforcement Actions ,
Enforcement Priorities ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Kickbacks ,
Medicare ,
Medicare Advantage ,
Trump Administration ,
Whistleblowers ,
Working Groups
As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more
7/9/2025
/ Abbreviated New Drug Application (ANDA) ,
Artificial Intelligence ,
Budget Reconciliation ,
Deregulation ,
Drug Pricing ,
EU ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Life Sciences ,
Medicaid ,
Medical Devices ,
Medical Technology Companies ,
Medicare ,
New Legislation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Reform ,
Regulatory Requirements ,
Tariffs ,
Trump Administration ,
UK
On May 6, 2025, with almost no discernible press or public announcements, the Dental Trade Alliance (DTA) – a trade association of dental suppliers and service providers – issued a revised and restated U.S. Code of Ethics...more
We previously reported on an uptick in the passage of state drug price transparency legislation. What follows is an update to that report. As of April 2025, approximately 23 states had passed drug price transparency laws....more
6/3/2025
/ Appeals ,
Drug Pricing ,
Enforcement ,
Enforcement Actions ,
Government Agencies ,
Manufacturers ,
New Legislation ,
Penalties ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements ,
Reporting Requirements ,
State and Local Government
Prescription Drug Affordability Boards (PDABs) are becoming a larger part of the state drug price regulatory landscape. The boards are regulatory bodies that review the affordability and cost of specific prescription drugs. ...more
In the past month, President Trump signed two executive orders concerning drug access and affordability, including for biologics and biosimilar drugs. On April 15, 2025, President Trump signed Executive Order No. 14273 (“EO...more
On May 12, 2025, President Trump signed the most recent Executive Order on drug pricing, Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients. ...more
5/13/2025
/ Department of Health and Human Services (HHS) ,
Drug Pricing ,
Enforcement Actions ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Medicaid ,
Medicare ,
Most-Favored Nations ,
Pharmaceutical Industry ,
Prescription Drugs ,
Trump Administration
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
4/1/2025
/ Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
Electronic Protected Health Information (ePHI) ,
Food and Drug Administration (FDA) ,
Government Shutdown ,
Life Sciences ,
Medical Devices ,
New Regulations ,
Pharmaceutical Industry ,
Proposed Rules ,
Regulatory Requirements ,
Tariffs ,
Trump Administration ,
US Trade Policies
For years, medtech firms around the globe (and certainly European companies) introduced their products in Europe, which requires obtaining a CE mark certifying compliance with relevant EU health and safety standards, prior to...more
3/11/2025
/ Certification Requirements ,
Data Protection ,
EU ,
Food and Drug Administration (FDA) ,
Health & Safety Standard ,
Intellectual Property Protection ,
Life Sciences ,
Medical Devices ,
Medical Technology Companies ,
Popular ,
Regulatory Requirements
In February 2025, the Office of Inspector General (OIG) for the US Department of Health and Human Services issued favorable advisory opinions Advisory Opinion 24-10 and Advisory Opinion 24-12, providing additional guidance on...more
Goodwin’s 2025 Rare Disease Symposium, held on February 5 in Boston and virtually, gathered patient advocates and caregivers, providers, researchers, biotech and medtech leaders, investors, and policy experts to discuss the...more
2/26/2025
/ Biotechnology ,
Food and Drug Administration (FDA) ,
Funding ,
Health Care Providers ,
Healthcare ,
Innovation ,
Life Sciences ,
Med Tech ,
Medical Research ,
Pharmaceutical Industry ,
Public Policy ,
Public Private Partnerships (P3s)
In a unanimous panel opinion filed on February 18, 2025, the First Circuit held that False Claims Act cases predicated on violations of the Anti-Kickback Statute (“AKS”), require proof that alleged kickbacks were the...more
2/21/2025
/ Anti-Kickback Statute ,
Appeals ,
But For Causation ,
Causation ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Judicial Authority ,
Litigation Strategies ,
Medicare ,
Pharmaceutical Industry ,
Regeneron ,
Statutory Interpretation
Based on recent policy signals and statements from incoming administration officials, a picture of potential regulatory and policy changes that could affect biotech, pharmaceutical, and medical device companies in coming...more
1/22/2025
/ Antitrust Provisions ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Public Policy ,
Regulatory Agenda ,
Trump Administration
As Washington prepares for new leadership in January 2025, significant policy changes appear on the horizon. The incoming administration’s agenda suggests a substantial shift in US economic and regulatory priorities, with...more
1/7/2025
/ Artificial Intelligence ,
Blockchain ,
Corporate Governance ,
Corporate Taxes ,
Cybersecurity ,
Department of Labor (DOL) ,
Digital Assets ,
Environmental Social & Governance (ESG) ,
Equal Employment Opportunity Commission (EEOC) ,
Federal Contractors ,
Federal Labor Laws ,
Healthcare ,
Legislative Agendas ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
NLRB ,
Privacy Laws ,
Public Procurement Policies ,
Regulatory Agenda ,
Tax Cuts and Jobs Act ,
Trade Relations ,
Trump Administration ,
US Trade Policies
On October 4, 2024, a US House version of the revised Promising Pathway Act (PPA) 2.0 was introduced, sponsored by Rep. Bruce Westerman (R-AR). ...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more
10/1/2024
/ Biden Administration ,
Biologics ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Diversity ,
Draft Guidance ,
EU ,
European Medicines Agency (EMA) ,
Executive Orders ,
Final Rules ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Information Reports ,
Laboratory Developed Tests ,
Life Sciences ,
Med Tech ,
Medical Research ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
New Guidance ,
OCR ,
Pediatrics ,
Pending Legislation ,
Personal Data ,
Pharmaceutical Industry ,
Scientific Research ,
UK
The BIOSECURE Act passed the House of Representatives on September 9, 2024, with a bipartisan vote of 306–81. It has now moved to the Senate, which has its own version of the BIOSECURE Act already in play. If passed by the...more