The Centers for Medicare & Medicaid Services (CMS) released the calendar year 2026 Physician Fee Schedule (PFS) proposed rule, which was published in the Federal Register on July 16, 2025. The comment period ends on September...more
7/29/2025
/ Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Drug Pricing ,
Federal Register ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Life Sciences ,
Medicare ,
Medicare Part D ,
Outpatient Prospective Payment System (OPPS) ,
Pending Litigation ,
Pharmaceutical Industry ,
Pharmacies ,
Physician Fee Schedule ,
Prescription Drugs ,
Proposed Rules ,
Section 340B ,
Vouchers
On July 4, 2025, President Trump signed into law the One Big Beautiful Bill Act, his signature policy legislation. Two aspects of this legislation are particularly relevant for drug pricing....more
7/15/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
HRSA ,
Inflation Reduction Act (IRA) ,
Medicare ,
Orphan Drugs ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B ,
Trump Administration
On June 12, 2025, Senators Bernie Sanders (I-Vt.) and Angus King (I-Maine) introduced the End Prescription Drug Ads Now Act, with Senators Chris Murphy (D-Conn.), Peter Welch (D-Vt.), Jeff Merkley (D-Ore.), and Dick Durbin...more
7/9/2025
/ Advertising ,
Constitutional Challenges ,
Department of Health and Human Services (HHS) ,
Direct to Consumer Sales ,
FDCPA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Reform
The executive order shifts policy on enforcement of criminal regulatory offenses, steering away from criminal enforcement of strict liability offenses in regulatory matters....more
6/10/2025
/ Controlled Substances Act ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Guidance ,
Executive Orders ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Non-Enforcement ,
Regulatory Requirements ,
Strict Liability ,
Trump Administration
Recent developments include leadership changes, workforce reductions, and policy shifts at HHS and FDA, reshaping agency operations under President Trump’s administration....more
5/16/2025
/ Department of Health and Human Services (HHS) ,
Deregulation ,
Enforcement Priorities ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Life Sciences ,
Reduction of Force ,
Regulatory Agenda ,
Reorganizations ,
Rulemaking Process ,
Trump Administration
The final guidance describes FDA’s enforcement discretion policy for sharing scientific information on unapproved uses of approved products and suggests a safe harbor for sharing off-label information consistent with the...more
1/16/2025
/ Compliance ,
Data-Sharing ,
Enforcement ,
Final Guidance ,
Final Rules ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Off-Label Use ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Authority ,
Regulatory Requirements ,
Risk Management ,
Safe Harbors