In the short time since taking office on January 20, President Donald Trump has taken executive actions calling for sweeping changes affecting the health care sector. While new administrations always bring changes, the speed...more
The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...more
1/22/2025
/ Administrative Procedure Act ,
Consent Decrees ,
Constitutional Challenges ,
Corporate Integrity Agreement ,
Deferred Prosecution Agreements ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Safety ,
Life Sciences ,
Medical Devices ,
Opioid ,
OxyContin ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Purdue Pharma ,
Qui Tam ,
Regulatory Requirements ,
Stem cells ,
Transparency
On January 7, 2025, FDA published a final guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products - Questions and Answers...more
1/14/2025
/ Advertising ,
Compliance ,
Enforcement Actions ,
Final Rules ,
First Amendment ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Marketing ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements
On September 27, 2024, the U.S. Court of Appeals for the Ninth Circuit reversed the district court’s decision in U.S. v. California Stem Cell Treatment Center, Inc. (“California Stem Cell”), holding that a clinic’s stem cell...more
12/10/2024
/ Chevron Deference ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Clinics ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
PHSA ,
Regenerative Medicine ,
Regulatory Oversight ,
Statutory Interpretation
Ropes & Gray attorneys share their analysis of administrative and court litigation, regulatory developments, key developments affecting federal program payments to hospitals and health systems, and other reimbursement-related...more
11/5/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Fixed Price ,
Health Care Providers ,
Healthcare ,
Hospitals ,
HRSA ,
Inpatient Prospective Payment System (IPPS) ,
Loper Bright Enterprises v Raimondo ,
Medicaid Drug Rebate Program ,
Medicare ,
ONC ,
Pharmaceutical Industry ,
Physician Fee Schedule ,
Prescription Drugs ,
Public Health Emergency ,
Reimbursements ,
SEC v Jarkesy ,
Statutory Interpretation ,
Telehealth