Since its enactment in 2018, the Eliminating Kickbacks in Recovery Act (EKRA) has remained one of the greater compliance mysteries facing the healthcare industry. The statute’s odd language and structure raises more...more
10/27/2025
/ Anti-Kickback Statute ,
Appeals ,
Appellate Courts ,
Compliance ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
Healthcare Facilities ,
Healthcare Fraud ,
Popular ,
Statutory Interpretation
The US Food and Drug Administration (FDA) recently issued warning letters to more than 40 compounding pharmacies, demanding that they cease certain advertising practices for a variety of compounded drug products, including...more
This issue of McDermott Will & Schulte’s Healthcare Regulatory Check-Up highlights regulatory activity for August 2025, including the formation of a joint Healthcare Advisory Committee between the US Department of Health and...more
10/6/2025
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Executive Orders ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Gender Dysphoria ,
Healthcare Fraud ,
OIG ,
Pharmaceutical Industry ,
Transgender
In a marked departure from long-standing practice, the US Food and Drug Administration (FDA) has begun publishing stand-alone complete response letters (CRLs), formal communications that detail the deficiencies in a drug...more
On May 7, 2025, the US District Court for the Northern District of Texas upheld the US Food and Drug Administration’s (FDA’s) decision to remove two tirzepatide injection medications from the FDA’s drug shortage list. This...more
6/13/2025
/ Appeals ,
Drug Compounding ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Reform ,
Judicial Authority ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements ,
Supply Shortages
On April 10, 2025, the US Food and Drug Administration (FDA) announced its intent to phase out the use of animal testing in the development of certain drugs and biologics. To help bring this “paradigm shift in drug...more
The Trump administration’s approach to cannabis reform will significantly impact the industry. As the proposed rulemaking to reschedule cannabis unfolds and nominees to critical agencies are confirmed, it is crucial for...more
In January 2025, various US Food and Drug Administration (FDA) centers and offices published their guidance agendas for the 2025 calendar year (CY). These agendas provide valuable insights into FDA’s regulatory priorities,...more
On December 19, 2024, the US Food and Drug Administration (FDA) issued a new final rule titled “Food Labeling: Nutrient Content Claims; Definition of Term ‘Healthy.’” The rule revises regulations that govern when food...more
On October 10, 2024, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced its agenda of proposed guidance documents to be published or developed in the 2025 fiscal year (FY)....more