On August 1, 2025, the Health Resources and Services Administration (“HRSA”) issued a Notice announcing the launch of the 340B Rebate Model Pilot Program (“Pilot Program”), that would dramatically change the way in which...more
8/8/2025
/ Comment Period ,
Covered Entities ,
Drug Pricing ,
Healthcare ,
HRSA ,
Manufacturers ,
Medicare Part D ,
Pharmaceutical Industry ,
Public Health ,
Rebates ,
Section 340B
A federal judge in D.C. recently ruled in favor of the U.S. Health Resources and Services Administration (“HRSA”), an administrative agency under the U.S. Department of Health and Human Services (“HHS”), by finding that drug...more
Last month, the U.S. Food and Drug Administration (the “FDA”) announced in a Declaratory Order the resolution of the shortage of semaglutide injection products Wegovy and Ozempic (the “February Declaratory Order”). On March...more
3/21/2025
/ Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Regulatory Authority ,
Regulatory Requirements
California is poised to pass a ballot measure aimed at imposing 340B spending restrictions for certain healthcare entities participating in the 340B Program who have historically engaged in spending that is not directly...more