On June 24, HRSA announced that it had issued new grant award terms to its HRSA-funded health centers to provide insulin and injectable epinephrine at or below the 340B price paid by the health center for the drugs. HRSA...more
6/27/2025
/ Drug Pricing ,
Executive Orders ,
Federal Funding ,
Government Agencies ,
Grants ,
Healthcare Facilities ,
Healthcare Reform ,
HRSA ,
Prescription Drugs ,
Regulatory Requirements ,
Reporting Requirements ,
Section 340B ,
Trump Administration
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