On Wednesday, October 14, 2015, the U.S. District Court for the District of Columbia (the "Court"), Judge Rudolph Contreras, vacated the Health Resources and Services Administration's ("HRSA") interpretive rule on Orphan Drugs ("the Interpretative Rule") as "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law."[1] As a result of the ruling, pharmaceutical manufacturers are not required to provide 340B discounts to certain types of covered entities for Orphan Drugs, even when the drugs are prescribed for uses other than to treat the rare ...
Blog Editors
Recent Updates
- FDA Warns Against “Over-Reliance” on AI Pharmaceutical Manufacturing . . . But How Much Reliance Is Too Much?
- Five Federal Cases Health Care and Life Sciences GCs Should Continue to Watch in 2026
- CMS Announces Nationwide Moratoria on New Medicare Enrollment for Hospices, Home Health Agencies
- Medicaid Behavioral Health Investigations and Payment Suspensions in D.C. Are Increasing – How Providers Can Limit Risk
- ‘Emilie’ Is Not a Psychiatrist: Pennsylvania Board of Medicine Alleges Unlawful Practice of Medicine by an AI Chatbot