Federal Court Vacates 340B Rule Regarding Orphan Drugs


On May 23, 2014, the U.S. District Court for the District of Columbia issued a Memorandum Opinion in Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human Services, et al.  At issue in the case was a regulation related to the purchase of orphan drugs by certain hospital entities participating in the 340B Federal Drug Pricing Program.  The court vacated the regulation and held that the federal government did not have the requisite authority to implement such a rule.


Topics:  340B, Affordable Care Act, Covered Entities, HHS, Hospitals, Orphan Drugs, Pharmaceutical

Published In: Administrative Agency Updates, Civil Procedure Updates, Health Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© McDermott Will & Emery | Attorney Advertising

Don't miss a thing! Build a custom news brief:

Read fresh new writing on compliance, cybersecurity, Dodd-Frank, whistleblowers, social media, hiring & firing, patent reform, the NLRB, Obamacare, the SEC…

…or whatever matters the most to you. Follow authors, firms, and topics on JD Supra.

Create your news brief now - it's free and easy »