Not Business as Usual: The Ramifications of Orphan Drug Court Rulings in 2014 and a Look to 2015

Event Details


January 29, 2015

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The attorneys of Arnall Golden Gregory’s Food and Drug Practice invite you to attend a complimentary one-hour webinar, “Two Important Developments that Could Affect Orphan Drugs for 2015.”

The status of orphan drugs regarding pricing and market exclusivity remains in flux in 2015. A federal court vacated HHS’ Orphan Drug Rule after the trade group, Pharmaceutical Research & Manufacturers of America (PhRMA), filed suit. A few months later, the same federal court issued a decision that could affect FDA orphan drug determination. A decision is also pending in a suit filed by PhRMA challenging HHS’s interpretive rule regarding orphan drug exclusion under the 340B Drug Pricing Program. 

Register Now to hear AGG’s Food and Drug Practice leader, Alan Minsk, and partner, Neil Hoffman discuss these actions and how they might affect the orphan drug companies.

Credits: This webinar is approved for 1 hour of CLE credit by the State Bar of Georgia.