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Federal 340B Ruling Underscores Need for Balanced Pharmacy Program

Last month, a federal appeals court in Philadelphia sided largely with pharmaceutical companies in the ongoing showdown involving access to 340B discount pricing via contract pharmacies.

The three-judge panel for the U.S. Court of Appeals for the Third Circuit decided that three drug companies – AstraZeneca, Novo Nordisk, and Sanofi – did not violate federal law when they imposed restrictions, conditions, and other limitations on 340B discount pricing on drugs dispensed at community and specialty pharmacies. “Congress never said drug makers must deliver discounted Section 340B drugs to an unlimited number of contract pharmacies,” the ruling noted.  Furthermore, the court ruled unanimously to strike down enforcement actions taken by the Department of Health and Human Services (HHS) to restore these discounts, saying the enforcement actions “overstepped the statute’s bounds.”

What does the ruling mean for 340B?

The ruling by the Third Circuit U.S. Court of Appeals is certainly a blow to Covered Entities seeking unfettered access to 340B discounts. The decision could embolden drug companies covered by the court’s jurisdiction to make their existing 340B conditions even more restrictive. It could also inspire new drug companies to implement contract pharmacy limitations, adding to the 21 manufacturers already restricting access to 340B discount pricing in some capacity. Read more >

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