A federal judge has denied requests from Novartis, AbbVie and the Pharmaceutical Research and Manufacturers of America to block Washington state’s 340B law before it takes effect June 11.
Washington enacted the law March 25; it prohibits drug manufacturers from restricting delivery of 340B drugs to covered entities and contract pharmacies and bars manufacturers from requiring claims, utilization or purchasing data as a condition of providing 340B drugs unless federal law requires the information.
The statute also requires manufacturers to submit annual reports on their participation in the 340B program, including the number of units distributed, aggregate discounts and average discounts for the top 25 340B drugs dispensed in the state.
Novartis sued to block Washington’s law in March, and PhRMA has filed three lawsuits challenging the law. In a June 9 order, Judge David Estudillo of the U.S. District Court for the Western District of Washington ruled the plaintiffs had not shown a likelihood of success on the merits of their constitutional and preemption claims and denied their motions for preliminary injunction.
The court said Washington has a substantial interest in promoting 340B sales to covered entities so they can use discounts to sustain healthcare programs and services.
The drugmakers’ challenge comes as courts across the country have reached conflicting conclusions on state authority to regulate 340B program participation. A federal judge permanently blocked North Dakota’s 340B law in April, and the 4th Circuit Court of Appeals sided with drugmakers in a Maryland case. But courts in Hawaii and Colorado denied manufacturers’ bids to block similar state laws, the Supreme Court rejected a PhRMA challenge to Arkansas’ 340B statute, and the 5th Circuit upheld Mississippi’s contract pharmacy protections.
Becker’s is tracking the full litigation landscape as it develops.
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