340B Fight Escalates As Biden Administration Seeks Refunds From Manufacturers, Threatens Them With Fines
Lilly, AstraZeneca, Novartis, Sanofi, Novo Nordisk and United Therapeutics ordered by HRSA to resume discounts to 340B contract pharmacies and refund past 'overcharges.'
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Federal court vacates enforcement letter to Lilly from HRSA, but the decision was not completely favorable to pharma. It also offers the view that the law does not allow manufacturers to restrict 340B discounts to hospitals using multiple contract pharmacies.
US government moves ahead with enforcement action while several court decisions remain pending on the viability of its interpretation of the law governing the 340B outpatient drug discount program. Underscoring industry’s confidence in its opposing view, Merck & Co. recently joined the companies that are restricting discounts to contract pharmacies.
As stakeholders begin to mull the impact of the Arthrex opinion, HHS withdraws its advisory opinion concluding manufacturers are legally bound to provide 340B discounts to contract pharmacies, and Lilly takes aim at 340b contract pharmacy ‘replenishment’ model.