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Earlier this year, the Health Resources & Services Administration took a strong stance against drug giant Johnson & Johnson’s plan for a proposed 340B rebate model, but the fight over rebates is far from over. 340B Health President and CEO Maureen Testoni joins us to discuss how the company is taking the issue to federal court and how they are not the only drugmaker doing so.

J&J Sues HRSA Over Rebates

J&J is arguing in court that HRSA lacks the authority to block a 340B rebate model. Such a model would allow individual drug companies effectively to impose their own rules on 340B drug purchases. These rules would curtail the number of drugs a company would offer a 340B discount on and reduce the number of patients that would be deemed 340B-eligible.

Other Drugmakers Pushing Rebates

Bristol Myers Squibb and Eli Lilly also sued HRSA, claiming the agency does not have the authority to stop a rebate model. Sanofi has not yet filed suit but is saying it will impose its rebate scheme in early January. The Sanofi model raises significant concerns not just because of the imminent effective date but because it would impose far more stringent restrictions on 340B eligibility than HRSA ever has.

State Contract Pharmacy Laws Rack Up More Wins

In another 340B issue before the federal courts, state contract pharmacy protections continue obtaining key litigation wins. Several district courts and one appeals court have upheld state laws designed to protect covered entity access to 340B pricing through community and specialty contract pharmacies.

Resources:

1. Brief Your Leadership on Drugmaker Rebate Schemes
2. The Wall Street Journal: “The Economic Imperative of Protecting 340B”
3. Register for the 340B Coalition Winter Conference