Pharmaceutical manufacturer Sanofi on Dec. 16 notified the Health Resources and Services Administration (HRSA) that it is complying with the agency’s demands to suspend unilateral implementation of its proposed 340B Drug Pricing Program rebate model and pursuing legal action to authorize implementation.
Following advocacy by America’s Essential Hospitals — urging HRSA to take immediate action against illegal schemes to undermine the 340B program — HRSA gave Sanofi a Dec. 20 deadline to cease implementing its model or face the termination of its pharmaceutical pricing agreement (PPA). A PPA is necessary for Medicaid and Medicare Part B coverage.
Simultaneous to its notice, Sanofi also filed a lawsuit in federal court requesting injunctive relief to authorize immediately rebate model implementation. Sanofi argues the proposed model is explicitly authorized by statute, and the courts should allow immediate implementation. Sanofi would require disproportionate share hospitals, critical access hospitals, sole community hospitals, rural referral centers, and consolidated health centers purchase 25 of its products at list price. Sanofi also intended to implement later a further test of patient 340B eligibility, based on its own interpretation of HRSA’s patient definition and added criteria.
Sanofi now joins manufacturers Johnson & Johnson, Eli Lilly, and Bristol-Myers Squibb in separate suits to demand the courts authorize their proposed rebate models.
In a statement, America’s Essential Hospitals applauded HRSA’s action and called on Sanofi and other drug manufacturers to end their illegal actions that compromise access to care.
Contact Director of Policy Rob Nelb, MPH, at rnelb@essentialhospitals.org or 202.585.0127 with questions.
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