Sanofi has joined several other pharmaceutical manufacturers suing the federal government over its moves to block the companies' proposed changes to how they issue 340B drug discounts.
Sanofi sued the Health and Human Services Department and the Health Resources and Services Administration Monday, alleging the agencies do not have the authority to stop the company from implementing a rebate model for the 340B drug pricing program. Under the model slated to begin next month, Sanofi would charge hospitals full price for certain medications and administer discounts later, rather than at the time of purchase.
Related: These pharma lawsuits could transform 340B
The complaint filed in the U.S. District Court for the District of Columbia followed threats from HRSA to fine the drugmaker and kick it out of the Medicare and Medicaid programs if Sanofi followed through with its proposal, which the agency said would violate federal law. The 340B statute requires pharmaceutical companies that want to remain in government-sponsored reimbursement programs to offer outpatient drug discounts to hospitals, clinics and other providers that treat many low-income patients.
The suit seeks to protect Sanofi’s 340B proposed rebate model and prevent the federal government from limiting its Medicare and Medicaid reimbursement. HRSA said in a Dec. 13 letter to Sanofi that the company has until Dec. 20 to remove its proposal.
HRSA declined to comment. Sanofi did not respond to a request for comment.