HRSA warns Sanofi over 340B rebate proposal

 The Health Resources and Services Administration has issued a warning to Sanofi over its plan to implement a new credit model for sales of certain covered outpatient drugs, threatening to remove the pharmaceutical company from the 340B Drug Pricing Program if the proposal is not halted. 

In a letter sent to Sanofi CEO Paul Hudson on Dec. 12, HRSA expressed concerns that the company's plan to implement the credit model starting Jan. 6 would violate the 340B statute by requiring certain covered entities such as disproportionate share, critical access hospitals and rural referral centers – to purchase drugs at prices above the statutory ceiling. 

According to the letter, Sanofi's proposal would force covered entities to order drugs at Wholesaler Acquisition Cost and then seek a credit from Sanofi for the difference between WAC and the 340B price.

HRSA argues that this model — which Sanofi has announced without approval from the HHS secretary — would violate the legal requirement that manufacturers offer covered outpatient drugs at or below the ceiling price set by 340B. 

The agency requested that Sanofi cease the implementation of its credit model immediately and notify HRSA by Dec. 20 of its decision. 

https://www.beckershospitalreview.com/pharmacy/hrsa-warns-sanofi-over-340b-rebate-proposal.html