Purdue Pharma’s Avrio Health subsidiary is giving 340B covered entities refunds for overcharges on Betasept antiseptic surgical scrub for purchases spanning 16 years—from Q2 2005 through Q2 2021. That period covers more than half of the 340B program’s existence.
During a speech yesterday at the 340B Coalition summer conference, 340B Health President and CEO Maureen Testoni observed that the U.S. Health Resources and Services Administration (HRSA) already had posted 22 manufacturer notices of refunds for 340B overcharges this year, compared with 17 such notices during their entirety of 2021.
HRSA posted Purdue’s notice on the Office of Pharmacy Affairs website on July 29. The refunds are for six NDCs in sizes ranging from four ounces to a gallon. Purdue said the 340B price recalculation was due to revisions to Medicaid pricing data.
Purdue said it is working with Apexus, the 340B prime vendor, to process wholesaler credits for affected entities. Purdue’s notice has contact information for entities that believe they are owed a refund but are not contacted by Apexus.
Purdue’s notice also includes information about refunds for overcharges from Q3 2019 through Q4 2021 on six NDCs for its Adhansia XR stimulant manufactured by its Adlon Therapeutics subsidiary.
Purdue is widely known for its role in fueling the U.S. opioid epidemic. The privately held company and its owners have paid the federal and state governments billions of dollars to settle lawsuits related to its role, and the company in 2019 filed for Chapter 11 bankruptcy.
Purdue also posted a 340B refund notice in 2021, three in 2020, and one in 2019.
Strides Pharma Refunds
India-based generic-drug manufacturer Strides Pharma is offering some 340B covered entities refunds for overcharges on multiple NDCs for purchases between Q3 2020 and Q1 2022, according to a notice posted on HRSA’s website yesterday.
Strides said the refunds are due to “a restatement of government pricing values for multiple quarters.” It said it has identified all entities that may be owed a refund and is contacting those owed a refund greater than $50 by U.S. mail. It said it “is also committed to issuing a refund to any covered entity that was overcharged,” including those owed less than $50. The notice includes contact information and instructions for entities not contacted by Strides by U.S. mail.