Generic drug manufacturer Unichem Pharmaceuticals USA must repay 340B covered entities for overcharges found during a 340B program compliance audit, the U.S. Health Resources and Services Administration (HRSA) said yesterday.
HRSA has been auditing five drug manufacturers per year for 340B compliance since 2016. The number of drug company audit findings has increased over the years with four companies cited in fiscal year 2021, tying the record set in 2019. HRSA audits 200 covered entities each fiscal year for 340B program compliance. Of the 86 entity audit results for FY 2022 posted to date, 18 had adverse findings either requiring repayments to manufacturers or termination of ineligible sites or contract pharmacies.
HRSA posted the Unichem audit findings on its website on Aug. 29. It said Unichem, a wholly owned subsidiary of Indian drug manufacturer Unichem Laboratories, “did not determine the difference between new drug price estimates and actual 340B ceiling price and offer a refund.” HRSA said Unichem also had an incorrect record in 340B OPAIS, the 340B program database.
Unichem’s audit findings were the first FY 2022 manufacturer audit results released by HRSA. The fiscal year ends Sept. 30. Relative to prior years, this was late in the fiscal year for HRSA to release its first manufacturer audit results.
340B Report asked HRSA yesterday morning, before the agency later in the day released the Unichem audit results, when it expected to begin posting FY 2022 manufacturer audit findings.
“As outlined in the FY 2022 President’s Budget, HRSA expects to complete 5 manufacturer audits for FY 2022,” HRSA replied by email. “Manufacturer audits for FY 2022 are still in progress. All results will be posted on the 340B website once they are finalized.”