Late last month, the U.S. Health Resources and Services Administration (HRSA) said on its website that generic drug manufacturer Unichem Pharmaceuticals USA had to repay 340B covered entities for overcharges found during a 340B program compliance audit.
According to Unichem, the audit found it overcharged only two entities and the repayment to both totals just $110.20. “Unichem cooperated fully with the audit process and is refunding those two facilities,” the company said. It said its audit covered six months of 340B ceiling price calculations and 340B pricing offered to over 11,100 eligible facilities.
Unichem, a wholly owned subsidiary of Indian drug manufacturer Unichem Laboratories, reached out to 340B Report in response to our Aug. 30 article about the audit result, to provide missing context it said.
When HRSA posts 340B manufacturer or covered entity adverse audits results, it gives no information about the scale of the infractions or the amounts of any repayments its requires.
In Unichem’s case, HRSA said on its website only that the manufacturer “did not determine the difference between new drug price estimates and actual 340B ceiling price and offer a refund” and that it had an “incorrect 340B OPAIS record.” It said the sanction was “repayment to covered entities.”
HRSA yesterday declined to comment on Unichem’s statements about its audit results.