Akorn Pharmaceuticals, a generic and brand drug manufacturer, is giving 340B covered entities refunds for overcharges on 24 NDCs from Jan. 1, 2019, through Dec. 31, 2021.
The U.S. Health Resources and Services Administration (HRSA) posted Akorn’s notice to entities on its website this week. A HRSA fiscal year 2021 audit found that Akorn “did not determine the difference between new drug price estimates and the actual 340B ceiling price and offer a refund.” HRSA also found that the company “did not submit quarterly pricing data to 340B OPAIS,” the 340B program database.
Akorn filed for Chapter 11 bankruptcy in May 2020 after Fresenius Kabi terminated a proposed merger in April 2018. According to the company’s bankruptcy filing, beginning in 2017, Akorn “began to experience a steep and sustained drop-off in financial performance.” Akorn said in the filing that in 2018 it withdrew an application to the FDA for approval to make a generic drug after finding “certain data integrity deficiencies at the company’s facilities and corporate offices.”
Akorn also received two warning letters from the U.S. Food and Drug Administration in 2019 about regulatory compliance at two of its plants, according to the bankruptcy filing.
In its notice to 340B covered entities this week, Akorn said it will work with Apexus, the 340B prime vendor, to “to facilitate the processing of credit for the overpayments that the covered entity was charged during the specified periods. If an active wholesaler account cannot be
identified within two weeks after the initial communication, then Apexus will work to issue a check to those entities.”
HRSA audited five manufacturers in FY 2021. Four had adverse findings and were required to make repayments, including Akorn. HRSA audited 200 covered entities during the same period. Thirty-seven were required to make repayments due to 340B program infractions. HRSA conducts both targeted and random audits of manufacturers and entities.
HRSA has not yet disclosed results of any manufacturer audits conducted this fiscal year. It has posted the results of seven covered entity audits. None had adverse findings.