HRSA has ordered Akorn Inc. and BioComp Pharma to repay 340B covered entities for overcharges following audits.

HRSA Orders Two Drug Makers to Repay 340B Entities After Audits Show Overcharges

The U.S. Health Resources Services Administration (HRSA) has ordered two drug manufacturers that it audited—Akorn Inc. and BioComp Pharma—to repay 340B covered entities for overcharges.

HRSA updated its fiscal year 2021 audit results on its website last week. In April it reported that following an FY 2021 audit it ordered Chain Drug Marketing Association (CDMA) to repay 340B covered entities for overcharges.

Akorn makes branded and generic drugs. HRSA said its audit found that Akorn did not determine the difference between new drug price estimates and actual 340B ceiling price and offer a refund. The audit also found that Akorn did not submit quarterly pricing data to HRSA. HRSA did not say over how much time these violations occurred.

The agency said Akorn’s corrective action plan is pending approval. In 2018, Akorn notified covered entities that it did not offer 340B pricing on methylene blue 1% 10mL from July 1, 2017, through June 31, 2018, and was providing refunds for overcharges.

BioComp Pharma, a subsidiary of San Antonio, Texas-based Mission Pharmacal, makes generic drugs. HRSA said it found that BioComp did not offer covered outpatient drugs to eligible covered entities at the statutory ceiling price. It did not say for how much time. The company’s corrective action plan is pending approval.

HRSA currently audits five drug manufacturers each fiscal year. At least three of the five audited in FY 2021—CDMA, Akorn, and BioComp—had adverse findings and were ordered to make repayments for overcharges. HRSA said its FY 2021 audit of brand-drug manufacturer Neos Therapeutics (bought earlier this year by Aytu BioPharma) has no adverse findings. HRSA has not yet disclosed the identity of the fifth manufacturer it audited for 340B compliance during the fiscal year that ended Sept. 30.

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