BOSTON – Akorn Operating Company LLC (Akorn), an Illinois-based pharmaceutical company, has agreed to pay $7.9 million to resolve allegations that it caused Medicare to pay false claims. Specifically, Akorn caused Medicare Part D to pay for three Akorn generic drugs that were no longer eligible for Medicare coverage. As part of the settlement, Akorn admits that it continued to sell generic drugs under obsolete prescription-only labeling.
FDA-approved “prescription only” (Rx-only) drugs may be dispensed only pursuant to a prescription. Medicare Part D reimburses for Rx-only drugs, but it does not reimburse for “over the counter” (OTC) drugs, which may be purchased by retail customers without a prescription. Subject to FDA approval, pharmaceutical manufacturers may seek to fullyconvert a brand-name Rx-only drug to an OTC drug. After FDA’s approval of a drug’s full conversion to OTC status, the drug is no longer considered an Rx-only product and makers of generic equivalents, like Akorn, are then required either to seek FDA approval for their own OTC switch or to seek withdrawal of their generic’s Rx-only approval and cease marketing it.
Akorn is a pharmaceutical manufacturer which sold, among other products, the following generic drugs: (1) Diclofenac Sodium 1%, a generic nonsteroidal anti-inflammatory cream (Diclofenac); (2) Olopatadine Hydrocholoride 0.1% and 0.2%, a generic antihistamine eyedrop (Olopatadine); and (3), Azelastine Hydrochloride 0.15%, a generic...
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