FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Proposed Acthar Giveaway May Violate Anti-Kickback Statue, OIG Says

Nov. 28, 2018

Mallinckrodt’s proposed patient access program for its Acthar gel injection could open the door for fraud and abuse under the Anti-Kickback statute, the HHS Office of the Inspector General (OIG) warned in response to the drugmaker’s inquiries.

The UK-based drug manufacturer has offered to provide Acthar to hospitals at no charge to treat an unspecified form of epilepsy. Acthar is an injectable, often self-administered gel-form drug that has 19 FDA-approved indications, including rheumatoid arthritis, infantile spasm and multiple sclerosis relapse.

Under Mallinckrodt’s proposed arrangement — which doesn’t apply to the drug’s other approved indications — the free doses would be given exclusively to inpatients. But the OIG concluded that Mallinckrodt “could potentially generate prohibited remuneration under the anti-kickback statute.”

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