Health Law Daily Wrap Up, ANTI-KICKBACK PROHIBITION—SETTLEMENT AGREEMENTS: Drompé to pay $32M after self-disclosing FCA kickback scheme, (Sep 15, 2026)

By Sherri M. Schroeder, J.D.

The Oxervate drug manufacturer and its Italian parent company admitted to contributing money to patient assistance foundations that paid patient co-pays for the neurotrophic keratitis drug.

Drompé U.S. Inc. has agreed to pay $32 million to settle claims that could be made against it under the False Claims Acts (FCA's) Anti-Kickback Statute (AKS). Drompé and its Italian parent company, Drompé farmaceutici, are the makers of Oxervate, and FDA-approved drug used to treat neurotrophic keratitis (NK), which is a rare degenerative eye disease. After an internal review, the companies voluntarily disclosed to the U.S. Attorney's Office for the District of Massachusetts that Drompé U.S. interacted with and contributed to certain patient assistance foundations that pay the co-pays of certain patients, including Medicare beneficiaries. This violated the AKS and caused false claims to be submitted to Medicate in violation of the FCA. Drompé U.S. received credit under Department of Justice (DOJ) guidelines for taking disclosure, cooperation, and remediation into account. (Settlement Agreement, Sept. 9, 2026).

Details. The AKS prohibits pharmaceutical companies from paying remuneration to induce Medicare beneficiaries to purchase, or their physicians to prescribe, drugs that are reimbursed by Medicare. Drompé U.S. admitted, acknowledged, and accepted responsibility for the facts recited in the Settlement Agreement. Oxervate is the only drug approved by the FDA to treat NK. Oxervate launched in the U.S. in December 2018. In October and November 2018, Drompé U.S. employees spoke with representatives of the National Organization for Rare Diseases (NORD), a patient assistance foundation, and made an agreement to contribute to an NK fund at NORD. Drompé U.S. employees did the same with the PAN Foundation (PANF), another patient assistance foundation, in October 2019. Drompé U.S. included funding amounts for these organizations in its annual budget process, and sometimes also made mid-year increases as necessary. Drompé U.S. also solicited patient assistance foundation data directly from the foundations and from the specialty pharmacy that provided hub services to Drompé U.S., which contravened Drompé U.S.'s compliance program guidance. Two senior Drompé U.S. employees then failed to preserve data on their devices concerning contributions to NORD and PANF after learning of an internal investigation. By 2022, Drompé U.S. implementing changes to its patient assistance foundation contribution practices, including ensuring the Drompé U.S. general manager could not be involved in foundation decision making or have access to foundation data and that budgeting for foundation contributions be based on objective, documented criteria.

Credit. Drompé U.S. received credit under DOJ guidelines for taking disclosure, cooperation, and remediation into account in FCA cases. This was because Drompé voluntarily disclosed its actions, performed and disclosed the results of a thorough internal investigation, and voluntarily produced "significant volumes" of documents, including evidence outside of the U.S. The companies also made witnesses available for interview, including those outside the U.S.; identified documents, current and former employees, and third parties to the U.S.'s investigation; implemented appropriate remedial measures; and admitted and acknowledged Drompé U.S.'s conduct. It also mattered that the disclosure of information was not under threat of discovery or investigation.

Settlement. Drompé U.S. agreed to pay $32,000,000, plus interest, to settle the government's potential claims against it. Of this amount, $29,090,909 was restitution. In exchange, the government agreed to release Drompé U.S. from any civil or monetary claims it had for the covered conduct under the FCA, Civil Monetary Penalties Law, Program Fraud Civil Remedies Act, and the common law theories of payment by mistake, unjust enrichment, and fraud.

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