Dompé Settlement Highlights DOJ's Continued Scrutiny of Pharmaceutical Manufacturer Donations to Patient Assistance Foundations

Background

On September 10, 2026, the Department of Justice (DOJ) announced that Dompé U.S. Inc. (Dompé) — the North American subsidiary of Dompé farmaceutici S.p.A., a global pharmaceutical company — agreed to pay $32 million, of which $29.1 million constitutes restitution, to resolve liability arising from its interactions with patient assistance foundations under the Anti-Kickback Statute (AKS) and the False Claims Act (FCA). These interactions related to Oxervate, which is the only FDA-approved drug for the treatment of neurotrophic keratitis (NK). The settlement covers conduct from October 2018 through December 2021, spanning Oxervate’s US launch in December 2018 and Dompé’s subsequent interactions with foundations that provided co-pay assistance to patients who were prescribed Oxervate.

Dompé voluntarily disclosed the arrangements and interactions with patient assistance foundations to DOJ after conducting an internal compliance review. The settlement states that the company’s self-disclosure was among the first voluntary disclosures made by a pharmaceutical company to the US Attorney’s Office for the District of Massachusetts pursuant to its May 6, 2019, Guidelines for Taking Disclosure, Cooperation and Remediation into Account in False Claims Act Matters.Justice Manual § 4-4.112, available at: https://www.justice.gov/jm/jm-4-4000-commercial-litigation#4-4.112. The government credited Dompé for its voluntary disclosure, cooperation, and remediation. These remediation measures included modified procedures concerning interactions and contributions to patient assistance foundations, removal of the commercial team members from foundation decision-making, implementation of objective, documented criteria for foundation budgeting, and enhanced procedures concerning interactions between key account managers and patient access managers, including regarding foundations and foundation approval status. Notably, the Office of the Inspector General for the Department of Health and Human Services (the HHS-OIG) declined to require a corporate integrity agreement in conjunction with the settlement.

The settlement includes specific admissions that provide insight into pharmaceutical manufacturer interactions with patient assistance foundations that the government considers problematic.Settlement Agreement between Dompé U.S. Inc. and U.S. Dep’t of Just. (Sept. 9, 2026), available at: https://www.justice.gov/opa/media/1460856/dl. The inclusion of detailed admissions in the settlement agreement is particularly notable as part of a civil-only resolution. Under the settlement, Dompé admitted, acknowledged, and accepted responsibility for the following facts:

• Pre-launch foundation engagement. Prior to Oxervate’s US launch in December 2018, Dompé employees expressed concerns about entering the market before making a payment to a patient assistance foundation. Subsequently, Dompé engaged in discussions with the National Organization for Rare Disorders (NORD) and made an initial contribution to an NK-specific fund, after which Oxervate launched in December 2018. Nearly a year later, the Patient Access Network Foundation (PANF) opened a separate NK-specific fund with an initial Dompé contribution.
• Mid-year budget increases and contribution practices. Between 2019 and 2021, Dompé approved mid-year increases to foundation budgets for both NORD and PANF (despite maintaining an annual budgeting process), held amounts in reserve to assess mid-year when foundations were running low on funding and allocate donations accordingly, and, in certain instances, contributed more than the amounts that had been held in reserve.
• Solicitation and use of foundation and hub data. During this same period, Dompé solicited patient assistance data directly from the foundations and from the specialty pharmacy providing hub services. This data was shared with members of the market access and commercial teams and individuals involved in the foundation budgeting process, despite warnings from Dompé’s compliance consultant about the risk of reverse-engineering data from foundation activity to inform contribution decisions. Additionally, on multiple occasions, key account managers responsible for drug sales solicited and received information about specific patients’ foundation coverage status, in violation of Dompé’s own compliance program guidance.

These admissions underscore the types of interactions between manufacturers and patient assistance foundations that the government continues to scrutinize through enforcement actions.

Broader Guidance and Enforcement Context

Over the years, the government has pursued an aggressive enforcement campaign targeting pharmaceutical manufacturers and patient assistance foundations alleged to have used charitable assistance programs as conduits for illegal kickbacks to Medicare beneficiaries in violation of the AKS and the FCA. Through this campaign, the government has reached multi-million dollar settlements with numerous pharmaceutical manufacturers as well as several patient assistance foundations.

As a result, pharmaceutical manufacturers and patient assistance foundations alike have sought comfort through the HHS-OIG advisory opinion process, seeking the agency’s assessment of whether particular patient assistance arrangements comply with the AKS and the Beneficiary Inducement Statute. Advisory opinions are highly program-specific and fact-dependent, and are binding only as to the requesting party. Even so, they provide insight into the factors that HHS-OIG considers in evaluating patient assistance and support programs.

Recently, the D.C. Circuit provided further support for the theories underlying these enforcement actions in its review of an unfavorable advisory opinion issued by HHS-OIG regarding a patient support program. The advisory opinion, which was requested by the company, evaluated a financial support program for fertility services. In Vertex Pharmaceuticals Inc. v. HHS, the court reviewed the advisory opinion and affirmed HHS-OIG’s AKS analysis, holding that the AKS prohibits more than just quid pro quo transactions that corrupt medical decision-making.Vertex Pharms. Inc. v. U.S. Dep’t of Health and Hum. Servs., No. 25-5133, 2026 WL 2617588 (D.C. Cir. Sept. 4, 2026). In reaching its conclusion, the D.C. Circuit stated that it need not determine the degree of influence required to constitute inducement under the AKS. HHS-OIG stated, and the D.C. Circuit agreed, that a patient support arrangement designed to remove a financial barrier so that eligible patients purchase a product is remuneration and can violate the AKS.Id. The court’s reasoning reinforces the government’s enforcement theories in the space and signals the potential for continued scrutiny of patient assistance and support programs that are commonplace in the industry.

Practical Implications for Pharmaceutical Manufacturers

The Dompé settlement, the broader enforcement environment, and available HHS-OIG guidance highlight several considerations for pharmaceutical manufacturers that are considering establishing or evaluating their patient assistance practices. The following compliance safeguards merit particular attention.

• Ensure donation structures are genuinely charitable and carefully structured. The Dompé settlement reinforces that appropriate compliance guardrails should be in place before making donations to patient assistance foundations.
• Preserve foundation independence from donor influence and limit interactions with foundations. Foundations must operate independently, with their own governance, eligibility criteria, and decision-making processes. The Dompé settlement highlights the risks that arise when manufacturers influence or appear to influence foundation operations, including fund-level decisions, or engage in regular communication with a foundation.
• Limit data sharing and maintain strict information barriers between commercial and patient access functions. The settlement highlights the risks of patient-specific or foundation utilization data flowing to sales or commercial teams. Manufacturers should assess whether their firewalls adequately prevent foundation data (including funding and patient approval status) from flowing to unapproved individuals, informing commercial decision-making or enabling individuals to correlate donations with support for a company’s products.
• Ground budgeting processes in objective criteria. Manufacturers should consider implementing budgeting processes that are based on documented, objective criteria established in advance and should consider limiting commercial involvement. Mid-year adjustments to foundation contribution budgets driven by monitoring fund levels, utilization data, or enrollment may create the impression that donation levels are being calibrated to patient utilization.

Key Takeaways

The Dompé settlement serves as a reminder of DOJ’s continued focus on pharmaceutical manufacturer interactions with patient assistance foundations. The detailed admissions in the settlement agreement provide examples of practices and data flows that the government considers problematic.

Pharmaceutical manufacturers should consider monitoring their patient assistance practices, specifically limiting data reporting and access to hub and foundation information, reassessing their foundation donation structures, and evaluating their budgeting processes in light of the settlement and the broader enforcement environment.

What’s Next?

Latham & Watkins is tracking developments in DOJ’s continued scrutiny of pharmaceutical manufacturers’ patient assistance programs and interactions with foundations. The firm is well positioned to help clients to understand and adapt to enforcement trends in this space.