Адвокатский офис Техаса добился почти 34 млн долларов штрафа от AstraZeneca за нарушения в сфере поддержки пациентов

Patient support services violation in Texas Monthly insights, guidance alerts and blogs from global life sciences law firms, compiled for you in one place. Patient support activities The Texas Attorney General’s office announced a nearly $34 million settlement with AstraZeneca Pharmaceuticals LP, resolving allegations that the company violated the Texas Health Care Program Fraud Prevention Act—the state equivalent of federal anti-kickback laws—through improper patient support services tied to 17 of its drugs. According to ArentFox Schiff partner Hillary M. Stemple and associate Grace Y. Song, this settlement reflects the growing broader enforcement of patient support services against expense-relief arrangements and related white coat marketing, which is primarily at the state-level. In August 2025, Texas sued Eli Lilly over similar allegations involving its GLP-1 medications. California secured a $24 million settlement from AbbVie in 2020 over comparable programs. According to the settlement, AstraZeneca engaged in three primary schemes: - Free nurse support services: The company allegedly provided prescribers with complimentary nursing support valued at approximately $60,000 annually, eliminating costs practices would otherwise incur for staffing. - Free reimbursement services: AstraZeneca reportedly offered benefits verification, prior authorization, and appeals support at no cost. Representatives allegedly misrepresented themselves as patients’ “appointed representatives” or claimed to be calling from providers’ offices. - White coat marketing: The company allegedly deployed nurses as “nurse educators” who recommended AstraZeneca drugs while posing as independent healthcare professionals, leveraging their positions of trust to influence prescribing decisions. The authors suggest the settlement serves as a warning to pharmaceutical manufacturers about patient support programs. They recommend limiting reimbursement activities to templates and general guidance, clearly distinguishing education from sales, and ensuring compensation transparency and scrutiny of peer-to-peer and access arrangements to avoid similar enforcement actions. False Claims Act Massachusetts-based biopharma ophthalmology company EyePoint Pharmaceuticals will pay $4.66 million to settle federal allegations that it illegally paid kickbacks to medical facilities to boost sales of its post-surgery eye medication. According to law firm Choate, the settlement “serves as an important reminder that product support services can draw unwanted government scrutiny …” and “highlights the need for careful oversight of market access strategies, sampling programs, and product support initiatives.” The settlement resolves claims that EyePoint violated the False Claims Act by offering improper financial incentives to Ambulatory Service Centers (ASCs) to purchase and dispense DEXYCU, an injectable drug used to treat inflammation following cataract surgery. At issue was that after launching DEXYCU commercially in 2019, EyePoint created an “Assurance Program” designed to encourage ASCs to use the medication. Under this program, the company would reimburse or compensate facilities when commercial health insurers, Medicare Advantage, or Medicaid either denied claims for DEXYCU or reimbursed the drug below the ASCs’ purchase cost. The program was terminated in March 2022, at which point the company had paid the ASCs approximately $500,000 in reimbursement, and issued numerous units of product for free, as well as discounts. As part of the settlement, EyePoint has entered into a five-year Corporate Integrity Agreement with the U.S. Department of Health and Human Services Office of Inspector General, which will monitor the company’s compliance practices. The company will also pay an additional $21,518.68 to certain participating states through separate agreements. The case originated from a whistleblower lawsuit filed under the qui tam provisions of the False Claims Act. The whistleblower will receive approximately $791,769 from the settlement. FDA peptide compounding In July 2026, the FDA’s Pharmacy Compounding Advisory Committee (PCAC) recommended six of seven unapproved peptides for inclusion on the 503A bulks list, directly contradicting FDA staff recommendations. This, according to Sheppard lawyers, represents a significant shift in federal peptide access policy with immediate compliance implications. A blog from partner Dominick DiSabatino and associate Audry Mercer, noted that the FDA scientific staff opposed all seven peptides, citing fundamental concerns about chemical identity and characterization. The agency emphasized that without clear definitions of what constitutes each peptide, meaningful quality standards cannot be established. Additional concerns included lack of human clinical data and potential safety risks, including cancer promotion and immune responses. Under Section 503A, the authors noted, the FDA cannot impose pharmacy practice requirements such as adverse event reporting, supplier restrictions, or surveillance inspections. Many proposed regulatory guardrails exceed the FDA’s statutory authority, creating potential compliance gaps. This would mark the first time legal access for these peptides under compounding frameworks, with no formulation restrictions—presenting unregulated safety risks. According to the lawyers, the FDA must conduct formal notice-and-comment rulemaking, likely extending into 2027-2028. Key uncertainties include: - Whether peptides receive interim Category 1 status pending rulemaking - How FDA addresses characterization deficiencies in final rules - Enforcement discretion policies during the interim period Another PCAC meeting is scheduled for February 2027 to evaluate additional peptides, suggesting that meeting is the beginning of a larger regulatory conversation, rather than a conclusion, according to the lawyers. For a deeper dive into the peptide discussion, read this article from our sister site BioProcessing International. Pharmaceutical Compliance Congress West (PCC West) Sep 17, 2026 TO Sep 18, 2026 |San Diego, CA Unite with top-tier industry leaders from established and emerging pharmaceutical manufacturers to address complex regulatory changes impacting daily operations: FDA updates on SIUU, DOJ Enforcement Priorities and Patient and HCP Interaction Guidelines.