Federal Reports

Endo Health Solutions Inc. (EHSI) was ordered May 2, 2024, to pay $1.086 billion in criminal fines and an additional $450 million in criminal forfeiture—the second-largest set of criminal financial penalties ever levied against a pharmaceutical company—for violations of the federal Food, Drug and Cosmetic Act (FDCA), according to the U.S. Department of Justice.EHSI pleaded guilty April 18, 2024, to one misdemeanor count of introducing misbranded drugs into interstate commerce. In its plea, EHSI admitted that from April 2012 through May 2013, some of its sales representatives marketed Opana ER with INTAC (Opana ER) to prescribers by touting the drug’s purported abuse deterrence, tamper resistance, and/or crush resistance despite a lack of clinical data supporting those claims. In addition, approved labeling for Opana ER did not provide adequate information for healthcare providers to safely prescribe Opana ER for use as an opioid that is abuse deterrent. According to the plea agreement, EHSI was responsible for the misbranding of Opana ER by marketing the drug with a label that failed to include adequate directions for its claimed abuse deterrence, in violation of the FDCA. EHSI withdrew Opana ER from the market in 2017. The investigation, supported by our office, found that some Amtrak employees and dependents were prescribed the misbranded drug.

16th Quarterly Report to Congress

This Office of Inspector General (OIG) Comprehensive Healthcare Inspection Program report describes the results of a focused evaluation of the quality of care delivered in the inpatient and outpatient settings of the Harry S. Truman Memorial Veterans’ Hospital, which includes multiple outpatient clinics in Missouri. This evaluation focused on five key operational areas:• Leadership and organizational risks• Quality, safety, and value• Medical staff privileging• Environment of care• Mental health (suicide prevention initiatives)The OIG issued seven recommendations for improvement in three areas:1. Medical staff privileging• Ongoing Professional Practice Evaluationo Completiono Service-specific criteria• Professional practice evaluation data2. Environment of care• Mental health inpatient unit over-the-door alarm testing3. Mental health• Comprehensive Suicide Risk Evaluation completion• Suicide prevention outreach activities• Reporting suicide behaviors to the suicide prevention team

With the Artemis campaign, NASA intends to return humans to the Moon and build a sustainable lunar presence as a foundation for human exploration of Mars. Given the high stakes of the first crewed flight, the Agency is working to identify and mitigate any risks and challenges to ensure the safe return of the Artemis II crew and safeguard NASA’s significant investment in Artemis vehicles and systems.