Search

This document discusses the potential implications of expanding access to the medication semaglutide for Medicare beneficiaries with elevated body mass index (BMI). The study found that approximately 1 in 7 beneficiaries with elevated BMI would be newly eligible for semaglutide, but the majority would remain ineligible if a narrow definition of established cardiovascular disease (CVD) is used. The document highlights the importance of weight control for patients with elevated BMI and suggests that the definition of established CVD used by Part D plans for coverage of semaglutide could have significant public health implications. However, the document also acknowledges that access to semaglutide may be impacted by factors such as out-of-pocket costs, formulary placement, drug shortages, and utilization management strategies. The potential budgetary impacts of expanding access to semaglutide are also discussed, with estimates suggesting that it could generate over $10 billion in new annual federal spending. The document concludes by emphasizing the need for near-term policy solutions to control these budgetary impacts. [Extracted from the article]

Context: The False Claims Act is the US federal government's primary tool for identifying and penalizing pharmaceutical fraud. The Department of Justice uses the False Claims Act to bring civil cases against drug manufacturers that allegedly obtain improper payment from federal programs. Methods: The authors searched the Department of Justice website for press releases published between 2006 and 2022 that announced fraud actions brought against drug companies. They then used the World Health Organization's Anatomical Therapeutic Classification index to identify the classes of prescription drugs implicated in fraud actions. Findings: During fiscal years 2006–2022, payments by six manufacturers amounted to more than 28% of total payments made as a result of federal False Claims Act actions. Nervous system and cardiovascular drugs were the classes of medications most commonly implicated in alleged fraud. Federal officials most frequently alleged that companies improperly promoted nervous system drugs and paid kickbacks to increase revenues from cardiovascular, antineoplastic and immunomodulating, and alimentary tract and metabolism drugs. Conclusions: Despite frequent pharmaceutical fraud settlements and penalties, incidence of alleged fraud among drug companies remains high. Alternative methods for preventing and deterring fraud could help safeguard our health systems and promote public health, and policy makers should ensure that effective fraud enforcement complements preventive public health regulation. [ABSTRACT FROM AUTHOR]

This study estimates public and private spending on genetically targeted treatments for Duchenne muscular dystrophy during years in which the drugs were marketed without completed confirmatory studies. [ABSTRACT FROM AUTHOR]

This work discusses initiatives designed to capture the value of public investment that will result in an accurate, comprehensive, and transparent paper trail of public funding. [ABSTRACT FROM AUTHOR]

The article focuses on the eroding judicial deference to the Food and Drug Association (FDA) and its consequences for public health. Topics include FDA has operated with deference from courts enshrined by the Supreme Court's landmark case Chevron U.S.A. v. Natural Resources Defense Council; and decisions of the Supreme Court regarding the Environmental Protection Agency and the Occupational Safety and Health Administration (OSHA) will have sweeping implications for public health agencies.

In this Viewpoint, Kesselheim and coauthors discuss 2 bills in Congress that would curtail Medicare's ability to decline, limit, or conditionally cover medical products that lack robust evidence and argue that officials should distinguish between better and worse therapies when determining reimbursement. [ABSTRACT FROM AUTHOR]

Legal challenges to the FDA's approval of mifepristone have destabilized patients' ability to access controversial medicines like medication abortion. We argue that federal courts' receptiveness to this litigation undermines the coherence and integrity of prescription drug regulation in the U.S. [ABSTRACT FROM AUTHOR]