Lawsuits Over the Price of Insulin-State Efforts for Insulin Access.

This Viewpoint discusses the litigation strategy of state-initiated lawsuits alleging illegal and immoral conduct regarding the pricing of insulin by pharmaceutical companies and pharmacy benefit managers.

The story of the development of generic lenalidomide: How one company thwarted the Hatch-Waxman Act to generate billions of dollars in revenue.

Lenalidomide (Revlimid®) was originally approved by the Food and Drug Administration (FDA) in 2005, however, a generic version was not available until 2022. In that time, the price of lenalidomide has increased more than 20 times, and in 2021 alone, it accounted for >$5.8 billion dollars in Medicare Part D spending. This was a direct consequence of legal tactics employed by the manufacturer to thwart development of generic formulations of lenalidomide. In this report, we review the clinical development of lenalidomide, provide background on generic drug manufacturing in the United States (US), describe the steps that the manufacturer took to prevent entry of generic lenalidomide into the US market, and advocate for legislative reform of the FDA approval process and patent law protections in the US.

Ten years post-GAO assessment, FDA remains uninformed of potentially harmful GRAS substances in foods.

It has been approximately 10 years since the Government Accountability Office (GAO) published its report to Congress entitled, FDA Should Strengthen Its Oversight of Food Ingredients Determined to be Generally Recognized as Safe (GRAS), which strongly criticized FDA noting that its "oversight process does not help ensure the safety of all new GRAS determinations." Congress requested GAO to undertake this audit as a result of concerns that GRAS substances added to foods did not require FDA approval. Since 2010, FDA has addressed only a few of the criticisms regarding its process for establishing a food substance as GRAS. However, several of the most important GAO recommendations remain unaddressed, and most critically, FDA has chosen to remain uninformed about food substances self-determined as GRAS by manufacturers. In its 2016 final rule Substances Generally Recognized as Safe, FDA did not take the opportunity to include a provision for creation of a master list of all GRAS chemicals used in food, nor did the FDA request the authority to do so from Congress. FDA cannot fulfill its statutory obligation for ensuring the chemical safety of the U.S. food supply if it does not know which substances, in which quantities, have been added to foods.

Sponsorship of National Health Organizations by Two Major Soda Companies.

INTRODUCTION: Obesity is a pervasive public health problem in the U.S. Reducing soda consumption is important for stemming the obesity epidemic. However, several articles and one book suggest that soda companies are using their resources to impede public health interventions that might reduce soda consumption. Although corporate sponsorship by tobacco and alcohol companies has been studied extensively, there has been no systematic attempt to catalog sponsorship activities of soda companies. This study investigates the nature, extent, and implications of soda company sponsorship of U.S. health and medical organizations, as well as corporate lobbying expenditures on soda- or nutrition-related public health legislation from 2011 to 2015. METHODS: Records of corporate philanthropy and lobbying expenditures on public health legislation by soda companies in the U.S. during 2011-2015 were found through Internet and database searches. RESULTS: From 2011 to 2015, the Coca-Cola Company and PepsiCo were found to sponsor a total of 95 national health organizations, including many medical and public health institutions whose specific missions include fighting the obesity epidemic. During the study period, these two soda companies lobbied against 29 public health bills intended to reduce soda consumption or improve nutrition. CONCLUSIONS: There is surprisingly pervasive sponsorship of national health and medical organizations by the nation's two largest soda companies. These companies lobbied against public health intervention in 97% of cases, calling into question a sincere commitment to improving the public's health. By accepting funding from these companies, health organizations are inadvertently participating in their marketing plans.

Access to resources for substance users in Harlem, New York City: service provider and client perspectives.

The Urban Research Center (URC) in Harlem, New York City, is a collaboration of community members, service providers, and academics. A Community Advisory Board (CAB) meets regularly to formulate priorities for action and to direct research. A conceptual model of social determinants of health relevant to the Harlem community was developed. Early meetings of the CAB identified substance use as a health concern in the Harlem community. Access to social services was identified as a key social determinant that should guide research and intervention efforts of the URC. Surveys of service providers and of substance users were carried out to quantify availability of information and barriers to access. This article discusses the CAB process that led to the model of social determinants, development of surveys, and interpretation of results. The authors also discuss survey results and how the URC will use these results to develop interventions.