Despite some improvements in access to evidence-based medications for opioid use disorder, treatment rates remain low at under a quarter of those with need. High costs for brand name products in these medication markets have limited the volume of drugs purchased, particularly through public health insurance and grant programs. Brand firm anti-competitive practices around the leading buprenorphine product Suboxone — including product hops, citizen petitions and Risk Evaluation and Mitigation Strategy abuses — helped to maintain high prices (...) by extending brand exclusivity periods and hindering generic drug entry. Remedies to address costly anti-competitive activities include adoption of the proposed CREATES Act and modernization of the Hatch-Waxman Act by the Congress, and implementation of substantive modifications to the Food and Drug Administration citizen petition filing procedures. Given the persistence of these abuses, prescriptive changes are favorable to the procedural and clarifying steps thus far favored by the federal government. Extrapolating from the 37% price declines attributable to generic entry for buprenorphine tablets in 2011, our calculations suggest that implementing these remedies to facilitate generic competition with Suboxone film would have resulted in savings of approximately $703 million overall and $203 million to Medicaid in 2017. (shrink)

This article explores the role of the Food and Drug Administration (FDA) in drug approval and restrictions to mifepristone access in the context of historical regulation and current litigation.

This article investigates the hypothesis that greater human-livestock intimacy can deter cruelty and mitigate suffering in the industrial production of animals for human consumption. The history of industrial agriculture in North America is one of increasingly utilitarian, profit-based, and technologically mediated relationships between humans and the animals they raise and kill for food. Under what circumstances is the physical and emotional distance between producers, consumers, and consumed animals an impetus toward uncaring and irresponsible relationships? Do even intimate interspecies encounters (...) in livestock production involve cruelty and suffering? This article addresses these questions and evaluates reform options by attending to both the localized arrangements and systemic structures of industrial livestock production. Finally, it proposes a risk-mapping strategy to assess the plausibility of caring intimacies in livestock production. (shrink)