Journal of Law Medicine & Ethics最新文献

Interventional clinical studies of convalescent plasma to treat COVID-19 were predominantly funded and led by public sector actors, including blood services operators. We aimed to analyze the processes of clinical studies of convalescent plasma to understand alternatives to pharmaceutical industry biopharmaceutical research and development, particularly where public sector actors play a dominant role. We conducted a qualitative, critical case study of purposively sampled prominent and impactful clinical studies of convalescent plasma during 2020-2021.

Our paper examines what is required to protect and promote effective public discussion and policy development in the current climate of divisive disagreement about many public policy questions. We use abortion as a case example precisely because it is morally fraught. We first consider the changes made by Dobbs, as well as those which led up to the Dobbs decision, accompany it, and follow from it.

In a "mixed bag" 2023-2024 session, the U.S. Supreme Court issued a series of decisions both favorable and antithetical to public health and safety. Taking on tough constitutional issues implicating gun control, misinformation, and homelessness, the Court also avoided substantive reviews in favor of procedural dismissals in key cases involving reproductive rights and government censorship.

May 11, 2023, marked the end of the federal COVID-19 Public Health Emergency (PHE). During the PHE, regulatory flexibilities allowed telehealth to more effectively connect physicians providing care and patients seeking it. This paper discusses the implications of the end of the PHE on telehealth coverage, payment, reimbursement, and licensure, and exposes inconsistencies and inequities in extant state regulations.

This article analyzes trends in drug shortages in the US and Germany, the largest pharmaceutical market in Europe, between 2016 and 2023. It assesses the commonalities and differences between the countries in terms of active substances in shortage, time duration in shortage, and cyclic trends.

The US has found it hard to establish competition in the market for biologics, which are therapeutics derived from living cells. In the case of small-molecule drugs, the emergence of direct competition from generic drugs at the end of the exclusivity period has provided the impetus for price competition, leading to lower spending. In 2010, to spur competition in the biologics market, Congress created a simplified pathway for the US Food and Drug Administration (FDA) to approve comparable versions of biologic drugs called biosimilars. Biosimilar competition in the US has nonetheless remained weaker than in European peer countries. For example, as of August 2020, there were 52 biosimilars available in Germany, and only 15 in the US.¹ An important contributor to this "biosimilar gap" has been the fact that biosimilars to biologic blockbusters such as adalimumab (Humira) and etanercept (Enbrel) were only (or will only become) commercially available in the US several years after receiving FDA approval, while they were available in Europe years earlier.² Through the end of 2021, it took biosimilars a median of 301 days between receiving FDA approval and becoming available for use.³ In one recent study, the median length of time between when a biologic drug was approved and when its first biosimilar was made available to US patients was 21.5 years.⁴ This paucity of competition has contributed to high US spending on biologics. According to the Department of Health and Human Services, in 2022 41% of US drug expenditures was spent on biologics, which represented 16% of US prescriptions.⁵.

In recent years, the Minnesota Attorney General's Office and the Minnesota Department of Health have cultivated a productive partnership to strengthen the state's multidisciplinary response to overlapping health equity and social justice issues. This article describes shared efforts in three areas: post-conviction justice, drug overdose, and human trafficking/exploitation.

In 2021, there were 11.7 million licensed young drivers in the U.S. This is 1.5 million fewer young drivers compared to 2007. The phenomenon of delay in driving licensure among teens has notable implications for opportunities positioning them for life success when transitioning into emerging adulthood and in later life.

The new federal Pregnant Workers Fairness Act advances important protections for pregnant workers, but leaves behind agricultural workers, who are overrepresented in hazardous occupational environments. This article highlights the connection between workplace pregnancy discrimination and health inequities. It concludes with a discussion of immigrant-led advocacy efforts to eliminate health inequities and advance health justice.