Privileges, Immunities, and Affirmative Action in Medical Education

In Students for Fair Admissions v. President & Fellows of Harvard College and Students for Fair Admissions v. University of North Carolina, the Supreme Court ruled that affirmative action in university admissions, in which an applicant of a particular race or ethnicity receives a plus factor, is unconstitutional. This ruling was based on both the Equal Protection Clause of the Fourteenth Amendment and Title VI of the Civil Rights Act of 1964. This article argues that a more natural fit as the basis for constitutional analysis would be a different clause in the Fourteenth Amendment, the Privileges or Immunities Clause. In the article, a legal analysis based on the clause is applied to medical school admissions. Depending on whether a fundamental rights reading or an antidiscrimination (equality) reading of the clause is applied, opposite conclusions are reached on the constitutionality of affirmative action in medical school admissions. This analysis demonstrates why affirmative action in admissions—in this case medical school admissions, which directly affect the composition of the Nation’s physician workforce—is a complex and difficult constitutional question

Battling Over Patents: The Impact of Oil States on the Generic Drug Industry

In the 2018 case of Oil States Energy Services v. Greene’s Energy Group, the U.S. Supreme Court upheld the constitutionality of inter partes review, a non-judicial proceeding for challenging patents that was created by Congress as part of the 2011 Leahy-Smith America Invents Act. By establishing inter partes review, Congress hoped to rebalance patent policy to make it faster and less costly to invalidate erroneously granted patents in all fields of technology. In the pharmaceutical industry, generic drug companies have embraced inter partes review, filing hundreds of challenges in the first five years after its creation, with moderate success. Biologics, which make up a growing class of pharmaceutical products, are sometimes covered by dozens or scores of patents. As more of these complex therapeutics are developed and approved, inter partes review is expected to play an increasingly important role

Icosapent ethyl: scientific and legal controversies

Icosapent ethyl (Vascepa) is a purified preparation of the omega-3 fatty acid eicosapentaenoic acid, which is marketed by Amarin Pharma based in Ireland. The product was initially approved by the US Food and Drug Administration for the use of a high dose (4 g/day) in the treatment of hypertriglyceridaemia. On the basis of the results of the REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl Intervention Trial), the agency later granted a label extension to include the additional indication of a reduction in risk of cardiovascular events in persons with serum triglyceride levels of 150 mg/dL or greater and established cardiovascular disease or diabetes. Data supporting the efficacy of omega-3 fatty acids in the prevention of cardiovascular disease have been inconsistent and controversial. The story of the development of icosapent ethyl has been fraught with challenges, including the invalidation of six core patents on the product, and recently, the completion of a new clinical trial, STRENGTH (Long-Term Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia), that directly contradicts REDUCE-IT and calls into question whether icosapent ethyl is actually effective in the secondary prevention of cardiovascular events. This article traces the course of the development of this fascinating product and discusses its complex medical, regulatory and legal history, which is still continuing to unfold

9. Financial associations of authors

N Engl J Med. 2002;346(24):1901-2