Food policy action on the state and local levels is necessary and important for at least two reasons. First, the complexity and breadth of our nation's food system requires layered policy and regulation: the system's functioning needs both national uniformity and local distinctions. Second, there are crucial gaps in national regulation that provide rich opportunities for state and local action. These gaps, in areas such as the regulation of antibiotics in animal feed and the oversight of food additives, are not priorities of the federal agencies that oversee food. Although the Food and Drug Administration (FDA) has made nutrition policy a priority for 2018, the current administration's explicitly anti-regulatory agenda makes it unlikely that it will address these previously under prioritized areas.

In May 2015, the first baby created through an emerging ova technology called AUGMENT, was born in Canada.1 Developed by OvaScience, AUGMENT essentially introduces mitochondria sourced from the genetic mother into her own ovum in order to revitalize the ovum.2 This technology is controversial because OvaScience is a publicly traded company, and it is driven by short-term results, such as earnings;3 and (2) OvaScience did not complete adequate clinical trials before offering AUGMENT to the public.4 Moreover, in its 2014 annual report, OvaScience declared that it was intentionally offering its products in countries where clinical trials are not required.5 The lack of adequate clinical trials is the primary reason underlying the Food and Drug Administration's (“FDA”) prohibition of the technology in the United States.6 Finally, as of August 2018, OvaScience has shifted its research away from AUGMENT, and it only offers it through an “exclusive license to IVF Japan Group in Japan.”7

Basic principles of economics suggest that health insurers should seek to avoid covering sick individuals and attempt to minimize the amount they have to spend if, despite the insurer's best efforts, such individuals enroll in coverage. The drafters of the Affordable Care Act recognized this natural tendency of insurers and put in place multiple provisions aimed at avoiding such behavior. One such tool was the requirement that all health insurers in the individual and small group markets cover an identical, comprehensive set of benefits known as the Essential Health Benefits (“EHBs”). EHBs were designed to ensure that consumers are able to access comprehensive coverage, but also to prevent insurers from trying to avoid high-risk enrollees by designing plans that appeal only to the healthy. Congress did not, however, statutorily define the full package of benefits, instead delegating primary authority for that task to the Department of Health & Human Services (“HHS”). This article argues that HHS has implemented the EHB requirements in a manner that appears structurally incapable of achieving the goals of the statute. By utilizing a vague definition of benefits, allowing benefit substitutions, and failing to limit use of service-level selection tools, HHS has permitted insurers to compete for low-risk insureds, avoid paying for certain high-cost treatments, and prevented consumers from making fully informed purchasing decisions.

Voice in healthcare is crucial because of its ability to improve organizational performance and prevent medical errors. This paper contends that a comparative analysis of voice promotion in the American and German healthcare industries can strengthen a culture of safety in both countries. It provides a brief introduction to the concept of voice in healthcare, including its impact on safety culture, barriers to voice, and the dual influences of confidentiality and transparency on voice promotion policies. It then examines the theoretical basis, practical workings, and legal aspects of voluntary error reporting and error disclosure as avenues for exercising voice in the U.S. and Germany. Finally, it identifies transferable practices that can remedy shortcomings in each country's voice promotion policy.

Biomarkers are an important tool in modern drug development. The FDA has posited that increased use of biomarkers in clinical trials can accelerate pharmaceutical industry productivity, ushering new drugs to market. Accordingly, the FDA has created two pathways for evaluation of biomarker utility. Biomarkers incorporated into clinical trials, the traditional pathway, are effectively private to a therapeutic sponsor and to the scope of the trial. By contrast, in Biomarker Qualification (“BQ”), the second pathway, a biomarker is certified as a publicly available tool. The FDA has hoped that academic, non-profit, and industry stakeholders would work together in consortia to qualify biomarkers, cumulatively generating a common resource of broad utility. In practice, utilization of Biomarker Qualification has been paltry. Incentives for BQ that align with the interests of industry resource holders are necessary to fuel increased utilization of biomarkers in clinical trials and create the communal biomarker toolkit envisioned by the FDA. A blanket extension of exclusivity for any drug successfully paired with a companion biomarker would diminish public access to medicine by encouraging spurious biomarkers and correspondingly narrowed clinical trials. As a measured alternative, an exclusive right to include a qualified companion biomarker on an FDA drug label would balance public access externalities. This exclusivity would waylay label approval, and thus marketability, of later drugs relying on the qualified biomarker for clinical safety or efficacy. Accordingly, sponsors would find no incentive to portage an ineffective or unnecessary biomarker through clinical trials, as there would be no benefit to securing exclusive rights in a tool others saw no value in using.