Political Subdivisions, Homelessness, and Vacancy: How Missouri’s Use of Logrolling Passed House Bill 1606

In June of 2022, Governor Parson signed into law House Bill 1606. HB 1606 contains a diverse set of provisions concerning county financial statements, unlawful camping on state-owned property, and penalties for landowners of vacant property. In this article, Kateri Busiek discusses how House Bill 1606 violates the Missouri Constitution.https://scholarship.law.slu.edu/lawjournalonline/1113/thumbnail.jp

Public Health Product Hops

Pharmaceutical product hops are anticompetitive maneuvers that often represent a last-ditch effort by brand manufacturers to preserve market share in the face of generic competition. An integral part of product life cycle management strategies, product hops may offer marginal benefits to patients but can substantially increase costs to payers and patients alike. Yet industry advocates maintain that this is essential follow-on research and development, resulting in the development of novel products that would otherwise never reach the market. Is there a middle ground between these two diametrically opposed views? Might certain product hops be considered beneficial, perhaps if they furthered important public health interests? Sometimes product hops arise due to safety concerns raised by FDA or pressure from other public health agencies. For instance, a push from Congress and the EPA to remove chlorofluorocarbons from all consumer and industrial products resulted in a switch from chlorofluorocarbon to hydrofluoroalkane propellants in respiratory inhalers. In another instance, concerns about the opioid crisis fueled the development of abuse-deterrent formulations of opioids as part of a public health response to the crisis. Despite the public health motivations driving each scenario, I find that some public benefit may have been achieved, but at substantial expense to both payers and patients. I explore the potential benefits of a “public health product hop” in more detail using the recent push to approve over-the-counter versions of intranasal naloxone as a case study. I develop a framework for rewarding product hops that provide a meaningful and quantifiable public health benefit. In these instances, I argue for time-limited patent incentives that more equitably reward manufacturers for advancing important public health-goals while ending regulatory incentives for purely profit-driven product hops

Upholding Longstanding Prohibitions on Firearm Possession Under Bruen

The Supreme Court’s decision in New York State Rifle & Pistol Association, Inc. v. Bruen has cast doubt on the constitutionality of federal firearms possession laws, such as the prohibition on felons possessing guns. This piece examines how one federal district court upheld a federal restriction on felon gun possession in the recent wake of the Bruen decision. In this article, Mitchell Gordon especially focuses on the historical facts and analysis that are now required under Bruen in order to uphold a governmental restriction on Second Amendment rights.https://scholarship.law.slu.edu/lawjournalonline/1117/thumbnail.jp

Re-Regulating Dietary Supplements

In 1994, Congress introduced the Dietary Supplement Health and Education Act (DSHEA) to create a regulatory framework for the dietary supplement industry. Since the passage of DSHEA nearly thirty years ago, U.S. adults have steadily increased their annual consumption of dietary supplements. The once $4 billion industry comprising approximately 4,000 products has swelled to a$40 billion trade with anywhere from 50,000 to 80,000 dietary supplements available over-the-counter. Despite the increased market size of dietary supplements, the Food and Drug Administration’s (FDA) pre-market authority to regulate the introduction of dietary supplements into the stream of commerce has remained subdued. Under DSHEA, the FDA has limited authority to review dietary supplements before entering the market. Unlike pharmaceuticals, which must be shown to be safe and effective prior to approval and marketing, dietary supplements can be sold to consumers without such reassurances. Instead, the FDA’s authority is generally limited to post-market enforcement under DSHEA. In fact, the FDA lacks the express authority to remove dietary supplements from the market unless it can establish that the products are unsafe, adulterated, mislabeled or misbranded. Given the morbidity and mortality associated with adulterated dietary supplements and the challenges in addressing the latest fads before they cause harm, Congress must give the FDA the power it needs to be proactive. The FDA desperately needs the tools to regulate the dietary supplement industry and remove harmful dietary supplements from the market. We call on Congress to amend DSHEA to grant the FDA the express statutory authority to (1) regulate dietary supplements prior to entering the market; (2) require manufacturers to submit Supplement Labels to the FDA for pre-market review; (3) require that supplements undergo both pre-market composition testing and post-market randomized composition testing; (4) strengthen agency authority to remove adulterated dietary supplements from the market; and (5) establish an excise tax on dietary supplements

The Battle for Medicare

America is aging. From 2019 to 2060, the total population of Americans over sixty-five will grow from fifty-four million to ninety-five million. Of all Americans, sixteen percent were aged sixty-five and older in 2019; nearly twenty-two percent are projected to be in this age group by 2040. This shift will put unprecedented pressure on the Medicare program. Its enrollment is already in the midst of an unparalleled boom, growing from forty-eight million in 2010 to eighty-six million by just 2035. As it grows in importance and size, the future of Medicare will be dominated by two competing pressures. First, Medicare has become the primary regulatory vehicle for the federal government and the executive branch in American health care. Its importance as an engine of regulation is highlighted by political gridlock and Medicare’s reach. Congressional inaction continues to stymie common-sense health policy development. And, theoretically, one federal dollar—flowing into a hospital’s revenues or a provider’s pocket—unlocks the extensive regulatory pressure of the Medicare program. Second, the countervailing force is a global deregulatory regime seeking to roll back the administrative state. This regime is most specifically embodied by a newly emboldened Supreme Court, which has signaled hostility to the power and reach of federal agencies. As Medicare becomes more central—and, as it becomes more conspicuous as the primary regulatory vehicle in American health care—it becomes a target of this larger deregulatory project. A recent example of both Medicare’s use as a regulatory engine and the hostility to its regulatory power is the Centers for Medicare and Medicaid Services’ (“CMS’s”) recent COVID-19 vaccination mandate for health care workers, and the resulting litigation in federal courts. This essay examines this tension by highlighting the judiciary’s treatment of President Biden’s vaccination mandate policy while summarizing Medicare’s unique position in health care law and policy. These fights between a robust Medicare program and a global deregulatory effort—perhaps dismissed as academic—will have a real impact on the health and health care of millions of Americans. Regardless of the ultimate resolution of these fights over power and policy, Medicare will serve as the location for turbulent fights over law and power, policy, and values for years to come

Running a Different Route: How YouTube TV Plans to Avoid Antitrust Violations

After reaching a deal this past December, YouTube TV is now the sole option for NFL Sunday Ticket subscribers. By providing out-of-market sports games in a bundled package, YouTube TV runs the risk of violating the Sherman Antitrust Act. In this article, Brody Shea addresses how YouTube TV can avoid future litigation.https://scholarship.law.slu.edu/lawjournalonline/1110/thumbnail.jp