Health Law and Policy Commons^™

Will Courts Allow States To Regulate Drug Prices?, Christopher Robertson

Faculty Scholarship

Pharmaceuticals are consuming increasingly large portions of U.S. state budgets, and high prices are preventing patients from getting, and adhering to, essential medicines. In mid-May 2018, President Donald Trump announced a heavily hyped but relatively modest federal plan to bring down drug prices. Meanwhile, several states are moving forward with their own solutions, and Maryland’s approach is particularly ambitious. In 2017, responding to notorious cases such as the 5000% increase in the cost of Daraprim (pyrimethamine) and the 10-fold increase in the cost of EpiPens (epinephrine auto-injectors), Maryland enacted a statute that prohibits manufacturers from “price gouging” on any “essential …

Dying To Be Fresh And Clean? Toxicants In Personal Care Products, The Impact On Cancer Risk, And Epigenetic Damage, Katherine Drabiak

Pace Environmental Law Review

The FDA does not conduct pre-market review of chemicals contained in cosmetics—which encompasses not only makeup but also numerous personal care products including shampoo, lotion, perfume, aftershave, and shaving cream. Every day, consumers use cosmetic products that contain a variety of synthetic ingredients, none of which the FDA has approved for safety but each of which are being ingested, absorbed, and inhaled into our bodies and accumulating in our tissue. Many of these products contain endocrine disrupting chemicals (“EDCs”), which emerging research links to an increased risk of cancer as well as immune and neurological dysfunction. This Article examines how …

Emerging Governance Of Mitochondrial Replacement Therapy: Assessing Coherence Between Scientific Evidence And Policy Outcomes, Katherine Drabiak

DePaul Journal of Health Care Law

In the fall of 2016, media headlines reported news of several births of children born through “three parent IVF” or mitochondrial replacement therapy (MRT). MRT refers to an experimental procedure that entails removing the nuclear DNA from the mother’s egg or fertilized zygote and transferring it to a donor’s egg or fertilized zygote. This procedure constitutes a modification of the human germline, which has been prohibited by numerous declarations, directives, and laws promulgated by the United Nations, the Council of Europe, and other nations. In 2016, the Human Fertilisation and Embryology Authority in the United Kingdom was the first nation …

Fighting For Your Life In America: A Study Of "Right To Try" Laws Throughout The Country, Danielle Delgrosso

St. John's Law Review

(Excerpt)

This Note argues that there should be a federal statute granting terminally ill patients access to experimental drugs, but that the Trickett Wendler Act, as written is not the proper vehicle for change. An ideal congressional “Right to Try” statute should be crafted to make experimental drugs realistically obtainable for terminally ill patients while protecting those patients and their quality of life. The Trickett Wendler Act’s weaknesses prevent it from reaching this objective because it is too deferential to already unclear state Right to Try laws. Part I explores the right to try movement generally, explaining what a “right …

The Faltering Promise Of Fda Tobacco Regulation, Micah L. Berman

Saint Louis University Journal of Health Law & Policy

Congress passed the Tobacco Control Act (TCA) in 2009, giving the FDA the authority to regulate tobacco products for the first time. Ten years later, the promise that the TCA’s enactment would be a transformative moment for public health has not materialized. To the contrary, the FDA’s most notable regulatory effort—requiring graphic warnings on cigarette packages and advertisements—has been struck down in court, and the FDA is now scrambling to address a youth e-cigarette epidemic that caught it off guard. This Article provides a brief review of TCA implementation during the Obama administration, and it reviews the Trump administration’s “comprehensive …

Public Health Preparedness & Response: An Exercise In Administrative Law, John D. Blum, Jordan Paradise

Faculty Publications & Other Works

Responses to epidemics, pandemics, and other biological disasters require multiple coordinated initiatives that combine sophisticated planning, sound emergency management, effective stockpiles, solid geographic information systems, well-developed laboratory surveillance and response, and effective management capabilities. Critical to the noted elements of planning and response is the existence of a legal structure, which underpins the operations of necessary programs. While the law may not be the first public health tool considered in a disaster, it is fundamental to the effective functioning of multiple actors and must be harmonized across jurisdictional lines. This article explores the role of law in pandemics and other …

Securing The Internet Of Healthcare, Michael Mattioli, Scott J. Shackelford, Steve Myers, Austin Brady, Yvette Wang, Stephanie Wong

Articles by Maurer Faculty

Cybersecurity, including the security of information technology (IT), is a critical requirement in ensuring society trusts, and therefore can benefit from, modern technology. Problematically, though, rarely a day goes by without a news story related to how critical data has been exposed, exfiltrated, or otherwise inappropriately used or accessed as a result of supply chain vulnerabilities. From the Russian government's campaign to influence the 2016 U.S. presidential election to the September 2017 Equifax breach of more than 140-million Americans' credit reports, mitigating cyber risk has become a topic of conversation in boardrooms and the White House, on Wall Street and …