Health Law and Policy Commons^™

Puff Puff Pass The Legislation: A Comparison Of E-Cigarette Regulations Across Borders, Rachel E. Zarrabi

Journal of the National Association of Administrative Law Judiciary

This comment explores the types of legislation, approaches to regulating e-cigarettes, and analyzes whether the FDA’s campaign and current regulations are effective. So far, it appears that the United States is ahead of the game with its new, aggressive proposal for regulating e-cigarettes. The FDA is standing against the companies and products that target youthful consumers. Most countries acknowledge the gaps in current scientific research regarding the long-term health risks of vaping, and some are waiting to take a legislative stance until it is clearer which side of the health line e-cigarettes fall. Section II of this comment discusses the …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.

Using And Misusing Legal Decisions: Why Anti-Vaccine Claims About Nvicp Cases Are Wrong, Dorit Rubinstein Reiss, Rachel Heap

Minnesota Journal of Law, Science & Technology

No abstract provided.

Medical Board Of California, Mason Bettencourt, Betsy Gopinath

California Regulatory Law Reporter

No abstract provided.

Department Of Managed Health Care, Kaitlyn Enticknap, Monet Mccord, J. D. Fellmeth

California Regulatory Law Reporter

No abstract provided.

Board Of Registered Nursing, Heather Morse, Bridget Fogarty Gramme

California Regulatory Law Reporter

No abstract provided.

Board Of Pharmacy, John Lacrosse, John Mysliwiec, Bridget Fogarty Gramme

California Regulatory Law Reporter

No abstract provided.

Dental Board Of California, Helene E. Mayer, Bridget Fogarty Gramme

California Regulatory Law Reporter

No abstract provided.

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

DePaul Journal of Health Care Law

No abstract provided.

A Perfect Storm: Religion, Sex, And Administrative Law, Helen M. Alvare

St. John's Law Review

(Excerpt)

In order to propose a way forward toward better sexual and reproductive health regulation, which also avoids undercutting or crossing swords with religion, this Article will proceed as follows: Part I will paint with a broad brush the current state of sexual and reproductive health problems in the United States, focusing a bit upon younger Americans to whom SRA programs are addressed. It will highlight disparities according to race and socioeconomic conditions when these obtain. These are troubling on their face, but particularly troubling today at a time of perceived heightened racial and socioeconomic class tension in the United …

Dental Board Of California, Helene E. Mayer, Debra Jorgensen

California Regulatory Law Reporter

No abstract provided.

Department Of Managed Health Care, Kaitlyn Enticknap, Monet Mccord, Debra Jorgensen

California Regulatory Law Reporter

No abstract provided.

Medical Board Of California, Mason Bettencourt, Debra Jorgensen

California Regulatory Law Reporter

No abstract provided.

Board Of Registered Nursing, Heather Morse, Debra Jorgensen

California Regulatory Law Reporter

No abstract provided.

Board Of Pharmacy, John Lacrosse, John Mysliwiec, Bridget Fogarty Gramme

California Regulatory Law Reporter

No abstract provided.

Pharmaceutical Price Gouging: The Need For Direct Regulation On The Gray Market, Nicole Rende

Journal of Civil Rights and Economic Development

(Excerpt)

This Note proposes federal legislation that will ultimately shut down the Pharmaceuticals gray market. The federal government should directly regulate the gray market and the price gouging mechanisms used. Congress should pass the Fair Accountability and Innovative Research Drug Pricing Act of 2016, currently proposed. This Act will increase price transparency and provide a civil penalty for wrong doers. In addition to the passage of this Act, there needs to be a direct attack on the gray market by creating an act that does not allow companies to participate in these distributions and ultimately form monopolies. This act needs …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.

Digital Health And Regulatory Experimentation At The Fda, Nathan Cortez

Faculty Journal Articles and Book Chapters

For well over a decade the U.S. Food and Drug Administration (FDA) has been told that its framework for regulating traditional medical devices is not modern or flexible enough to address increasingly novel digital health technologies. Very recently, however, the FDA introduced a series of digital health initiatives that represent important experiments in medical product regulation, departing from longstanding precedents applied to therapeutic products like drugs and devices. The FDA will experiment with shifting its scrutiny from the pre-market to the post-market phase, shifting the locus of regulation from products to firms, and shifting from centralized government review to decentralized …

The Costs Of Uncertainty: The Doj’S Stalled Progress On Accessible Medical Equipment Under The Americans With Disabilities Act, Elizabeth Pendo

Articles

Imagine seeking medical care for serious pressure sores for a year, but your doctor never examining the sores because you could not get on the examination table in her office. Or imagine going more than fifteen years without an annual well-woman examination for the same reason, or your doctor guessing at the right dosage for a prescription because there was no scale that she could use to weigh you.

Although these scenarios may be difficult for many to imagine, they are common experiences for individuals with mobility disability. The Trump administration’s attacks on the Patient Protection and Affordable Care Act …

Drugs' Other Side Effects, Craig J. Konnoth

Publications

Drugs often induce unintended, adverse physiological reactions in those that take them—what we commonly refer to as “side-effects.” However, drugs can produce other, broader, unintended, even non-physiological harms. For example, some argue that taking Truvada, a drug that prevents HIV transmission, increases promiscuity and decreases condom use. Expensive Hepatitis C treatments threaten to bankrupt state Medicaid programs. BiDil, which purported to treat heart conditions for self-identified African-Americans, has been criticized for reifying racial categories. Although the Food & Drug Administration (“FDA”) has broad discretion under the Food, Drugs, and Cosmetics Act (“FDCA”) to regulate drugs, it generally considers only traditional …

Predetermined? The Prospect Of Social Determinant-Based Section 1115 Waivers After Stewart V. Azar, Griffin Schoenbaum

Dickinson Law Review (2017-Present)

Section 1115 of the Social Security Act allows the Secretary of Health and Human Services (the “Secretary”) to waive some of Medicaid’s requirements so states can enact “demonstration projects.” A demonstration project is an experiment a state can conduct by modifying aspects of its Medicaid program. To waive Medicaid’s requirements for this purpose, the Secretary must determine that the proposed demonstration project will likely assist in promoting Medicaid’s objectives.

Using this standard, President Trump’s Secretary has approved waiver requests to enact demonstration projects that contain “community engagement” requirements. The U.S. District Court for the District of Columbia has heard each …

Billion Dollar Orphans: Tension Between The Legal Intent And Social Purpose Of The Orphan Drug Act, John Sheridan

Texas A&M Law Review

This Comment examines the extent to which Congress empowered the FDA to address the increase in petitions and the general accessibility of orphan drug remedies. Specifically, this Comment seeks to understand why the FDA’s interpretation of the purpose of the ODA seems to conflict with the statutory intent as interpreted by federal courts. This Comment considers a statute’s ultimate goal or social purpose to be the purpose of the statute, whereas the express mechanisms by which Congress seeks to bring about these goals is best understood as the statute’s intent. To understand the FDA and judiciary’s differing interpretations of the …

The Opioid Crisis: The States' And Local Governments' Response To Bigpharma's Deception And Why The Supremacy Clause May Provide A Cloak For Opioid Manufacturers To Hide Behind, Tracie Childers

Barry Law Review

No abstract provided.

The Vaccine Race In The 21st Century, Ana Santos Rutschman

All Faculty Scholarship

In a world in which infectious diseases are spreading increasingly faster, the development of new human vaccines remains a priority in biopharmaceutical innovation. Legal scholars have addressed different aspects of vaccine regulation and administration, but less attention has been paid to the role of laws governing innovation during the stages of research and development (R&D) of vaccines.

This Article explores the race to develop new vaccines from its beginnings through the early 21st century, with a particular focus on the progressively pervasive role of intellectual property in governing vaccine innovation. It describes the insufficiencies of current innovation regimes in promoting …

Keeping The Healthcare Industry Accountable, Yoori Chung

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

Board Of Pharmacy, Mariam J. Saleh, Bridget Fogarty Gramme

California Regulatory Law Reporter

No abstract provided.

Veterinary Medical Board, Bryan Yerger, Bridget Fogarty Gramme

California Regulatory Law Reporter

No abstract provided.

Medical Board Of California, Kayla Watson, J. D. Fellmeth

California Regulatory Law Reporter

No abstract provided.

Department Of Managed Health Care, Jennifer Pardue, J. D. Fellmeth

California Regulatory Law Reporter

No abstract provided.

Board Of Registered Nursing, Ashkan Hayatdavoudi, Bridget Fogarty Gramme

California Regulatory Law Reporter

No abstract provided.