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Health Law and Policy

Faculty Publications & Other Works

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FDA

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Articles 1 - 4 of 4

Full-Text Articles in Law

Biosimilar Bias: A Barrier To Addressing American Drug Costs, Cynthia M. Ho Jan 2022

Biosimilar Bias: A Barrier To Addressing American Drug Costs, Cynthia M. Ho

Faculty Publications & Other Works

Forty percent of spiraling US drug costs are based on a mere two percent of all drugs –biologic drugs (biologics) made from living cells that are administered by injection or infusion. These costs will continue to balloon as new biologics are approved; the recently approved Alzheimer’s drug is expected to result in a 50% increase in Medicare spending and cost individuals 40% of their annual income. These drugs are expensive because they cannot be mass-produced, and their cost places important treatments for conditions such as arthritis (Humira) and cancer (Herceptin) out of reach for many Americans. Fortunately, just as there …


A Dangerous Concoction: Pharmaceutical Marketing, Cognitive Biases, And First Amendment Overprotection, Cynthia M. Ho Jan 2019

A Dangerous Concoction: Pharmaceutical Marketing, Cognitive Biases, And First Amendment Overprotection, Cynthia M. Ho

Faculty Publications & Other Works

This Article argues that pharmaceutical marketing to doctors should be more critically evaluated and entitled to less First Amendment protection, contrary to a trend dating back to the Supreme Court's 2011 decision in Sorrell. In particular, the Article argues that more information to doctors in the form of pharmaceutical marketing does not necessarily result in better patient outcomes. The Article adds a significant critique based on the existence and impact of cognitive bias literature that has thus far not been recognized in this area. If courts fully embrace this understanding, they should recognize that the government, through the Food and …


Public Health Preparedness & Response: An Exercise In Administrative Law, John D. Blum, Jordan Paradise Jan 2018

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 …


Cultivating Innovation In Precision Medicine Through Regulatory Flexibility At The Fda, Jordan Paradise Jan 2017

Cultivating Innovation In Precision Medicine Through Regulatory Flexibility At The Fda, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.