Law Commons^™

The President’S Remedy–What The Hydroxychloroquine Story Teaches Us About The Need To Limit Off-Lable Prescribing Powers, Jennifer Bard

Catholic University Law Review

When the history of the first year of the United States Government’s response to the COVID-19 virus is written, there is likely to be mention of the still unexplained vehemence with which then president Donald J. Trump made use of his access to social media to promote seldom used anti-malaria drug, hydroxychloroquine, for both the prevention and treatment of COVID-19 despite the active growing opposition of most of the world’s scientists, including his own government scientists. While the use of drugs developed and approved by the FDA for different purposes to combat new diseases, off-label prescribing, is legal in the …

Informed Consent As Compelled Professional Speech: Fictions, Facts, And Open Questions, Nadia N. Sawicki

Nadia N. Sawicki

No abstract provided.

A Right To Know How You'll Die: A First Amendment Challenge To State Secrecy Statutes Regarding Lethal Injection Drugs, Kelly A. Mennemeier

Journal of Criminal Law and Criminology

In the years since 2008, when the Supreme Court upheld the constitutionality of a commonly used lethal injection protocol in Baze v. Rees, states have shifted away from the approved protocol and turned towards new drugs, drug protocols, and drug sources to carry out state-sponsored executions by lethal injection. Even as states have shifted to new, untested protocols and less-regulated sources than they used in pre-Baze years, state legislatures have enacted and amended secrecy statutes that hide information about the drug protocols and sources of lethal injection drugs from the press, the public, and condemned prisoners. Meanwhile, a …

The Tip Of The Iceberg: A First Amendment Right To Promote Drugs Off-Label, Christopher Robertson

Faculty Scholarship

Scholars, advocates, and courts have begun to recognize a First Amendment right for the makers of drugs and medical devices to promote their products “off-label,” without proving safety and efficacy of new intended uses. Yet, so far, this debate has occurred in a vacuum of peculiar cases, where convoluted commercial speech doctrine underdetermines the outcome. Juxtaposing these cases against other routine prosecutions of those who peddle unapproved drugs reveals the common legal regime at issue. Review of the seven arguments deployed in the off-label domain finds that, if they were valid, they would undermine the FDA’s entire premarket approval regime. …

Informed Consent As Compelled Professional Speech: Fictions, Facts, And Open Questions, Nadia N. Sawicki

Faculty Publications & Other Works

No abstract provided.

Can Dna Be Speech?, Jorge R. Roig

Jorge R Roig

Digital Medicine, The Fda, And The First Amendment, Adam Candeub

Georgia Law Review

Digital medicine might transform healthcare more fundamentally than the introduction of anesthesia or germ basis theory of disease. Already, tens of thousands of "medical apps" are available for smartphones. These computer applications can measure blood pressure, pulse, lung function, oxygenation level, sugar level, breathing rate and body temperature-and can even diagnose skin cancer, analyze urine, and take an echocardiogram. In fall 2013, the Federal Drug Administration (FDA) asserted regulatory authority over mobile medical applications and other digital medical services, threatening to chill, if not, destroy this innovation. This Article argues that the FDA stands on firm legal ground regulating medical …

Accommodation, Establishment, And Freedom Of Religion, Richard W. Garnett

Richard W Garnett

This short essay engages the argument that it would violate the First Amendment’s Establishment Clause to exempt an ordinary, nonreligious, profit-seeking business – such as Hobby Lobby – from the Affordable Care Act’s contraceptive-coverage rules. In response to this argument, it is emphasized that the First Amendment not only permits but invites generous, religion-specific accommodations and exemptions and that the Court’s Smith decision does not teach otherwise. In addition, this essay proposes that laws and policies that promote and protect religious freedom should be seen as having a “secular purpose” and that because religious freedom, like clean air, is an …

Accommodation, Establishment, And Freedom Of Religion, Richard W. Garnett

Journal Articles

This short essay engages the argument that it would violate the First Amendment’s Establishment Clause to exempt an ordinary, nonreligious, profit-seeking business – such as Hobby Lobby – from the Affordable Care Act’s contraceptive-coverage rules. In response to this argument, it is emphasized that the First Amendment not only permits but invites generous, religion-specific accommodations and exemptions and that the Court’s Smith decision does not teach otherwise. In addition, this essay proposes that laws and policies that promote and protect religious freedom should be seen as having a “secular purpose” and that because religious freedom, like clean air, is an …

Speech As A Weapon: Planned Parenthood V. American Coalition Of Life Activists And The Need For A Reasonable Listener Standard, Alex J. Berkman

Touro Law Review

No abstract provided.

Machine Speech, Tim Wu

Faculty Scholarship

Computers are making an increasing number of important decisions in our lives. They fly airplanes, navigate traffic, and even recommend books. In the process, computers reason through automated algorithms and constantly send and receive information, sometimes in ways that mimic human expression. When can such communications, called here “algorithmic outputs,” claim First Amendment protection?

The Policy Against Federal Funding For Abortions Extends Into The Realm Of Free Speech After Rust V. Sullivan, Loye M. Barton

Pepperdine Law Review

No abstract provided.

The Money Blind: How To Stop Industry Bias In Biomedical Science, Without Violating The First Amendment, Christopher Robertson

Faculty Scholarship

The pharmaceutical and medical device industries use billions of dollars to support the biomedical science that physicians, regulators, and patients use to make healthcare decisions—the decisions that drive an increasingly large portion of the American economy. Compelling evidence suggests that this industry money buys favorable results, biasing the outcomes of scientific research. Current efforts to manage the problem, including disclosure mandates and peer reviews, are ineffective. A blinding mechanism, operating through an intermediary such as the National Institutes of Health, could instead be developed to allow industry support of science without allowing undue influence. If the editors of biomedical journals …

How It Works: Sobriety Sentencing, The Constitution And Alcoholics Anonymous. A Perspective From Aa's Founding Community, Max E. Dehn

ExpressO

This paper analyzes the public health as well as constitutional issues that arise when persons are required by courts to participate in 12-step recovery programs.