Health Law and Policy Commons^™

Memorandum Re: Health Canada's 'Draft Guidance' On Section 21.1(3)(C) Of The Food And Drugs Act, Matthew Herder, Trudo Lemmens

Reports & Public Policy Documents

In 2014 Parliament enacted a number of amendments to the Food and Drugs Act, R.S.C. 1985, c. F-27 [hereinafter the “F&D Act”]. Known as “Vanessa’s Law,” these amendments were intended to enhance the regulation of pharmaceutical drugs and thereby protect Canadians from harm by giving the regulator, Health Canada, new powers to, inter alia, recall drugs, require active post-market surveillance, and improve the transparency of information around pharmaceutical drugs. Vanessa’s Law explicitly recognized that “new measures are required to further protect Canadians from the risks related to drugs and medical devices.” (emphasis added) (Bill C-17, An Act to Amend the …

Medicine As A Public Calling, Nicholas Bagley

Michigan Law Review

The debate over how to tame private medical spending tends to pit advocates of government-provided insurance—a single-payer scheme—against those who would prefer to harness market forces to hold down costs. When it is mentioned at all, the possibility of regulating the medical industry as a public utility is brusquely dismissed as anathema to the American regulatory tradition. This dismissiveness, however, rests on a failure to appreciate just how deeply the public utility model shaped health law in the twentieth century— and how it continues to shape health law today. Closer economic regulation of the medical industry may or may not …

Fracking And The Rural Poor: Negative Externalities, Failing Remedies, And Federal Legislation, Matthew Castelli

Indiana Journal of Law and Social Equality

This Note examines the relationship between the rural poor and the negative externalities of hydraulic fracturing (“fracking”). It asserts that the rural poor are disproportionately burdened with fracking’s negative externalities and that comprehensive, national regulation is needed because current legal methods are insufficient to internalize these costs. The argument is made in four parts: describing fracking’s externalities; assessing their impact on the rural poor; analyzing current legal regimes; and proposing an equitable regulatory framework based on cooperative federalism.

Fracking produces three main categories of negative externalities: water, air, and land contamination. Water contamination can be caused by migration of fracking …

Adopting An International Convention On Surrogacy—A Lesson From Intercountry Adoption, Seema Mohapatra

Faculty Scholarship

No abstract provided.

Adopting An International Convention On Surrogacy—A Lesson From Intercountry Adoption, Seema Mohapatra

Faculty Scholarship

No abstract provided.

Can You Diagnose Me Now? A Proposal To Modify The Fda’S Regulation Of Smartphone Mobile Health Applications With A Pre-Market Notification And Application Database Program, Stephen Mcinerney

University of Michigan Journal of Law Reform

Advances in mobile technology continually create new possibilities for the future of medical care. Yet these changes have also created concerns about patient safety. Under the Food, Drug, and Cosmetic Act, the Food and Drug Administration (FDA) has the authority to regulate a broad spectrum of products beyond traditional medical devices like stethoscopes or pacemakers. The regulatory question is not if the FDA has the statutory authority to regulate health-related software, but rather how it will exercise its regulatory authority. In September 2013, the FDA published Final Guidance on Mobile Medical Applications; in it, the Agency limited its oversight to …

Introducing New Users To An Old Poison: The Tobacco Industry’S Efforts To Thwart The Fda’S Regulation Of E-Cigarettes, Jennifer S. Bard

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Deregulation, Distrust, And Democracy, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

Environmental, public health, alternative food, and food justice advocates are working together to achieve incremental agricultural subsidy and nutrition assistance reforms that increase access to fresh fruits and vegetables. When it comes to targeting food and beverage products for increased regulation and decreased consumption, however, the priorities of various food reform movements diverge. This article argues that foundational legal issues, including preemption of state and local authority to protect the public's health and welfare, increasing First Amendment protection for commercial speech, and eroding judicial deference to legislative policy judgments, present a more promising avenue for collaboration across movements than discrete …

For The Love Of The Game: The Case For State Bans On Youth Tackle Football, Adam Bulkley

University of Michigan Journal of Law Reform Caveat

This football season, millions of Americans enjoying their favorite pastime might feel pangs of a guilty conscience. Years of scientific research into the long-term neurological effects of tackle football and a recent settlement between the National Football League (NFL) and thousands of retired NFL players have made football-related traumatic brain injuries (TBI) a topic of national conversation. Current and former NFL players and even President Obama have participated in the conversation, saying that they would hesitate to let their sons play the game for fear of possible brain injury. Because research has uncovered signs of permanent brain damage in players …

The Missing Link: U.S. Regulation Of Consumer Cosmetic Products To Protect Human Health And The Environment, Valerie J. Watnick

Pace Environmental Law Review

This article explores these lax regulatory efforts and their connection to risk assessment, and proposes changes to our current toxics regulatory paradigm. Part I of this article explores our current regulatory approach for consumer cosmetics. Part II discusses the specific and dire concerns regarding chemicals that are suspected carcinogens and those suspected of disrupting the human endocrine system. The article argues in Part III that because the framework for our current regulation of consumer cosmetic products is not designed to be protective of human health, our regulatory paradigm must shift dramatically in the future if this is to become our …

Protecting Human Health And Stewarding The Environment: An Essay Exploring Values In U.S. Environmental Protection Law, Tracy Bach

Michigan Journal of Environmental & Administrative Law

The purpose of this conference is to explore “the relationship between environmental protection and public health and how it should inform our efforts to become better stewards of the environment.” No one would disagree with the assertion that during the last forty years of federal environmental protection, air and water quality have improved and led to concomitant improvements in human health. Exploring the contours of this “relationship,” Environmental Protection Agency (EPA) Administrator Gina McCarthy said in her keynote speech that “[t]he thing is, the word ‘relationship’ is too neutral. The link between the health of our planet and the health …

The Drug Quality And Security Act - Mind The Gaps, Kevin Outterson

Faculty Scholarship

After the compounding pharmacy disaster at New England Compounding Center, Congress had an opportunity to assure that all compounded medicines were safe and effective. The Drug Quality and Safety Act, despite its name, fell short of that mark.

Nudging The Fda, W. Nicholson Price Ii, I. Glenn Cohen

Law Faculty Scholarship

[Excerpt] "The FDA’s regulation of drugs is frequently the subject of policy debate, with arguments falling into two camps. On the one hand, a libertarian view of patients and the health care system holds high the value of consumer choice. Patients should get all the information and the drugs they want; the FDA should do what it can to enforce some basic standards but should otherwise get out of the way. On the other hand, a paternalist view values the FDA’s role as an expert agency standing between patients and a set of potentially dangerous drugs and potentially unscrupulous or …

Mobile Medical App Regulation: Preventing A Pandemic Of “Mobilechondriacs”, Nathaniel R. Carroll

Saint Louis University Journal of Health Law & Policy

No abstract provided.

The Highs Of Tomorrow: Why New Laws And Policies Are Needed To Meet The Unique Challenges Of Synthetic Drugs , Joseph A. Cohen

Journal of Law and Health

This article reviews the federal government’s attempts to control the influx of synthetic drugs, particularly synthetic cannabinoids and cathinones, into the U.S. recreational drug market since 2008. It offers three recommendations targeted at Congress, the DEA, and the Department of State on ways to prevent and control synthetic drug use in America: (1) Congress should grant the DEA a new “immediate scheduling” authority; (2) the DEA should improve information sharing with states; and (3) the Department of State and the DEA should prioritize the development of a global early warning system.

Essential Health Benefits And The Affordable Care Act: Law And Process, Nicholas Bagley, Helen Levy

Articles

Starting in 2014, the Affordable Care Act (ACA) will require private insurance plans sold in the individual and small-group markets to cover a roster of "essential health benefits." Precisely which benefits should count as essential, however, was left to the discretion of the Department of Health and Human Services (HHS). The matter was both important and controversial. Nonetheless, HHS announced its policy by posting on the Internet a thirteen-page bulletin stating that it would allow each state to define essential benefits for itself. On both substance and procedure, the move was surprising. The state-by-state approach departed from the uniform, federal …

The Presumption Against Expensive Health Care Consumption, Christopher Robertson

Faculty Scholarship

This essay, as part of a symposium in honor of Professor Einer Elhauge, starts with his recognition that, for both epistemic and normative reasons, it remains profoundly difficult to regulate particular uses of medical technologies on the basis of their cost-benefit ratios. Nonetheless, this essay argues in favor of a general regulatory presumption against consumption for the most expensive medical technology usages, which drive most of aggregate healthcare spending. This essay synthesizes twelve facts about the ways in which medical technologies are produced, regulated, studied, and consumed to suggest that it is quite unlikely that the most expensive usages of …

The Tobacco Diaries: Lessons Learned And Applied To Regulation Of Dietary Supplements, Joanna K. Sax

Faculty Scholarship

This Article examines the future role of the FDA in the regulation of the dietary supplement industry. To address the role of the FDA in the twenty-first century with respect to the dietary supplement industry, Part I of this Article begins by describing the dietary supplement industry and the role of the FDA in this industry. In Part II, this Article provides a brief exposé of the tactics used by the tobacco industry to evade regulation. The purpose of Part II is to provide insight into the tobacco industry’s ability to manipulate consumers and discount scientific proof of the harmful …

When Congress Practices Medicine: How Congressional Legislation Of Medical Judgment May Infringe A Fundamental Right, Shannon L. Pedersen

Touro Law Review

No abstract provided.

Enough About The Constitution: How States Can Regulate Health Insurance Under The Aca, Brendan S. Maher, Radha A. Pathak

Faculty Scholarship

Last term, the United States Supreme Court upheld the constitutionality of the Affordable Care Act in a landmark decision. It is a forceful reminder that America’s oldest question — how power should be shared between federal and state sovereigns — retains powerful political salience. Critics have reflexively attacked the decision as an assault on states’ rights, while supporters have celebrated the result. Regrettably, insufficient attention has been paid to how, in actuality, health care regulatory authority has been and will be divided between federal and state governments. In this Article, we fill that gap. To do so, we apply “federalism-in-fact,” …

Ovaries, Testicles, And Uteruses, Oh My! Regulating Reproductive Tissue Transplants, Valarie K. Blake

Scholarly Works

This article will explore key regulatory and ethical challenges presented by reproductive tissue transplants (RTTs) as they are currently developing, recognizing that additional issues may reveal themselves as the technologies progress. Part I of this article will begin with a discussion of the current status of the technology, including the results and status of animal and human experiments for all three types of transplants. Part II will explore the demand for RTTs — who might consider such a transplant and why RTTS might be considered by some patients as more favorable than other reproductive options. Part III will explore the …

Prioritizing Abortion Access Over Abortion Safety In Pennsylvania, Randy Beck

Scholarly Works

This conference was prompted by the prosecution of Dr. Kermit Gosnell, who ran an abortion clinic in Philadelphia, Pennsylvania. Dr. Gosnell was convicted in May of 2013 of charges arising from the killing of viable infants born in his clinic, the negligent death of an adult patient, and the systematic disregard of regulations governing the performance of abortions in Pennsylvania. One question proposed for our consideration is whether Dr. Gosnell is an “outlier,” a description offered by the National Abortion Federation following Gosnell’s indictment.

Presumably, one might want to know whether Gosnell was typical of abortion providers because it could …

Beyond Abortion: Human Genetics And The New Eugenics, John R. Harding Jr.

Pepperdine Law Review

No abstract provided.

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 Fda Sends Smoke Signals To Big Tobacco: Will The Fda Suffer Backlash, Will Alcohol Be Regulated Next, And Will The Health Of Americans Prevail?, Angela Turriciano

Pepperdine Law Review

No abstract provided.

Reducing The Discount Rate, Ben L. Trachtenberg

Faculty Publications

This article presents two arguments against the “discounting” of future human lives as part of cost benefit analysis, or CBA. Our first argument is that because CBA has thus far ignored evidence of rising health care expenditures, it underestimates the “willingness to pay” for health and safety that future citizens will likely exhibit, thereby undervaluing their lives. Our second argument is that until recently CBA has ignored the trend of improved material conditions in developed countries, and most agencies continue to ignore it entirely. As time advances, residents of rich countries tend to live better and spend more, meaning that …

Can Law Improve Prevention And Treatment Of Cancer?, Roger Magnusson, Lawrence O. Gostin, David Studdert

O'Neill Institute Papers

The December 2011 issue of Public Health (the Journal of the Royal Society for Public Health) contains a symposium entitled: Legislate, Regulate, Litigate? Legal approaches to the prevention and treatment of cancer. This symposium explores the possibilities for using law and regulation – both internationally and at the national level – as the policy instrument for preventing and improving the treatment of cancer and other leading non-communicable diseases (NCDs). In this editorial, we argue that there is an urgent need for more legal scholarship on cancer and other leading NCDs, as well as greater dialogue between lawyers, public health practitioners …

Outsourcing Human Reproduction: Embryos & Surrogacy Services In The Cyberprocreation Era, J. Brad Reich, Dawn Swink

Journal of Health Care Law and Policy

No abstract provided.

Meaningful Use And Certification Of Health Information Technology: What About Safety?, Sharona Hoffman, Andy Podgurski

Faculty Publications

Health information technology (HIT) is becoming increasingly prevalent in medical offices and facilities. Like President George W. Bush before him, President Obama announced a plan to computerize all Americans’ medical records by 214. Computerization is certain to transform American health care, but to ensure that its benefits outweigh its risks, the federal government must provide appropriate oversight.

President Obama’s stimulus legislation, the American Recovery and Reinvestment Act of 29 (ARRA), dedicated $27 billion to the promotion of health information technology. It provides payments of up to $44, per clinician under the Medicare incentive program and $63,75 per clinician under the …

Making Health Markets Work Better Through Targeted Doses Of Competition, Regulation, And Collaboration, Len M. Nichols

Saint Louis University Journal of Health Law & Policy

No abstract provided.