Food and Drug Law Commons^™

Moral Panic Or Public Health Crisis? Lessons From Drugs And Gambling For “Addictive” Design, Matthew B. Lawrence, Haomin (Kevin) Yan

Seattle University Law Review

Alcohol, automobiles, guns, lottery, loot boxes, meat, music, opioid painkillers, processed foods, prop bets, slot machines, television, tobacco, violent video games. Over the last century each of these has been subject to concerns—some might even say “moral panics”—from parents and policymakers about avoidable harms to kids and adults. In some cases we look back with the benefit of hindsight and dismiss those concerns as naïve or moralistic. In others we look back at them as justified or as having come too late to check an expanding industry before it did unfathomable harm while growing so powerful that it became all …

Revisiting Patent Linkage, John R. Thomas

Georgetown Law Faculty Publications and Other Works

Alfred Engelberg’s article of a quarter-century ago, Special Patent Provisions for Pharmaceuticals: Have They Outlived Their Usefulness?, raised a provocative question that retains currency today. The special provisions that Hatch-Waxman established, and Engelberg addressed, have come to be known as patent linkage. Following the principle of linkage, the Food and Drug Administration (FDA) cannot approve generic drugs for marketing if they would infringe a patent.

Hatch-Waxman’s complex patent provisions aspire towards multiple salutary purposes, including encouraging the prompt availability of generic drugs, improving public notice of pharmaceutical patents, and accelerating dispute resolution proceedings. Congress also attempted to ameliorate perceived …

The Addiction Restriction: Addiction And The Right To Bear Arms, F. Lee Francis

West Virginia Law Review

This Article is the culmination of a yearlong research project, and it is the first to address addiction and drug use in the area of Second Amendment law. I argue that addicts may be disarmed, if they are dangerous. My dangerousness test centers on illicit use and imminent danger. That is, do the facts and circumstances prove that an individual is in fact a danger? To put it another way, disarmament is appropriate when there exists demonstrable evidence that a person poses a significant and imminent risk of causing public injury. This Article develops and expands upon some themes and …

From Streets To Stats: A Statistical Analysis Of The Quantity Of Illegal Narcotics Seized In The United States, Zachary T. Strickland

Tenor of Our Times

This study aims to determine how seven different variables affect the total quantity of illegal narcotics seized. These seven variables include four dichotomous and three continuous variables, each striving to teach readers how they relate to the quantity of narcotics seized across specific states. My goal for this project is to figure out if there is any relationship to help law enforcement fight the war on drugs. With the continuing apparent rise of this war, this study is crucial in determining potential relationships between a state's characteristics and the quantity of illegal narcotics they forcibly take possession of. I further …

Reducing Prescription Drug Prices: How Competition Can Make Medications Affordable For Patients - Testimony Of Rachel E. Sachs, Rachel Sachs

Scholarship@WashULaw

In this testimony, I will explain how existing law both keeps branded drug prices high but has also enabled the development of lower-cost generic and biosimilar competition for branded prescription drugs and biological products. This competition can be used to promote access to affordable prescription drugs, benefiting not only patients but also our public payers. However, I will also explain the ways in which existing legislative and regulatory efforts have not always succeeded in promoting competition and will offer a path forward for this Committee to examine reforms that not only encourage the approval of lower-cost products but also ensure …

Cosmetic Crisis: The Obsolete Regulatory Framework Of The Ever-Evolving Cosmetic Industry, Isabelle M. Carbajales

University of Miami Law Review

Cosmetics only first became regulated after a series of tragic events where users were seriously harmed from the use of cosmetic products. These tragic events prompted legislators to enact the Food, Drug, and Cosmetics Act of 1938. Before then, law makers feared that regulating the cosmetic industry would lower the tone of legislation because they considered the cosmetic industry to be inconsequential. At present, the regulatory system in place to protect vulnerable cosmetic consumers is nearly identical to when it was enacted over eighty-six years ago—even though the cosmetic market looks nothing like it did back then. The consumer base …

Moving Away From Masking Pain: A Need For Modernization In Pain Management, Tori Collins

Mitchell Hamline Law Journal of Public Policy and Practice

No abstract provided.

Solutions Still Searching For A Problem: A Call For Relevant Data To Support "Evergreening" Allegations, Erika Lietzan, Kristina M. L. Acri

Faculty Publications

For years pharmaceutical policymaking discussions have been revolving around allegations of supposed “evergreening” by pharmaceutical companies, and policymakers have considered a range of significant policy reforms — including to antitrust law and drug regulatory law — to address this purported problem. This paper evaluates empirical data offered to substantiate “evergreening” and explains that these data — though mostly accurate — do not support proposed policy changes.

The “evergreening” claim is that by securing additional patents and FDA-related exclusivities after approval of their new drugs, brand drug companies enjoy a period of exclusivity in the market that is longer than the …

High Time For Change: The Legalization Of Marijuana And Its Impact On Warrantless Roadside Motor Vehicle Searches, Molly E. O'Connell

Washington and Lee Law Review Online

The proliferation of marijuana legalization has changed the relationship between driving and marijuana use. While impaired driving remains illegal, marijuana use that does not result in impairment is not a bar to operating a motor vehicle. Scientists have yet to find a reliable way for law enforcement officers to make this distinction. In the marijuana impairment context, there is not a scientifically proven equivalent to the Blood Alcohol Content standard nor are there reliable roadside assessments. This scientific and technological void has problematic consequences for marijuana users that get behind the wheel and find themselves suspected of impaired driving. Without …

The 1994 Federal Crime Bill: An Evaluation Of The Past, Present, And Future Of Its Impact On The Criminal Justice System, Jade R. Philpot

Honors College Theses

The 1994 Violent Crime Control and Law Enforcement Act was signed into law in response to the crack cocaine and crime epidemic of the 1980s. In this thesis I address the major elements of this bill, the racial, financial, and ethical conflicts that arose thereafter, and the reforms that should be implemented today to correct said conflicts.

Blood In The Water: Why The First Step Act Of 2018 Fails Those Sentenced Under The Maritime Drug Law Enforcement Act, Lauren R. Robertson

Washington and Lee Law Review

For some, the open ocean is prison. The Maritime Drug Law Enforcement Act (MDLEA) prohibits individuals from knowingly or intentionally distributing a controlled substance or possessing it with the intent to distribute. Empowered by the MDLEA, the United States Coast Guard arrests and detains foreign nationals hundreds of miles outside of U.S. territorial waters. After months shackled to Coast Guard ships, these individuals face the harsh reality of American mandatory minimum drug sentencing, judged by the kilograms of drugs on their vessels. But the MDLEA conflates kilograms with culpability. More often than not, those sentenced are fishermen-turned-smugglers due to financial …

Researching Marijuana Law, Seth Quidachay-Swan

Law Librarian Scholarship

This article provides a brief overview of the current legal framework governing the regulation of marijuana at the federal and state levels in the United States. It also provides an overview of the state of Michigan’s current regulatory framework and resources for attorneys interested in learning more about marijuana regulation.

Fair Lending For Cannabis Banking Justice, Benjamin T. Seymour

University of Michigan Journal of Law Reform Caveat

This Comment offers a fair lending solution to promote racial equity in cannabis banking reform: amend the Equal Credit Opportunity Act to ensure individuals previously arrested, charged, or convicted for selling, cultivating, or possessing marijuana will not therefore be precluded from loans to start legal cannabis businesses. Given disparities in the criminal enforcement of marijuana laws, this amendment would provide racial justice benefits, while also encouraging entrepreneurship. As a market-based social justice effort, this amendment offers a bipartisan approach to one of the most vexing and contentious issues in marijuana banking reform.

Part II of this Comment briefly surveys the …

A Model For Defunding: An Evidence-Based Statute For Behavioral Health Crisis Response, Taleed El-Sabawi, Jennifer J. Carroll

Faculty Publications

Too many Black persons and other persons of color are dying at the hands of law enforcement, leading many to call for the defunding of police. These deaths were directly caused by excessive use of force by police officers, but were also driven by upstream and institutional factors that include structural racism, institutional bias, and a historic culture of racialized violence. Public outcry against racial inequities has increased as the authority of police departments has expanded to include not only the authority to respond to and investigate criminal activity, but also to respond to calls regarding behavioral health issues and …

Recent Trends In Medicaid Spending And Use Of Drugs With Us Food And Drug Administration Accelerated Approval, Rachel Sachs, Kyle A. Gavulic, Julie M. Donohue, Stacie B. Dusestzina

Scholarship@WashULaw

State Medicaid programs have reported concerns about rising drug prices and spending, particularly regarding drugs entering the market through the accelerated approval program under the US Food and Drug Administration (FDA). The accelerated approval program enables the FDA to approve drugs on the basis of unverified surrogate end points, meaning that clinical benefits for these products are uncertain at the time of approval. However, state Medicaid programs are legally required to cover these drugs. Little is known about the set of products with accelerated approval over time, their use among Medicaid beneficiaries, or the magnitude of their financial influence on …

Importing Prescription Drugs From Canada — Legal And Practical Problems With The Trump Administration's Proposal, Rachel E. Sachs, Nicholas Bagley

Articles

As Americans report ever-growing difficulty affording their prescription drugs, President Donald Trump has come under increasing pressure to act. To date, the Trump administration has attempted to advance a number of policy initiatives by means of executive action, but it has not yet adopted a program that would meaningfully assist patients. Most recently, the administration proposed a rule that, if finalized, would allow states to develop programs to import lower-priced prescription drugs from Canada, with the intent of reducing spending on drugs by U.S. patients and states and increasing access for patients.

Response To 'Reverse Al Capone-Ism' And The Tax Treatment Of Marijuana Businesses, Douglas A. Kahn, Howard J. Bromberg

Other Publications

Mr. Silverberg’s comment stresses that the proponents of the legalization of marijuana have not been able to convince Congress to legalize it, and so it is appropriate for Congress to penalize trafficking in that drug. Apparently, he sees our contention that the penalty adopted in I.R.C. § 280E is irrational and contravenes established punitive jurisprudence as a backdoor attempt to accomplish indirectly, by weakening the penalties on the marijuana businesses, what has not been able to be accomplished by those seeking its federal legalization. That was not the motive for our proposal and is not a fair reading of our …

Response To Dude, Where's My Deduction?, Douglas A. Kahn, Howard J. Bromberg

Other Publications

Mr. Pullin’s thesis is that marijuana should be excluded from § 280E when it is operated legally under state law. However, his preferred solution is that the federal government remove marijuana from Schedules I and II of the Controlled Substances Act of 1970 (CSA), thereby legalizing it for federal law purposes. Either action would exclude the marijuana business from § 280E.

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

Indiana Law Journal

Is more information always better? First Amendment commercial speech jurisprudence takes this as a given. However, when information is only available from a self-interested and marketing-savvy pharmaceutical company, more information may simply lead to more misinformation. Notably, doctors are also misled. This can result in public health harms when companies are promoting unapproved uses of prescription drugs that the Food and Drug Administration (FDA) has approved for other purposes—commonly referred to as “off-label” uses. Contrary to judicial presumptions, as well as the presumptions of some doctors and scholars, doctors are not sophisticated enough to always discern what is true versus …

The "Evergreening" Metaphor In Intellectual Property Scholarship, Erika Lietzan

Faculty Publications

This article is a plea for changes in the scholarly dialogue about "evergreening" by drug companies. Allegations that drug companies engage in "evergreening" are pervasive in legal scholarship, economic scholarship, medical and health policy scholarship, and policy writing, and they have prompted significant policymaking proposals. This Article was motivated by concern that the metaphor has not been fully explained and that policymaking in response might therefore be premature. It canvasses and assesses the scholarly literature-more than 300 articles discussing or mentioning "evergreening." It catalogues the definitions, the examples, and the empirical studies. Scholars use the term when describing certain actions …

A Higher Authority: Canada’S Cannabis Legalization In The Context Of International Law, Antonia Eliason, Robert Howse

Michigan Journal of International Law

Part I of this Article provides an overview of some of the key terms and provisions of Canada’s Cannabis Act. Part II looks at the Cannabis Act in the context of the International Drug Conventions, examining how the various convention provisions might apply, looking first at the Single Convention and then at the 1988 Convention and how that convention fits with Canadian constitutional provisions. Part III focuses on the international human rights framework and how the Cannabis Act might be viewed as compatible with international human rights law even where incompatible with the International Drug Conventions. This Part also offers …

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 …

Acting Differently: How Science On The Social Brain Can Inform Antidiscrimination Law, Susan Carle

Scholarly Articles in Law Reviews & Journals

Legal scholars are becoming increasingly interested in how the literature on implicit bias helps explain illegal discrimination. However, these scholars have not yet mined all of the insights that science on the social brain can offer antidiscrimination law. That science, which researchers refer to as social neuroscience, involves a broadly interdisciplinary approach anchored in experimental natural science methodologies. Social neuroscience shows that the brain tends to evaluate others by distinguishing between "us" versus "them" on the basis of often insignificant characteristics, such as how people dress, sing, joke, or otherwise behave. Subtle behavioral markers signal social identity and group membership, …

The Pharma Barons: Corporate Law's Dangerous New Race To The Bottom In The Pharmaceutical Industry, Eugene Mccarthy

Michigan Business & Entrepreneurial Law Review

In this Article, I argue that drug companies have created a highly profitable but dangerous business model by employing the same legal tactics as the nineteenth-century “robber barons,” the group of financiers who orchestrated corporate law’s infamous race to the bottom. Like these historical financiers, drug company executives have captured the legal apparatus and regulatory bodies that oversee them. In so doing, they have transformed the law from a system of governance into a set of enabling doctrines. The pharmaceutical industry has turned legislation intended to protect the public into a legal justification for marketing ineffective and unsafe prescription drugs. …

Paper Promises For Drug Innovation, Erika Lietzan

Faculty Publications

Innovation does not stop when a new medicine is launched. Development of new uses for already approved drugs, in particular, can make profound contributions to the public health. Whether a new use is suspected during the initial premarket trials, identified through focused research after approval, or discovered serendipitously by physicians treating patients, however, it requires extensive clinical testing before it can be approved by FDA. This testing takes time and money — three to five years on average, and as much as $300 million. This Article considers the incentives that federal law offers to companies to make this investment: patent …

Limiting State Flexibility In Drug Pricing, Nicholas Bagley, Rachel E. Sachs

Articles

Throughout the United States, escalating drug prices are putting immense pressure on state budgets. Several states are looking for ways to push back. Last year, Massachusetts asked the Trump administration for a waiver that would, among other things, allow its Medicaid program to decline to cover costly drugs for which there is limited or inadequate evidence of clinical efficacy. By credibly threatening to exclude such drugs from coverage, Massachusetts hoped to extract price concessions and constrain the fastest-growing part of its Medicaid budget.

Drug Approval In A Learning Health System, W. Nicholson Price

Articles

The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA—and the health system generally—should gather information after drugs are approved to learn how well they work and how safe they are. This is hard to do. FDA has its own surveillance systems, but those systems face substantial limitations in practical use. Drug companies can also conduct their own studies, but have little incentive to do so, and often fail to fulfil study commitments made to FDA. Proposals to improve this dynamic often suggest gathering more …

Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox

Michigan Telecommunications & Technology Law Review

Biologic drugs offer major advancements over small-molecule drugs when it comes to treating serious diseases. Biosimilars, which mimic innovative biologic drugs, have the potential to further revolutionize the practice of medicine. States now have decades of experience regulating the substitution of generic, small-molecule drugs for their brand-name equivalents. But the complexities of biologic drugs and biosimilars force states to confront novel scientific and legal issues. Many states have begun tackling those issues by passing laws that regulate when pharmacists may substitute biosimilars for their corresponding biologic drugs. Other states have yet to do so. This Note surveys five provisions common …

Improving Generic Drug Approval At The Fda, Kathleen Craddock

Michigan Journal of Environmental & Administrative Law

Generic drugs are the store-brand cereal of the drug world. While they lack the vibrant colors of and exciting commercials behind name brands, generics are still effective. Most importantly, for some people, they make the difference between accessing essential treatment and going without. Getting generics to market as quickly as possible means fewer people will cut pills in half or skip doses to save money, which also saves billions of dollars across the U.S. health system. Because a new generic does not offer lifesaving changes for people with rare or complicated diseases, generics lack the “cultural capture of rhetoric about …

Update On Fda Regulation Of Mhealth And Wellness Devices, Barbara Zabawa

Faculty Works

This article provides an update on the evolving regulatory landscape of mobile health (mHealth) and wellness devices, focusing on changes introduced by the Food and Drug Administration (FDA) through its 2017 Draft Guidance. These updates aim to clarify inconsistencies in the definitions and regulatory status of various categories of devices, such as mobile medical apps, general mobile apps, and low-risk wellness devices. The Draft Guidance redefines certain wellness devices, emphasizing that those related to chronic diseases or conditions may now be recognized as medical devices but remain under FDA's enforcement discretion if they pose minimal safety risks. Additionally, the article …