Food and Drug Law Commons^™

Encouraging Interagency Collaboration: Learning From Covid-19, Rachel Sachs

Scholarship@WashULaw

In the health innovation context, federal regulatory authority is sharply fragmented among different agencies. The National Institutes of Health, Food and Drug Administration, Centers for Medicare and Medicaid Services, and other agencies all share responsibilities in the development and dissemination of new healthcare technologies. Scholars have previously written about the importance of interagency collaboration both in the healthcare area and more generally, and about strategies for encouraging collaborative efforts to promote various policy goals. Under these accounts, a failure to collaborate between federal agencies may be unfortunate, but it does not typically result in or exacerbate a crisis. In the …

Drugs, Patents, And Well-Being, Christopher Buccafusco, Jonathan S. Masur

Faculty Scholarship

The ultimate end of patent law should be to spur innovations that improve human welfare-innovations that make people better off. But firms will only invest resources in developing patentable inventions that will allow them to make money-that is, inventions that people will want to use and buy. This can gravely distort the types of incentives that firms face and the types of inventions they pursue. Nowhere is this truer than in the pharmaceutical field There is by now substantial evidence that treatments for diseases that primarily afflict poorer people-including the citizens of developing nations-are dramatically underproduced, compared with drugs that …

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 …

The Rhetorical Transformations And Policy Failures Of Prescription Drug Pricing Reform Under The Trump Administration, Rachel Sachs

Scholarship@WashULaw

Throughout his four years in office, President Trump made prescription drug pricing a focus of his policy agenda. President Trump not only used strong language to criticize the pharmaceutical industry and its practices but also introduced ambitious reform policies that had previously lacked acceptance among Republican policy makers. President Trump appears to have been successful in developing a new populist form of rhetoric that Republicans can use in support of novel drug pricing reforms such as the ones his administration considered. From a policy perspective, however, the Trump administration failed to implement any of their more ambitious reform ideas. This …

Neither “Post-War” Nor Post-Pregnancy Paranoia: How America’S War On Drugs Continues To Perpetuate Disparate Incarceration Outcomes For Pregnant, Substance-Involved Offenders, Becca S. Zimmerman

Pitzer Senior Theses

This thesis investigates the unique interactions between pregnancy, substance involvement, and race as they relate to the War on Drugs and the hyper-incarceration of women. Using ordinary least square regression analyses and data from the Bureau of Justice Statistics’ 2016 Survey of Prison Inmates, I examine if (and how) pregnancy status, drug use, race, and their interactions influence two length of incarceration outcomes: sentence length and amount of time spent in jail between arrest and imprisonment. The results collectively indicate that pregnancy decreases length of incarceration outcomes for those offenders who are not substance-involved but not evenhandedly -- benefitting white …

Ignoring Drug Trademarks, Erika Lietzan

Faculty Publications

If you walk into a pharmacy with a prescription for Merck’s ZOCOR, which contains simvastatin, the pharmacist will probably give you a product containing simvastatin made by another company. The pharmacist will dispense a “generic” simvastatin product. State generic substitution laws, passed in the 1970s to help the government save money by switching patients to cheaper generic drugs, either permit or require this substitution. But drug brand names -- such as ZOCOR -- are trademarks. Like other trademarks, they distinguish goods in the market from others, and they signal the source of the goods. These state laws essentially treat the …

Is Germline Gene Editing Exceptional?, Myrisha S. Lewis

Faculty Publications

Advances in gene editing have recently received significant scientific and media attention. Gene editing, especially CRISPR-Cas9, has revived multiple longstanding ethical debates, including debates related to parental autonomy, health disparities, disability perspectives, and racial and economic inequalities. Germline, or heritable, gene editing generates several newer, neglected bioethical debates, including those about the shared human germline and whether there is a "line" that humans should not cross.

This Article addresses several interrelated ethical and legal questions related to germline gene editing. Those questions address why, if at all, germline gene editing needs to be regulated and, if germline gene editing needs …

Innovative Regulatory And Financial Parameters For Advancing Carbon Capture And Storage Technologies, Zen Makuch, Slavina Georgieva & Behdeen Oraee-Mirzamani

Fordham Environmental Law Review

No abstract provided.

Lessons From Renewable Energy Diffusion For Carbon Dioxide Removal Development, Anthony E. Chavez

Fordham Environmental Law Review

No abstract provided.

Regaining Control Over The Climate Change Narrative: How To Stop Right-Wing Populism From Eroding Rule Of Law In The Climate Struggle In India, Binit Agrawal

Fordham Environmental Law Review

No abstract provided.

Textiles As A Source Of Microfiber Pollution And Potential Solutions, Lea M. Elston

Fordham Environmental Law Review

No abstract provided.

Commercializing Cannabis: Confronting The Challenges And Uncertainty Of Trademark And Trade Secret Protection For Cannabis-Related Businesses, John Mixon

Washington Journal of Law, Technology & Arts

Over the last couple of decades, society has become more accepting of recreational cannabis and an ever-growing number of states have passed pro-cannabis legislation. With this change, the cannabis industry has, to some extent, exploded into a booming enterprise in states that have legalized marijuana. Nonetheless, cannabis' status as a Schedule I banned substance under the Controlled Substances Act of 1970 remains unchanged. As a result, businesses in the cannabis industry face the unique challenge of having to toe the line between "legally" operating under state law and violating federal law, which trumps state law. One particular situation in which …

United States Food Law Update: Labeling Contoversies, Biotechnology Litigation, And The Safety Of Imporeted Food, A. Bryan Endres

Journal of Food Law & Policy

This update summarizes significant changes and developments in food law throughout the first half of 2007. Out of necessity, not every change is included; rather, this update is limited to significant changes in national law. This series of updates provides a starting point for scholars, practitioners, food scientists, and policymakers determined to understand the shaping of food law in modern society. Tracing the development of food law through these updates also builds an important historical context for the overall development of the discipline.

Beetles For Breakfast: What The Fda Should Be Telling You, Kaycee L. Wolf

Journal of Food Law & Policy

Imagine sitting down to breakfast and eating strawberry yogurt with a glass of grapefruit juice. You think you are eating a healthy meal, but along with vitamins, calcium, and nutrients, you are getting a side of crushed beetles. Cochineal extract and carmine, two color additives derived from the cochineal beetle, color many foods such as strawberry yogurt. When people consume products with color additives, most do not realize that they could be ingesting insects, which can also be potentially dangerous, not to mention possibly unappetizing or upsetting. Imagine that one minute you are sitting down to eat a healthy cup …

Uncapping The Bottle: A Look Inside The History, Industry, And Regulation Of Bottled Water In The United States, Joyce S. Ahn

Journal of Food Law & Policy

"Agu chupa! Agu chupa!" As we drove through the lush rolling hills of northwestern Rwanda, a crowd of young children appeared from the tea fields and repeatedly shouted these words to us. The taxi driver explained that the children wanted our "water bottes." Aware that visitors often drink bottled water, the children run alongside taxis with the hopes of obtaining the plastic bottles. Although Rwandan children typically carry their drinking water in tightly-woven baskets, the modern plastic bottles have become popular and prized possessions.

The Battle Of The Bulge: Evaluating Law As A Weapon Against Obesity, Margaret Sova Mccabe

Journal of Food Law & Policy

"Silly rabbit, Trix are for kids." Since the 1970s, kids have gotten to know the silly rabbit created to promote sugary, fruit-flavored cereal in television ads. Today, "i'm lovin' it" is the McDonald's slogan, but to millions of children the more recognizable symbol is Ronald McDonald. Ronald McDonald is so recognizable that one study pegged recognition of Ronald among American children at 96% and another at 80% by children in nine other countries. Giventhe "obesity crisis," many question whether these ads should be permitted, with some questioning whether such products are even safe for children's consumption. The Trix Rabbit and …

Contents, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Journal Of Food Law & Policy - Fall 2007, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Caps On Capsules: Prescription For Lower Drug Prices In The United States, Christine Chasse

Student Scholarship

The United States is the foremost innovator of pharmaceutical therapies in the world. That innovation, however, comes at a price—literally. Americans pay more for their medications than any other country. In a country without universal healthcare, the topics of economics, human rights, and healthcare intersect at the crossroads of pharmaceutical pricing. In contrast to most other countries, the United States has no regulations on pharmaceutical price control. One major argument against government regulation is its inherent opposition to the free market system: the heart of the American economy. Further still is the argument that profit restriction would create a chilling …

The Regulation Of Commercial Speech: Can Alternative Meat Companies Have Their Beef And Speak It Too?, Eryn Terry

Vanderbilt Journal of Entertainment & Technology Law

Would you eat a hamburger that was made in a petri dish? Consumers may have this option soon as laboratory-grown meat begins to hit supermarket shelves. Laboratory-grown meat is made from animal stem cells that eventually transform into primitive fibers and tissue within the confines of a petri dish. Although a lot remains unknown about laboratory-grown meat, consumers can think of it as meat production without the farm. How might consumers react to meat labels indicating that their products were made in a petri dish? Laboratory-grown meat companies have yet to find out, as some states have passed laws that …