Food and Drug Law Commons^™

Please Consult Your Lawyer Before Taking Sorrell: How The Fda Should Approach Social Media For Prescription Drug Advertising, Steven Valentino

Upper Level Writing Requirement Research Papers

No abstract provided.

Trademark Enforcement And Statutory Incentives, Leah Chan Grinvald

Cardozo Arts & Entertainment Law Journal

The combination of the recent U.S. Supreme Court case, Romag Fasteners v. Fossil Group, Inc., and the diamond anniversary of the Lanham Act provides good grounds to reflect on how trademark enforcement and statutory incentives have evolved through the years. Although enforcement of one's trademarks through the use of the courts can be traced back to England in the 1790s, trademark litigation and other enforcement activities have exploded, in relative terms, since the enactment of the Lanham Act in 1946. Although not subject to an easy empirical correlation, this trend suggests that the statute has had an impact on increasing …

Potus And Pot: Why The President Could Not Legalize Marijuana Through Executive Action, Robert A. Mikos

Vanderbilt Law School Faculty Publications

Could the President legalize marijuana, without waiting for Congress to act? The 2020 Presidential Election showed that this question is far from hypothetical. Seeking to capitalize on frustration with the slow pace of federal legislative reform, several presidential candidates promised they would bypass the logjam in Congress and legalize marijuana through executive action instead.

This Essay warns that such promises are both misguided and dangerous because they ignore statutory and constitutional constraints on the President’s authority to effect legal change. It explains why supporters of marijuana reform should be wary of legalizing the drug through executive action, even if that …

Interstate Commerce In Cannabis, Robert A. Mikos

Vanderbilt Law School Faculty Publications

By the end of 2020, more than thirty states had legalized cannabis containing tetrahydrocannabinol ("THC") for at least some purposes.' Each of these states has authorized firms to produce and sell cannabis within its borders. In 2019, those state-licensed firms did a brisk business, selling more than $13 billion worth of cannabis.

However, none of that $13 billion of cannabis is now being sold (legally) across state lines. Instead, each legalization state now has its own, hermetically sealed local cannabis market, supplied entirely by cannabis cultivated and processed inside the state. For example, the $1.75 billion worth of cannabis that …

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 …

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 …

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 …

Gangmastering Passata: Multi-Territoriality Of The Food System And The Legal Construction Of Cheap Labor Behind The Globalized Italian Tomato, Dr. Tomaso Ferrando

FIU Law Review

No abstract provided.

The Making Of An Iconic Cheese: Mozzarella Di Bufala Campana D.O.P., Michele Graziadei

FIU Law Review

No abstract provided.

The Dormant Monster: Florida’S Intrastate Marijuana Regulation And Its Susceptibility To Dormant Commerce Clause Challenge, Ivan Feris, Jr.

FIU Law Review

No abstract provided.

Contract Law In The Agri-Food Supply Chain, Bianca Gardella Tedeschi

FIU Law Review

No abstract provided.

Italian Coffee: Retelling The Story, Helena Alviar García

FIU Law Review

No abstract provided.

Narratives Of Quality In European Food Governance And Beyond, Lorenzo Bairati

FIU Law Review

No abstract provided.

It’S All About The Pasta: Protectionism, Liberalization, And The Challenge For Quality And Sustainability Of Made In Italy, Fernanda G. Nicola, Gino Scaccia

FIU Law Review

No abstract provided.

Credit Supports For Italian Specialty Products: The Case Of Prosciutto And Long-Aged Cheese, Jorge L. Esquirol

FIU Law Review

No abstract provided.

Like Oil Floating On Water: Italy’S Olive Crisis And The Politics Of Backlash Against Transnational Legal Orders, Tommaso Pavone

FIU Law Review

No abstract provided.

Modernizing U.S. Tax Code Section 280e: How An Outdated “War On Drugs” Tax Law Is Failing The United States Legal Cannabis Industry And What Congress Can Do To Fix It, David Butter

FIU Law Review

No abstract provided.

Tobacco Reborn: The Rise Of E-Cigarettes And Regulatory Approaches, Daniel G. Aaron

Lewis & Clark Law Review

This Article examines e-cigarettes, FDA-regulated products which heat nicotine-containing fluid into an aerosol to be breathed into the lungs. Recent data show that e-cigarettes are used by about one-fifth of U.S. high school students. Given that we have, in the Surgeon General’s words, reached an epidemic of youth e-cigarette use, it is worth asking how a product within FDA jurisdiction became a serious threat to 3.6 million youth.

This Article reviews the law surrounding e-cigarettes and the history of FDA’s attempts to regulate them. Administrative law doctrines instruct us that increased presidential control will rein in misbehaving agencies by allowing …

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 …