Food and Drug Law Commons^™

Cannabis Law, The Constitution, And The Aba Model Rules, Hayley Hollis

Lewis & Clark Law Review

Though a growing number of states have legalized recreational or medical cannabis use, cannabis is still categorized as a Schedule I substance under the Controlled Substances Act, and its use, possession, and cultivation are federal offenses. This conflict between state and federal law creates a unique challenge for the legal community. Unless states with legalized cannabis programs have amended their state rules of professional conduct or provided advisory opinions on the matter, local attorneys assume a great deal of risk when representing clients within the cannabis industry.

To further complicate matters, what happens when a lawyer, who is licensed to …

Redefining "Life": The Constitutional Implications Of Patenting Immortality, Julia Spivak

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Rethinking Consumer Protection: Escaping Death By Regulation, Thomas L. Tacker

Publications

This book is designed to appeal to anyone who is at all interested in topics related to making life better and safer—for all us consumers. Our current approach to consumer protection is extremely flawed; sometimes costing lives rather than saving them. There are better ways to protect ourselves and the people we love.

The Role Of Pressure Groups And Problem Definition In Crafting Legislative Solutions To The Opioid Crisis, Taleed El-Sabawi

Faculty Publications

Organized interest groups and federal administrative agencies have historically been influential in defining problem drug use during nationwide crisis. As such, the manner in which these pressure groups defined the problem may have influenced or, at least, provided support for legislators’ decisions to shy away from a criminal justice approach and towards acceptance of a more “health-oriented” — one that did not comprehensively address demand factors or demonstrate a commitment to reforming U.S. drug policy to meet international standards of best practice. In an effort to provide a snapshot of what such involvement may look like, this article explores the …

"Hash"Ing Out Inequality In The Legal Recreational Cannabis Industry, Maya Rahwanji

Northwestern Journal of International Law & Business

No abstract provided.

The Surprising Reach Of Fda Regulation Of Cannabis Even After Descheduling, Sean M. O'Connor, Erika Lietzan

American University Law Review

No abstract provided.

Ships In The Night: Resolving Administrative Conflict Between Fda- And Patent-Related Legislation, Carlos Garcia, Jonathan Stroud

American University Law Review

No abstract provided.

The Orphan Drug Act At 35: Observations And An Outlook For The Twenty-First Century, Nicholas Bagley, Benjamin Berger, Amitabh Chandra, Craig Garthwaite

Articles

On the thirty-fifth anniversary of the adoption of the Orphan Drug Act (ODA), we describe the enormous changes in the markets for therapies for rare diseases that have emerged over recent decades. The most prominent example is the fact that the profit-maximizing price of new orphan drugs appears to be greater today than it was in 1983. All else equal, this should reduce the threshold for research and development (R&D) investment in an economically viable product. Further, the small size of patient populations for orphan drugs, together with the increasing prevalence of biologics among orphan drugs, have created a set …

Zoning, Race, And Marijuana: The Unintended Consequences Of Proposition 64, Alexis Holmes

Lewis & Clark Law Review

This Article revisits the campaign to legalize cannabis in California with Proposition 64. It then dissects the localism within the new California regulations and how it conflicts with the social justice goals central to the spirit of Proposition 64’s passage. With local governments retaining control over marijuana in their jurisdictions, land use takes on new importance with respect to how marijuana will be controlled. The problem is that the land use system, like the criminal law apparatus, has yet to overcome systemic racism that is inherently part of its design. Proposition 64 wrongly relied on local control to regulate marijuana …

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, …

Life, Liberty, [And The Pursuit Of Happiness]: Medical Marijuana Regulation In Historical Context, Lewis Grossman

Scholarly Articles in Law Reviews & Journals

The struggle for access to medical marijuana differs from most other battles for therapeutic freedom in American history because marijuana also has a popular, though controversial, nontherapeutic use—delivery of a recreational high. After considering struggles over the medical use of alcohol during prohibition as a precedent, this chapter relates the history of medical marijuana use and regulation in the United States. The bulk of the chapter focuses on the medical marijuana movement from the 1970s to present. This campaign has been one of the prime examples of a successful extrajudicial social movement for freedom of therapeutic choice. With the exception …

Greater Uniformity And Centralization: The Regulatory Development Of Chinese Food And Product Safety Under The Wto, Nga Kit (Christy) Tang

Washington International Law Journal

The WTO Agreements emphasize free trade, which links with diversity, deregulation, and decentralization. China, on the other hand, emphasizes uniformity and centralization, especially regarding the political control and the one-party system of “democratic dictatorship.” China’s joining the WTO, therefore, may be considered as a development that changes the regulatory structure to become more diverse, deregulated, and decentralized. This paper, however, finds the opposite. Under the WTO law, China is encouraged to move towards greater uniformity and centralization with its decentralized and non-uniform settings under the market policy. Moreover, the WTO’s uniform and centralized encouragements can be integrated into the rule-by-man …

Federalization's Folly, Stephen F. Smith

Journal Articles

Overcriminalization and overpunishment are the two key features of federal criminal law today, yet the constant drumbeat to “federalize” criminal law has accomplished precious little in terms of public safety. The failed drug war proves as much: federal prosecutors have filled the nation’s prisons with low-level drug dealers and drug users serving long sentences, but drugs remain widely available at greater purity and lower prices throughout the land — and drug overdoses are at record highs. Instead of focusing on areas of federal comparative advantage, such as terrorism, international drug trafficking, and organized crime, federal prosecutors waste scarce resources “playing …

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 …