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Articles 1 - 9 of 9
Full-Text Articles in Law
Addiction-Informed Immigration Reform, Rebecca Sharpless
Addiction-Informed Immigration Reform, Rebecca Sharpless
Articles
Immigration law fails to align with the contemporary understanding of substance addiction as a medical condition. The Immigration and Nationality Act regards noncitizens who suffer from drug or alcohol substance use disorder as immoral and undesirable. Addiction is a ground of exclusion and deportation and can prevent the finding of "good moral character" needed for certain immigration applications. Substance use disorder can lead to criminal behavior that lands noncitizens, including lawful permanent residents, in removal proceedings with no defense. The time has come for immigration law to catch up to today's understanding of addiction. The damage done by failing to …
Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg
Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg
Articles
This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of …
Cannabis For Medical Use: Fda And Dea Regulation In The Hall Of Mirrors, Rebecca S. Eisenberg, Deborah B. Leiderman
Cannabis For Medical Use: Fda And Dea Regulation In The Hall Of Mirrors, Rebecca S. Eisenberg, Deborah B. Leiderman
Articles
A majority of Americans now live in states that purport to authorize medical use of cannabis, although federal law continues to prohibit both recreational and medical use. The current legal regime for cannabis is unstable and may be more effective at deterring research than it is at deterring medical use. Lack of data on medical cannabis products poses public health risks as well as policy and legal challenges. Modified regulatory approaches for other kinds of products provide alternative models for encouraging safety and effectiveness research and providing better information about cannabis products already in clinical use.
The Surprising Reach Of Fda Regulation Of Cannabis Even After Rescheduling, Sean M. O'Connor, Erika Lietzan
The Surprising Reach Of Fda Regulation Of Cannabis Even After Rescheduling, Sean M. O'Connor, Erika Lietzan
Articles
As more states legalize cannabis, the push to “deschedule” it from the Controlled Substances Act is gaining momentum. At the same time, the Food and Drug Administration (FDA) recently approved the first conventional drug containing a cannabinoid derived from cannabis—cannabidiol (CBD) for two rare seizure disorders. This would all seem to bode well for proponents of full federal legalization of medical cannabis. But some traditional providers are wary of drug companies pulling medical cannabis into the regular small molecule drug development system. The FDA’s focus on precise analytical characterization and on individual active and inactive ingredients may be fundamentally inconsistent …
The Orphan Drug Act At 35: Observations And An Outlook For The Twenty-First Century, Nicholas Bagley, Benjamin Berger, Amitabh Chandra, Craig Garthwaite
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 …
Contraceptive Equity: Curing The Sex Discrimination In The Aca's Mandate, Greer Donley
Contraceptive Equity: Curing The Sex Discrimination In The Aca's Mandate, Greer Donley
Articles
Birth control is typically viewed as a woman’s problem despite the fact that men and women are equally capable of using contraception. The Affordable Care Act’s contraceptive mandate (Mandate), which requires insurers to cover all female methods of birth control without cost, promotes this assumption and reinforces contraceptive inequity between the sexes. By excluding men, the Mandate burdens women in four ways: it fails to financially support a quarter to a third of women that rely on male birth control to prevent pregnancy; it incentivizes women to endure the risks and side effects of birth control when safer options exist …
Regulation Of Encapsulated Placenta, Greer Donley
Regulation Of Encapsulated Placenta, Greer Donley
Articles
The practice of placenta encapsulation is rapidly growing. It typically involves post-partum mothers consuming their placentas as pills in the months after childbirth. The perceived benefits include improved mood and energy, reduced bleeding and pain, and greater milk supply. But these effects are unproven, and consumption comes with health risks. The rise of this trend has sparked a vigorous debate in the recent medical literature, but this Article is the first to consider the legal implications of placenta encapsulation. This Article examines whether FDA should regulate encapsulated placenta, and if so, whether it should be regulated as a drug, supplement, …
The Critical Tax Project, Feminist Theory, And Rewriting Judicial Opinions, Anthony C. Infanti, Bridget J. Crawford
The Critical Tax Project, Feminist Theory, And Rewriting Judicial Opinions, Anthony C. Infanti, Bridget J. Crawford
Articles
In this essay, the authors discuss the intellectual foundations for their co-edited book, Feminist Judgments: Rewritten Tax Opinions (2017), the first in a series of subject-matter specific volumes published in the U.S. Feminist Judgments Series by Cambridge University Press. Using only the facts and precedents in existence at the time of the original opinion, the contributors to this and other feminist judgments projects around the globe seek to show how application of feminist perspectives could impact, or even change, the holding or reasoning of judicial decisions. Underlying Feminist Judgments: Rewritten Tax Opinions is the belief that the study of taxation …
Commercial Speech Protection As Consumer Protection, Felix T. Wu
Commercial Speech Protection As Consumer Protection, Felix T. Wu
Articles
The Supreme Court has long said that “the extension of First Amendment protection to commercial speech is justified principally by the value to consumers of the information such speech provides.” In other words, consumers—the recipients or listeners of commercial speech—are the ones the doctrine is meant to protect. In previous work, I explored the implications of taking this view seriously in three contexts: compelled speech, speech among commercial entities, and unwanted marketing. In each of those contexts, adopting a listener-oriented approach leads to the conclusion that many forms of commercial speech regulation should receive far less First Amendment scrutiny than …