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Articles 1 - 7 of 7
Full-Text Articles in Food and Drug Law
Current Navigation Points In Drug Diversion Law: Hidden Rocks In Shallow, Murky, Drug-Infested Waters, John J. Mulrooney Ii, Katherine E. Legel
Current Navigation Points In Drug Diversion Law: Hidden Rocks In Shallow, Murky, Drug-Infested Waters, John J. Mulrooney Ii, Katherine E. Legel
Marquette Law Review
None
Pharmaceutical Federalism, Patricia J. Zettler
Pharmaceutical Federalism, Patricia J. Zettler
Indiana Law Journal
There is growing interest in states regulating pharmaceuticals in ways that challenge the U.S. Food and Drug Administration’s (FDA) federal oversight. For example, in 2013, Maine enacted a law to permit the importation of unapproved drugs, reflecting concerns that federal requirements are too restrictive, while in 2014 Massachusetts banned an FDA-approved painkiller, reflecting concerns that federal requirements are too lax. This Article provides an account of this recent state interest in regulating drugs and considers its consequences. It argues that these state regulatory efforts, and the nascent litigation about them, demonstrate that the preemptive reach of the FDA’s authority extends …
Cultivating Innovation In Precision Medicine Through Regulatory Flexibility At The Fda, Jordan Paradise
Cultivating Innovation In Precision Medicine Through Regulatory Flexibility At The Fda, Jordan Paradise
Faculty Publications & Other Works
No abstract provided.
The Statutory Case Against Off-Label Promotion, Nathan Cortez
The Statutory Case Against Off-Label Promotion, Nathan Cortez
Faculty Journal Articles and Book Chapters
The Federal Food, Drug, and Cosmetic Act (FDCA) does not expressly prohibit companies from marketing or promoting drugs for unapproved, off-label uses. The FDA itself acknowledges that off-label promotion is not a prohibited act under the statute, or an element of any such act. Instead, the FDA uses off-label promotion as evidence of other statutory violations. This Article engages in perhaps the most thorough statutory construction analysis of the FDCA on this question, finding that the statute does support the FDA's functional ban on off-label promotion. Using various tools of construction, I find that several sections of the FDCA assume …
Criminal Law—When Apples Tatse Like Oranges, You Cannot Judge A Book By Its Cover: How To Fight Emerging Synthetic "Designer" Drugs Of Abuse, Andrew Payne Norwood
Criminal Law—When Apples Tatse Like Oranges, You Cannot Judge A Book By Its Cover: How To Fight Emerging Synthetic "Designer" Drugs Of Abuse, Andrew Payne Norwood
University of Arkansas at Little Rock Law Review
No abstract provided.
Tax Treatment Of A Marijuana Business, Douglas A. Kahn, Howard Bromberg
Tax Treatment Of A Marijuana Business, Douglas A. Kahn, Howard Bromberg
Articles
Currently, twenty-eight states and the District of Columbia allow the use of marijuana for medical purposes and permit the conduct of a business marketing of marijuana for that purpose. Eight of those states and the District of Columbia permit the recreational use of marijuana. There is reason to believe that more states will decriminalize the marketing of marijuana. However, marijuana is listed in Schedule 1 of the federal Controlled Substances Act of 1970 (CSA) which makes it illegal under federal law to manufacture or distribute marijuana even when it is legal to do so under local state law. In a …
12 Angry Men V. The Agency: Why Preemption Should Resolve This Conflict In Drug Labeling Litigation, Michelle L. Richards
12 Angry Men V. The Agency: Why Preemption Should Resolve This Conflict In Drug Labeling Litigation, Michelle L. Richards
Marquette Law Review
The Supreme Court has found in favor of preemption in tort liability cases involving matters of heavy federal regulation in which Congress has delegated implementation of a statute involving technical subject matter to the agency. It has not been the case, however, in matters concerning the labeling of prescription drugs, despite the fact that the FDA has exclusively regulated drug labeling for more than a century. In fact, the current state of affairs now allows a jury to substitute the judgment of the FDA in approving a label on a name-brand drug for their own in state law failure to …