Law Commons^™

Food And Drug Regulation: Statutory And Regulatory Supplement (2023), Adam I. Muchmore

Journal Articles

This Statutory and Regulatory Supplement is intended for use with its companion casebook, Food and Drug Regulation: A Statutory Approach (2021). This is not a traditional statutory supplement. Instead, it contains selected, aggressively edited provisions of the Federal Food, Drug and Cosmetic Act (FFDCA), related statutes, and the Code of Federal Regulations. The Supplement includes all provisions assigned as reading in the casebook, as well as a few additional provisions that some professors may wish to cover. The excerpts are designed to be teachable rather than

Marketing Authorization At The Fda: Paradigms And Alternatives, Adam I. Muchmore

Journal Articles

In many critical industries, the Food and Drug Administration’s (FDA’s) marketing authorization decisions determine the range of products available in the United States. Because of the broad scope of the FDA’s marketing authorization responsibilities, the existing scholarship focuses on individual product categories, or small groups of product categories, regulated by the agency. This Article identifies how the existing literature has overlooked important connections between the FDA’s different marketing authorization programs. These connections suggest both explanations for existing programs and strategies for potential reforms.

The Article sets forth a two-level framework for analyzing the FDA’s marketing authorization role. At the first …

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

Faculty Publications

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 …

Encouraging Maternal Sacrifice: How Regulations Governing The Consumption Of Pharmaceuticals During Pregnancy Prioritize Fetal Safety Over Maternal Health And Autonomy, Greer Donley

Articles

Pregnant women are routinely faced with the stressful decision of whether to consume needed medications during their pregnancies. Because the risks associated with pharmaceutical drug consumption during pregnancy are largely unknown, pregnant women both inadvertently consume dangerous medications and avoid needed drugs. Both outcomes are harmful to pregnant women and their fetuses. This unparalleled lack of drug safety information is a result of ill-conceived, paternalistic regulations in two areas of the law: regulations governing ethical research in human subjects and regulations that dictate the required labels on drugs. The former categorizes pregnant women as “vulnerable” and thus precludes them from …

The Inclusion Of Pregnant Women In Clinical Research, Barbara A. Noah

Faculty Scholarship

In the past three decades, there has been unprecedented growth in medical research utilizing human subjects, with much promise for new treatments that extend life, improve quality of life, and prevent disease and disability. Safe prescribing of drug therapies requires that researchers design clinical trials to test products for the benefit of all persons who are likely to utilize them, not just a limited population. For this reason, it is essential that clinical trials include women, pregnant women, children, and racial minorities, as appropriate, because these populations sometimes exhibit different patterns of response or adverse reactions.

Despite some significant progress …

A System Of Men And Not Of Laws: What Due Process Tells Us About The Deficiencies In Institutional Review Boards, Greer Donley

Articles

Governmental regulation of human subjects research involves unique agency action. It delegates power to non-expert committees, Institutional Review Boards, to decide whether research protocols are "ethical" according to vague federal regulations. Without IRB approval, the protocol cannot be investigated. The empirical evidence regarding this system demonstrates that IRBs render deeply inconsistent and inaccurate outcomes. This Article argues that the lack of due process in the IRB system is to blame for such arbitrary agency action. By juxtaposing the levels of process required for IRB approval or research with FDA new drug approval--agency action involving similar interests--this Article highlights that IRBs …

Technology Unbound: Will Funded Libertarianism Dominate The Future?, Steven Goldberg

Georgetown Law Faculty Publications and Other Works

The panel decision in Abigail Alliance, which found a constitutional right to use certain medicines that have not received Food and Drug Administration approval, may not survive further review, but it already stands as an important signpost on the road to further deregulation of the drug market. This trend mirrors the evolution of the in vitro fertilization (IVF) industry which is remarkably unregulated although it raises numerous ethical and consumer protection issues. These developments share an obvious libertarian underpinning, but in both cases it is an odd sort of libertarianism, because proponents of unmediated access to drugs and IVF also …

Does The Fda Have Authority To Regulate Human Cloning?, Elizabeth Price Foley, Elizabeth C. Price

Faculty Publications

Examines the FDA's statutory authority to regulate human cloning.

Anatomy Of A Regulatory Program: Comment On 'Strategic Regulators And The Choice Of Rulemaking Procedures', Jeffrey Lubbers

Articles in Law Reviews & Other Academic Journals

Besides being a very interesting, cogent, and even a tidy study, "Strategic Regulators" sheds some bright light on agency behavior and on the important issue of whether agency rulemaking may be "ossifying."

The study design employed by Hamilton and Schroeder is attractively simple. They started with all of the Environmental Protection Agency's ("EPA's") hazardous waste regulations under the Resource Conservation and Recovery Act ("RCRA") appearing in the Code of Federal Regulations ("CFR"), counting each decimal point CFR number as a separate rule. This yielded 697 rules. They then examined all EPA/RCRA guidance documents issued since the inception of the program …

The Formulation And Review Of Regulations Under The Food, Drug, And Cosmetic Act, Ralph F. Fuchs

Articles by Maurer Faculty

No abstract provided.