Law Commons^™

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 …

The Implementation Of Fda Determinations In Litigation - Why Do We Defer To The Pto But Not To The Fda?, William G. Childs

Faculty Scholarship

This Article examines the possible inequity of the treatment of licensees' rights in tort litigation in comparison to patent rights in patent litigation. In particular, this Article presents the presumptions afforded from issued patents as a valid model for the proper treatment of FDA approval in litigation. Presently, most academic discussion proposes either preclusion of tort claims or leaving the system more or less as it stands. This Article, on the other hand, proposes a middle ground.

This Article begins by examining the differences between the USPTO and the FDA. In particular, the quantity and quality of the review provided …

Constitutional Qualms Concerning: Government Restrictions On Tobacco Product Advertising, Barbara A. Noah

Faculty Scholarship

This Article evaluates the constitutionality of a representative series of congressional proposals to limit tobacco advertising. Federal legislation codifying the tobacco settlement included possible restrictions on outdoor advertising, a prohibition on the use of cartoon images, permitting only tombstone format for advertisements in publications that target a youth audience, a prohibition on the sale or gift of promotional items bearing tobacco product names or logos, a ban on industry sponsorship of sporting and other cultural events, and restrictions on Internet promotions. The Author suggests that upon seeking to prevent tobacco companies from encouraging illegal tobacco use by minors, the FDA's …

Nicotine Withdrawal: Assessing The Fda's Effort To Regulate Tobacco Products, Lars Noah, Barbara A. Noah

Faculty Scholarship

At a press conference held on August 23, 1996, just one year after initially revealing his plans, President Clinton announced sweeping federal regulations to combat the underage use of tobacco products. The Food and Drug Administration (FDA) subsequently published a lengthy preamble to accompany the final regulations, detailing the Agency's assessment of the problem and responding to numerous public comments to its notice of proposed rulemaking (NPRM). Characterizing the growing use of tobacco products as a "pediatric disease," FDA Commissioner David Kessler previously had vowed to alter the smoking habits of the newest generation of tobacco users in order to …