Law Commons^™

Non-Price Competition In “Substitute" Drugs: The Ftc's Blind Spot, Gregory Dolin

All Faculty Scholarship

As the recent case of United States v. Lundbeck illustrates, the Federal Trade Commission’s lack of knowledge in medical and pharmacological sciences affects its evaluation of transactions between medical and pharmaceutical companies that involve transfers of rights to manufacture or sell drugs, causing the agency to object to such transactions without solid basis for doing so. This article argues that in order to properly define a pharmaceutical market, one must not just consider the condition that competing drugs are meant to treat, but also take into account whether there are “off-label” drugs that are used to treat a relevant condition, …

"Where You Stand Depends On Where You Sit": Should The United States' Fda Have Followed The Lead Of Great Britain's Mhra In Banning Antidepressant Drug Use In Children And Adolescents?, Jennifer Dorminey

Georgia Journal of International & Comparative Law

No abstract provided.

Graphic Labels, Dire Warnings And The Facile Assumption Of Factual Content In Compelled Commercial Speech, Nat Stern

Scholarly Publications

No abstract provided.

E-Cigarettes, Vaping, And Youth, Lawrence O. Gostin, Aliza Y. Glasner

Georgetown Law Faculty Publications and Other Works

E-cigarettes, a relatively new product, storming the tobacco industry are causing a massive stir among public health advocates. While e-cigarettes have the potential to serve as an effective harm reduction tool for existing smokers, they also may present an equally tempting pathway to first time smoking, particularly among youth. Many fear that e-cigarettes will revive the popular smoking culture that has taken decades to dismantle.

In April 2014, the FDA issued proposed rules to “deem” or extend its authority over tobacco products to regulate electronic cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe (hookah) tobacco, and orally ingested dissolvable tobacco products. …

The Continuing Battle Of Fda Regulation Of Dietary Supplements And Their Adverse Affect On Young Adults And Other Individuals, Andrew Bernard Jaffe

Andrew Bernard Jaffe

THE CONTINUING BATTLE OF FDA REGULATION OF DIETARY SUPPLEMENTS AND THEIR ADVERSE AFFECT ON YOUNG ADULTS AND OTHER INDIVIDUALS

Abstract

Ever since the enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA) the Food and Drug Administration (FDA) has struggled to regulate dietary supplements. This is due to the definition of dietary supplements as foods in the act. This gives supplement manufacturers greater loopholes when introducing supplements on the market. The FDA’s inability to regulate dietary supplements efficiently has been present for decades. Multiple battles are still occurring today which is proven to have an adverse effect …

Vape Away: Why A Minimalist Regulatory Structure Is The Best Option For Fda E-Cigarette Regulation, Nick Dantino

University of Richmond Law Review

No abstract provided.

Pharmacy Compounding After The Drug Quality And Security Act, Erika Lietzan

Faculty Publications

On November 27, 2013, President Obama signed into law the Drug Quality and Security Act ("DQSA"), which amends the Federal Food, Drug, and Cosmetic Act ("FDCA") to add statutory provisions addressing drug compounding and supply chain issues. This article discusses Title I of this legislation, known as the Compounding Quality Act, and draft compounding guidances subsequently issued by the Food and Drug Administration ("FDA"). Section I provides a brief history of FDA's regulation of compounding activities before the Compounding Quality Act's enactment. Section II reviews the Compounding Quality Act and FDA's new draft guidances. Section III considers some of the …

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 …

"Natural" Food Labeling: False Advertising And The First Amendment

Marquette Elder's Advisor

No abstract provided.

The Penumbra Of The United States’
 Foreign Corrupt Practices Act: Brazil’S Clean Companies Act And 
Implications For The Pharmaceutical
 Industry, Beverley Earle, Anita Cava

Richmond Journal of Global Law & Business

No abstract provided.

Vape Away: Why A Minimalist Regulatory Structure Is The Best Option For Fda E-Cigarette Regulation, Nick Dantonio

Law Student Publications

This comment argues that the FDA should regulate ecigarettes, but in doing so, it should take a minimalist approach to regulation. Instead of continuing its attempts to regulate tobacco products under the drug and device provisions of the Federal Food, Drug, and Cosmetic Act ("FDCA"), an incredibly stringent statute, the FDA should focus its efforts under the Tobacco Control Act ("TCA"), which is tailored specifically to regulate tobacco products. While the FDA has extensive regulatory options under the TCA, much of this authority should not be applied to ecigarettes. Part II will provide background information on ecigarettes generally as well …

Lighting A Fire Under Free Speech: The Fda's Graphic Attempts To Reduce Smoking Rates, Ashley Peterson

Law Student Publications

This article explores whether a graphic warning is possible or preferable in the government's fight against tobacco. Part II outlines a brief history of tobacco regulation in the United States. Part III turns to the Family Smoking Prevention and Tobacco Control Act (FSPTCA) and the FDA's initial rulemaking process. Part IV outlines the doctrine of commercial free speech, and Part V discusses why the Rule faced insurmountable challenges under this jurisprudence. Part VI explores how the FDA may overcome these hurdles in its future rulemaking, while Part VII discusses alternative methods through which the government can pursue its anti-tobacco agenda …

Dietary Supplement Labeling: Cognitive Biases, Market Manipulation & Consumer Choice, Michael Mccann

Law Faculty Scholarship

There exists increasing concern that the Dietary Supplements Health and Education Act (DSHEA) has proven ineffective. Much of the concern regards the disparity in legislative treatment between dietary supplements, foods, and pharmaceutical drugs. Namely, while pharmaceutical drugs must undergo years of costly pre-market testing, most supplements, like foods, can immediately enter the market, and only after repeated instances of adverse reactions can the Food and Drug Administration (FDA) remove them. Such a framework appears to belie both consumer expectations and marketing strategies, as supplements tend to be most perceived for their apparent medicinal qualities. This philosophy of waiting for a …

Nudging The Fda, W. Nicholson Price Ii, I. Glenn Cohen

Law Faculty Scholarship

[Excerpt] "The FDA’s regulation of drugs is frequently the subject of policy debate, with arguments falling into two camps. On the one hand, a libertarian view of patients and the health care system holds high the value of consumer choice. Patients should get all the information and the drugs they want; the FDA should do what it can to enforce some basic standards but should otherwise get out of the way. On the other hand, a paternalist view values the FDA’s role as an expert agency standing between patients and a set of potentially dangerous drugs and potentially unscrupulous or …

Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii

Law Faculty Scholarship

Despite increasing recalls, contamination events, and shortages, drug companies continue to rely on outdated manufacturing plants and processes. Drug manufacturing’s inefficiency and lack of innovation stand in stark contrast to drug discovery, which is the focus of a calibrated innovation policy that combines patents and FDA regulation. Pharmaceutical manufacturing lags far behind the innovative techniques found in other industries due to high regulatory barriers and ineffective intellectual property incentives. Among other challenges, although manufacturers tend to rely on trade secrecy because of the difficulty in enforcing patents on manufacturing processes, trade secrecy provides limited incentives for innovation. To increase those …

Lighting A Fire Under Free Speech: The Fda's Graphic Attempts To Reduce Smoking Rates, Ashley Peterson

University of Richmond Law Review

No abstract provided.

23andme, The Food And Drug Administration, And The Future Of Genetic Testing, Patricia Zettler, Jacob S. Sherkow, Henry Greely

Other Publications

On November 22, 2013, the US Food and Drug Administration (FDA) effectively halted health-related direct-to-consumer genetic testing in the United States by sending a warning letter to 23andMe, the leading company in the field, directing it to stop providing such testing. The FDA acted as the era of widespread, clinical use of DNA sequencing rapidly approaches. The agency’s action will contribute to changes in which genetic tests are offered to patients and how testing is provided.

Layers Of Law: The Case Of E-Cigarettes, Eric A. Feldman

All Faculty Scholarship

This paper, written for a symposium on "Layers of Law and Social Order," connects the current debate over the regulation of electronic cigarettes with socio-legal scholarship on law, norms, and social control. Although almost every aspect of modern life that is subject to regulation can be seen through the framework ‘layers of law,’ e-cigarettes are distinguished by the rapid emergence of an unusually dense legal and regulatory web. In part, the dense fabric of e-cigarette law and regulation, both within and beyond the US, results from the lack of robust scientific and epidemiological data on the behavioral and health consequences …

Intersection Of Patent Infringement And Antitrust Liability In Abbreviated New Drug Application Litigation, The, Kevin E. Noonan

Journal of Dispute Resolution

A battle has been raging, over the past ten years, regarding the competing interests of patent protection and antitrust prohibitions in the specialized area of law concerned with patented drugs regulated by the Food and Drug Administration ("FDA").' The contestants are the Federal Trade Commission ("FTC") and parties to Abbreviated New Drug Application (ANDA) litigation, which are a branded drug company and a generic challenger.

The Need To Reform In Pharmaceutical Protection: The Inapplicability Of The Patent System To The Pharmaceutical Industry And The Recommendation Of A Shift Towards Regulatory Exclusivities, Amanda Fachler

Fordham Intellectual Property, Media and Entertainment Law Journal

No abstract provided.