Emory Law Journal

Volume 60Issue 3

Smoking Out Big Tobacco: Can the Family Smoking Prevention and Tobacco Control Act Equip the FDA to Regulate Tobacco Without Infringing on the First Amendment?

Matt Shechtman | 60 Emory L.J. 705 (2010)

Tobacco use is one of the most catastrophic public health issues facing the world today. The recently passed Family Smoking Prevention and Tobacco Control Act (FSPTCA) gives the United States Food and Drug Administration (FDA) unprecedented power to regulate tobacco products. These provisions, however, may unconstitutionally infringe on First Amendment commercial speech under the judicially crafted commercial speech doctrine governed by Central Hudson Gas & Electric Corp. v. Public Service Commission. Indeed, after the FSPTCA’s passage, several tobacco companies filed suit, arguing that these advertising restrictions violate the First Amendment. If these provisions are not modified to fall within the constitutional confines of Central Hudson, the FSPTCA will be nothing more than an impotent piece of legislation, leaving an overworked FDA to pick up the pieces.

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The Doctrine of Equivalents: Fairness and Uncertainty in an Era of Biologic Pharmaceuticals

D. Alan White | 60 Emory L.J. 751 (2010)

Research in the rapidly developing area of biologic pharmaceuticals promises to improve the lives of millions of patients suffering from disorders that were, until very recently, untreatable. The staggering potential market for such treatments has attracted enormous investment from the pharmaceutical industry, with a concomitant increase in related patent disputes. This investment, coupled with proposed legislation that would pave the way for the creation of “follow-on” biologic treatments via a statutory pathway similar to the one created for generic pharmaceuticals by the Hatch–Waxman legislation of the early 1980s, should ensure that the number of patent disputes involving biologic pharmaceuticals will continue to rise dramatically in the coming years.

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