Volume 62 Issue 1
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Table of Contents
> Inconsistent Government Policies: Why FDA Off-Label Regulations Cannot Survive First Amendment Review under Greater New Orleans
by Ralph F. Hall, a Visiting Associate Professor of Law at the University of Minnesota Law School, Counsel to Baker & Daniels LLP, Indianapolis, IN and Washington, DC and CEO with MR3 Medical, LLC
and
Elizabeth S. Sobotka, a 2007 J.D. Candidate at the University of Minnesota Law School . She received her M.S. in 1989 from the University of Wisconsin-Milwaukee and her B.A. in 1984 from the University of Wisconsin-Madison.
> Issues in the Interpretation of 180-Day Exclusivity
by Erika Lietzan, Partner in the law firm of Covington & Burling LLP, Washington , DC . The views expressed in this article are her own
and
David E. Korn, Assistant General Counsel with the Pharmaceutical Research and Manufacturers of America (PhRMA), Washington , DC . The opinions expressed are his own
> Potential Pathways for Abbreviated Approval of Genetic Biologics under Existing Law and Proposed Reforms in the Law
by Tam Q. Dinh, Associate with Foley and Lardner , Washington , DC. He received a Ph.D. in organic chemistry from UCLA and a J.D. from the University of Virginia Law School. He is the second place winner in the 2005-2006 H. Thomas Austern Memorial Writing Awards Competition, long paper. The views expressed are those of the author
> State School Vending Laws: The Need for a Public Health Approach
by Michele Simon, Founder and Director of the Center for Informed Food Choices, Oakland , CA
and
Ellen J. Fried, Adjunct Assistant Clinical Professor, Department of Nutrition, New York University , New York , NY
> A Free Market for Dietary Supplements: Issues Surrounding DSHEA's Exceptions to the Labeling Exemption for Third-Party Literature
by Jeffrey Zigler, Law student at Southern Methodist University Dedman School of Law
> Reading our Lips: The History of Lipstick Regulation in Western Seats of Power
by Sarah E. Schaffer, A 2006 graduate from Harvard Law School . She is the 2005-2006 winner of an Honorable Mention in the H. Thomas Austern Memorial Writing Awards Competition, long paper
> FDA's Regulation of Prescription Drug Labeling: A Role for Implied Preemption
by Leslie C. Kendrick, Received her J.D. from the University of Virginia School of Law in May 2006. She is the first place winner in the 2005-2006 H. Thomas Austern Memorial Writing Awards Competition, short paper.
> Branded Drug Reformulation: The Next Brand vs. Generic Antitrust Battleground
by Guy V. Amoresano, Director, Business & Commercial Litigation with Gibbons P.C., Newark , NJ
Authors: Ralph F. Hall & Elizabeth S. Sobotka
62 Food and Drug Law Journal 1-48 (2007).
This article asserts that FDA off-label regulation cannot survive First Amendment review under Greater New Orleans . The article surveys FDA's regulatory role and details prohibitions on off-label drug promotion. After reviewing the traditional Central Hudson First Amendment analysis of off-label drug promotion, the article discusses a novel approach on this issue, applying the perspective of conflicting government interests in restricting off-label speech and suggesting that FDA off-label speech restrictions would categorically fail judicial review.
Finally, the article offers Congress several policy alternatives, should this new argument prevail in court.
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Issues in the Interpretations of 180-Day Exclusivity
Authors: Erika Lietzan and David E. Korn
62 Food and Drug Law Journal 49-75 (2007).
Congress created 180-day exclusivity for generic drug applicants in the 1984 Hatch-Waxman amendments to the Federal Food, Drug and Cosmetic Act and amended it substantially in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.
This article discusses the original and amended language on 180-day exclusivity, analyzes interpretative issues addressed by FDA and the courts and describes their resolution with respect to both old and new abbreviated drug applications (ANDAs).
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Potential Pathways for Abbreviated Approval of Generic Biologics under Existing Law
and Proposed Reforms to the Law
Authors: Tam Q. Dinh
62 Food and Drug Law Journal 77-137 (2007).
The increasing use of biological products in medical care and their high costs have brought the issue of generic biologics to the fore. While FDA probably has legal authority to abbreviate the premarket approval of generic biologics under the Food, Drug and Cosmetic Act and Public Health Service Act, FDA or, more preferably, Congress should implement two major reforms.
First, the article asserts, all biologics should be regulated as “drugs” under the FDCA. Second, the abbreviated approval processes under FDCA § 505(b)(2) and § 505(j) should be available to all generic biologics that can be shown to be sufficiently similar to previously approved biologics. These reforms would allow FDA to take into account technological advancements in the manufacturing and analysis of many recombinant protein products. As the Hatch-Waxman Act has done with small-molecule drugs, the article postulates, these reforms will promote consumer access to lower-price generic biologics while balancing the competing interests of generic manufacturers and pioneer companies.
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State School Vending Laws: The Need for a Pubic Health Approach
Author: Michele Simon and Ellen J. Fried
62 Food and Drug Law Journal 139-150 (2007).
School nutrition has taken center stage in the national debate over how to reverse rising rates of childhood obesity. State legislative activity, sluggish at first, has quickly intensified in recent years.
However, the article asserts, a closer look at the laws themselves is critical to prevent an exaggerated perception of progress from overshadowing reality. This article reviews several of the state laws that have been enacted thus far, and the compromises that enabled their passage. Much more needs to be done to improve school food. Moreover, the emerging patchwork quilt of laws strongly suggests a need for a more thoughtful public health approach that includes sound legal analysis outside of the realm of political compromise.
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A Free Market for Dietary Supplements: Issues Surrounding DSHEA's Exceptions to the Labeling Exemption for Third-Party Literature
Author: Jeffrey Zigler
62 Food and Drug Law Journal 151-163 (2007).
The dietary supplement industry has been hampered by recent regulations which create exceptions to the exemption from misbranding in labeling that supplements normally enjoy. This article explores the constitutionality of these exceptions, and the potential, upcoming changes in the law affecting dietary supplements.
Certain exceptions to the explicit labeling exemption for dietary supplements under the Dietary Supplement Health and Education Act (DSHEA) are unconstitutional. These provisions, which essentially defuse the Act's explicit labeling exemption for dietary supplements from misbranding in labeling, may not withstand First Amendment scrutiny, based on the “free market” theory recognized in commercial speech, as well as recent trends in Supreme Court opinions.
Specifically, the restrictions placed on manufacturers of dietary supplements under 21 U.S.C. § 343-2(a)(2-4) undermine some of the specific concerns DSHEA was enacted to address, represent an unconstitutional burden on commercial speech under Central Hudson analysis, “swallow the rule” on the labeling exemption as a result of their overly harsh consequences and overbreadth and ultimately are rendered moot by operation of other laws.
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Reading our Lips: The History of Lipstick Regulation in Western Seats of Power
Author: Sarah E. Schaffer
62 Food and Drug Law Journal 165-225 (2007).
This article traces the history of lipstick's social and legal regulation in Western seats of power, beginning in Ur circa 3,500 B.C.
Sliced in this manner, lipstick's history emerges as heavily cyclical across the Egyptian, Grecian, Roman, Western European, English, and American reigns of power. Examining these many eras' informal social and formal legal regulation of lipstick, reveals how the extent and type of lipstick regulation that Western societies put into place has ever been largely determined by lipstick's fluctuating signification concerning wearers' class and gender. That said, however, advancing medical and scientific knowledge has also played a fairly steadily rising role in lipstick's historic regulatory scheme.
Thus, lipstick status laws, which were primarily intended to protect men, long predated laws concerning lipstick safety. Safety laws, in turn, long focused solely on human safety before very recently also branching out into environmental and animal safety. In the future, Western societies should expect to see a continuation of lipstick status regulations, albeit probably informal social ones, as well as increasingly comprehensive lipstick safety regulations regarding a broadening array of human, environmental, and animal well-being issues.
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FDA's Regulation of Prescription Drug Labeling: A Role for Implied Preemption
Author: Leslie C. Kendrick
62 Food and Drug Law Journal 227-247 (2007).
In issuing its recent final rule on the content and format of prescription drug package inserts, the Food & Drug Administration included a preamble asserting the preemptive effect of its regulation of prescription drug labeling on state law claims for failure-to-warn. This statement raises important questions about agency deference and the substantive merits of FDA's position.
This article argues that the preambulary statement warrants neither Auer nor Chevron deference and thus, under Skidmore , must be evaluated for its persuasive power. It then argues that, under Medtronic, Inc. v. Lohr and Geier v. American Honda Motor Co., Inc ., a role exists for implied preemption of risks affirmatively regulated by FDA, though this role is narrower than that advocated in the drug labeling preamble.
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Branded Drug Reformulation: The Next Brand v. Generic Antitrust Battleground
Author: Guy V. Amoresano
62 Food and Drug Law Journal 249-256 (2007).
The Federal Trade Commission is now examining the strategy used by some brand name manufacturers of making changes to the branded product faced with impending competition from generic substitutes.
Recently, the article notes, antitrust cases have been brought against at least two brand drug manufacturers for employing a reformulation strategy to forestall generic competition. This article examines the 2006 ruling by the U.S. District Court for the District of Delaware denying a motion to dismiss one of those cases and discusses the question of whether the antitrust laws are the appropriate vehicle for promoting the public policy goals embodied in state drug product selection laws.
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Authorized Generics: A Prescription for Hatch-Waxman Reform
Author: Thomas Chen
This article won first place in the 2005-2006 H. Thomas Austern Memorial Writing Awards Competition (long papers), and will be published in the Virginia Law Review .
Authorized generics present the latest controversy in the perennial battle between pioneer and generic drug manufacturers. Under these arrangements, a pioneer firm will “authorize” a generic version of its brand-name drug to enter the market during another generic competitor's 180-day exclusivity period. This practice has generated intense debate within the pharmaceutical industry regarding its potential impact on Paragraph IV patent challenges, in addition to the proper operation and intent of the Hatch-Waxman Act. Because of the immense economic and public health consequences at stake, and previous patterns of Hatch-Waxman abuse, the Federal Trade Commission has recently launched an investigation of authorized generics.
This article explores the qualitative nature of pharmaceutical competition, specifically focusing on the interaction between pharmaceutical supply chain economics and consumer behavior. From these observations, the author proposes a theory of competitive harm and concludes that authorized generics are an anticompetitive strategic behavior, which violate the antitrust laws by deterring Paragraph IV entry. The author finds normative support within the Hatch-Waxman and patent law regimes to corroborate his antitrust analysis. Finally, the author recommends potential solutions to the authorized generics controversy, including Hatch-Waxman legislative reform.
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