FDLI's H. Thomas Austern Memorial
Writing Competitions
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The Competitions Prizes Who is Eligible Paper Requirements Illustrative Topic Areas Topics Judges H. Thomas Austern Available Download: |
•• View Winners of FDLI's 2009 H. Thomas Austern Memorial
Writing Competitions
The Competitions
The Food and Drug Law Institute (FDLI) sponsors the Writing Competitions to encourage law students interested in the areas of law that affect foods, drugs, devices, cosmetics, and biologics. Winning papers will be considered for publication in the Food and Drug Law Journal. There are two competitions—one for papers with a maximum of 40 pages, and one for papers between 41 and 100 pages. Papers longer than 100 pages will not be accepted.
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Prizes
(Two prizes will be awarded for each of the two competitions).*
1st place — $4,000
2nd place — $1,000
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Who is Eligible
Entrants must be currently enrolled in a J.D. program at any of the nation's law schools.
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Paper Requirements
Submissions shall be typewritten, double-spaced on 8½ x 11 inch paper. FDLI will accept electronic submissions as e-mail attachments; these must be WORD® documents, printouts
of which should conform to all other paper requirements. Papers for the short paper competition shall not exceed 40 pages in length, including appendices (if any) and footnotes, which may be single-spaced. Submissions of papers greater than 40 pages automatically
will be entered in the competition for long papers; the maximum number of pages for the longer-paper competition is 100 pages. Papers shall include footnotes, not endnotes. Text and footnote type shall be in 12-pt. Times Roman font. Papers shall have one-inch margins (right, left, top, and bottom). Noncompliance with these requirements will affect evaluation and may result in disqualification. Please include the following information on the cover
sheet of the paper:
- Entrant’s full name, address (mail and e-mail), and telephone number(s)
- Name of law school and year of study
- Date of submission of paper
- Do not include personal identifiers in the paper itself
Papers must be received no later than June 11, 2010.
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Illustrative Topic Areas
The Food and Drug Law Institute is pleased to announce the winners
of the 2009 H. Thomas Austern Memorial Writing Competition.
Short Paper Competition (< 40 pages)
First Place ($4,000) ― April Farris, Harvard School of Law
The “Natural” Aversion: The FDA’s Reluctance to Define a Leading Food-Industry
Marketing Claim, and the Pressing Need for a Workable Rule
Abstract:
As of 2009, the “natural foods” industry has become a 22.3 billion dollar giant and “all-natural” is the second-leading marketing claim for all new food products. Even in such a flourishing market, the Food and Drug Administration (FDA) has never defined the term “natural” through rule-making. FDA and the U.S. Department of Agriculture (USDA) have instead created separate, non-identical policy statements governing the use of the term “natural,” and FDA has abandoned efforts to define “natural” through rule-making in the face of more pressing priorities. To prevent a potential patchwork of definitions varying by state, and to create a legitimate standard resting on informed scientific expertise rather than consumer whims, FDA should engage in rule-making to define the term “natural.” This paper concludes by sketching potential formulations for such a rule based on FDA’s previous successful rule-making ventures and standards used by natural foods retailers.
Second Place ($1,000) ― Nitin Shah, University of Virginia School of Law
When Injury Is Unavoidable: the Vaccine Act’s Limited Preemption of Design Defect Claims
Abstract:
Courts are divided as to whether the National Childhood Vaccine Injury Act of 1986 (NCCIA) preempts all design defect claims involving covered vaccines, or merely requires the injury to have been unavoidable for liability to attach. This paper argues that courts should adopt a reading of the NCCIA which preempts design defect claims only upon a concomitant finding that the injury could not have been avoided, for example, through use of a safer feasible alternate design. It proposes an interpretation of the Supreme Court’s express preemption jurisprudence that focuses on the Court’s application of the plain meaning doctrine and the presumption against preemption. The paper argues that the Court has increasingly applied these doctrines to implement a rule-based approach that allows greater ex ante reliance on the meaning that the Court will give to express preemption clauses.
Honorable Mention ― Julia Kobick ― Harvard Law School
Negotiated Rulemaking: The Next Step in Regulatory Innovation
at the Food and Drug Administration?
Abstract:
Negotiated rulemaking is a regulatory tool designed to build consensus on regulations before notice and comment rulemaking procedures. An agency convenes a negotiation with relevant stakeholders to work together to develop a draft rule. In theory, consensus on a draft rule should then in turn decrease the agency’s workload during the notice and comment period and decrease the likelihood of subsequent litigation challenging the rule. This paper examines instances where FDA has been urged to hold negotiated rulemaking sessions, and then analyzes why FDA has avoided negotiated rulemaking to date. The paper then highlights reasons why FDA might consider using negotiated rulemaking for appropriate regulations.
Long Paper Competition (> 40 pages)
First Place ($4,000) ― Jason M. Szanyi ― Harvard Law School
Brain Food: Bringing Psychological Insights to Bear on Modern Nutrition Labeling Efforts
Abstract:
Food and drug law presents legislators and policy makers with a powerful tool to inform individual dietary decisions and improve public health: mandatory nutritional labeling.
Most Americans report that they consult nutritional information when making food purchases; yet, knowing whether individuals report consulting nutritional information is different than knowing how they actually process and utilize that information. This article argues that psychological research can answer that question. It does so by explaining well-established psychological findings that have the greatest potential application to food labeling efforts. By doing so, this paper aims to help government regulators and private businesses develop more targeted and effective labeling initiatives.
Second Place ($1,000) ― Joan R. Rothenberg ― George Mason University School of Law
In Search of the Silver: Bullet Regulatory Models to Address Childhood Obesity
Abstract:
The concern over obesity today has evolved beyond an issue of personal vanity to a serious national health issue affecting millions of Americans. Obesity in children is especially alarming. This paper examines the history and factors involved in the childhood obesity epidemic, explores regulatory options for its resolution, and provides an overview of obesity as a serious challenge to public health, and the health of children in particular. The federal agencies who share the responsibility for regulating food in the United States and their efforts to address the obesity problem are discussed as a background to various state and federal regulatory models influencing dietary choices. The effectiveness of proposed regulations and alternatives to government intervention suggest that the resolution of the childhood obesity issue requires a coordinated, multilevel approach.
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Topics
Papers should provide an in-depth analysis of a current legal issue relevant to the regulation of foods, drugs, medical devices, cosmetics, and biologics. FDLI welcomes the submission of papers prepared for course work, but entrants must pay attention to competition details and edit such papers accordingly. Students should view the following topics listed below for suggestions of suitable topics or further information.
| Food | Drug | Medical Device | Biotechnology/Biologics | Other |
Food Topics
- Future of food safety issues
(pesticides/meat&poultry/eggs/HACCP/BSE) - Food labeling & dietary supplements/
structure/function claims - Medical foods/functional foods
- Food biotechnology (e.g., GMOs)
- Food irradiation
- Proposition 65 issues
a. reproductive toxins (alcohol, DES)
b. preemption
c. regulating through referendum - Use of antibiotics in food-producing animals
- Regulation of food by single agency
- Health claims & 1st Amendment issues
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- Drug approval process (e.g., comparative international, FDAMA issues,
and bioequivalence) - Drug reimportation
- Direct-to-consumer prescription drug advertising; promotional practices
- Orphan drugs
- Regulation of animal drugs
- Reporting adverse events
- Export of drugs
- Exclusivity issues (Hatch-Waxman Act; pediatric exclusivity)
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- Medical device reports of adverse events
- Pathways to market
- Promotional issues
- Device reclassification
- Mammography regulation
- Device re-use
- Regulation of software
- Diagnostic devices
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Biotechnology/Biologics Topics
- FDA regulation of tissue-based, cellular or gene-based therapies (e.g., transplantation
of peripheral blood, skin cells, human tissue) - Regulation of blood and blood products
- Regulation of vaccines
- FDA regulation of human cloning
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- Regulation of alternative therapies/medical treatment
- Regulation of cosmetic labeling and advertising
- State vs. federal government in food, drug, cosmetic, and device regulation
- International harmonization of food, drug, cosmetic, and device regulations
- Enforcement; enforcement authority and legislation; criminal; subpoena power; debarment
- Inspection issues
- Import and export of unapproved products
- Intellectual property and regulated products in the food, drug, cosmetic, device,
and biologics fields - FDA regulation of the Internet
- FDA legal history (evolving legal standards)
- Food, drug, device, and cosmetic definitional issues
- Medical errors
- Postmarket monitoring (safety issues)
- Use of industry standards in product approval
- Institutional review board (IRB) issues; oversight of clinical trials
- Terrorism as it relates to the food and drug law field
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Judges
Separate committees of practicing attorneys and law professors with relevant food
and drug law expertise will judge the papers in each competition. The following factors
will be considered:
- Thoroughness and depth of legal analysis
- Originality and difficulty of topic
- Evaluation of judicial precedents, statutes, and regulations
- Discussion of conclusions and future impact
- Quality of legal research
- Writing style
- Form and quality of citations
- Conformity with rules of competition
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H. Thomas Austern
These writing award competitions honor the memory of H. Thomas Austern, who practiced food and drug law for over fifty years at the firm of Covington & Burling. As a result of his work on the drafting and negotiation surrounding the Federal Food, Drug, and Cosmetic Act, and his many scholarly contributions, Austern became known as the "Dean of the food and drug bar." Austern served on the Editorial Advisory Board of the Food Drug Cosmetic Law Journal from its inception until his death in 1984, and was a strong supporter of FDLI since
its founding in 1949.
Send Submissions to:
Attn: Jean Everard |
Phone: |
*FDLI reserves the right not to grant any of the four H. Thomas Austern Writing
Competition awards.
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