FDLI's H. Thomas Austern Memorial
Writing Competitions (with a 1st Place Prize now at $4,000!)
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The Competitions | Illustrative Topic Areas |
| Prizes | Topics | |
| Who is Eligible | Judges | |
| Paper Requirements | H. Thomas Austern |
•• View Winners of FDLI's 2007-2008 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 12, 2009.
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Illustrative Topic Areas
Winning Paper Titles From Competitions in Previous Years
| 2008 | 2007 |
Short Paper Competition (< 40 pages)
First Place ($1500) – Michael Kolber, Harvard Law School
Direct Final Rulemaking in the FDA: Lessons from the First Decade
In an effort to improve efficiency, several administrative agencies, including the Food and Drug Administration (FDA), have adopted a procedure known as “direct final rulemaking” (DFR). Some academics have debated whether DFR violates the Administrative Procedure Act, but none have studied how DFR has functioned in practice. This paper, which examines the first decade of DFR at the FDA, is the first of this kind. The results are surprising, and suggest DFR deserves more study than it has received. Intended for noncontroversial rules that are expected to receive no significant comments in a notice-and-comment rulemaking, FDA has often used direct final rulemaking for the opposite: regulations that may be expected to be controversial. Far from generating few comments, forty percent of DFRs have had to be withdrawn due to significant opposition. These findings suggest greater limits be placed on the use of direct final rulemaking and that its legality be re-evaluated in light of how the procedure is actually used.
Second Place ($1000) – Shengfeng Chen, University of California,
Hastings College of the Law
Pathways To Patents: Applying the Written Description Requirement Doctrine
To Patents On Biological Pathways
In recent years, patenting biological functions has become the central topic of the debate over biotech patent policy. Courts have faced increasingly difficult questions such as research tool patents, and “reach-through” claims. The concern over patenting biological functions reached its high-water mark when the Supreme Court granted certiorari in Labcorp v. Metabolite, where the disputed patent claimed a correlation between an elevated level of homocysteine and a deficiency in B vitamins in humans.
Metabolite, the licensee of the patent, sublicensed the patent to Labcorp. When an alternative method of homocysteine assay became available on the market, Labcorp switched to the alternative assay and discontinued royalty payments to Metabolite. Thereafter, Metabolite sued Labcorp, alleging that the use of the alternative assay infringed its patent. The Federal Circuit held that the patent was valid and that Labcorp willfully infringed the patent. Labcorp filed a petition for certiorari to the Supreme Court, contending that the patent claim was invalid as unpatentable subject matter. After hearing oral arguments, the Supreme Court dismissed the writ of certiorari as improvidently granted because the issue presented was not raised in the decision below.
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Long Paper Competition (40-100 pages)
First Place ($1500) – Benjamin R. Rossen, Harvard Law School
FDA’s Proposed Regulations to Expand Access to Investigational Drugs for Treatment Use: The Status Quo in the Guise of Reform
On December 14, 2006, the Food and Drug Administration (FDA) proposed two new regulations in the Federal Register amending current regulations governing expanded access to investigational drugs for treatment use and charging for investigational drugs. The proposal comes at a time when FDA has been under new pressure to provide seriously ill patients with early access to investigational drugs outside the framework of clinical trials. In recent years, patient advocacy groups have filed citizen petitions with FDA asking the agency to provide specific criteria for obtaining access or to create an early approval mechanism to provide access. Further, FDA has seen proposed federal legislation intended to ensure early patient access to investigational treatments and nearly lost a lawsuit in federal court in which terminally ill patients sought a fundamental right of access to investigational therapies under the Due Process Clause of the Constitution.
This article examines the proposal in light of historical agency regulation and recent pressures to expand access.
Second Place ($1000) – Matthew Gordon, Harvard Law School
Why Researchers Might Have a Legal Duty to Disclose Individual Research Findings to Research Subjects
Exploration of the frontiers of biomedical research requires the willing participation of millions of human subjects. This participation primarily facilitates breakthroughs in generalized knowledge, but it also reveals personal information about the human subjects, some of which is potentially significant. Researchers who possess such personal information about the subjects of their studies arguably have, or should have, a legal duty to inform the subjects, at least when the information is medically significant. While there is no such explicit duty in positive law and none has been previously announced by a common law court, some courts have softened the requirements for finding that physicians and life insurers have such a duty in analogous situations. The law has thus developed that finding researchers have a similar duty would appear to be a logical next step. In fact, the argument for a duty to disclose for researchers is arguably even stronger. Courts faced with litigation alleging a researcher’s duty to disclose should not, however, merely import the reasoning from the analogous cases because doing so would further cloud the already fuzzy state of the interaction between researchers and subjects.
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Short paper competition View Abstracts
- Mandatory Labeling of Foods Made From Cloned Animals: Grappling with Moral Objections to the Production of Safe Products
- Plan BTC for the FDA: The Case for a ‘Third Class’ of Drugs in the U.S.
- The FDA’s Decision to Make Emergency Contraception Available Without a Prescription: Guaranteed Access for Women or Just the First Step?
Long paper competition View Abstracts
- Staving Off Death: An Assessment of the Pharmaceutical Industry’s Strategies to Protect Blockbuster Franchises Upon the Loss of Marketing Exclusivity
- Is My Yogurt Lying? Developing and Applying a Framework for Determining Whether Wellness Claims on Probiotic Yogurts Mislead
- Perspectives on FDA’s Regulation of Nanotechnology:
Emerging Challenges and Potential Solutions - Reverse-FOIA Limitations on Agency Actions to Disclose Human Gene Therapy
Clinical Trial Data
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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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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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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: Writing Awards Competition |
Phone: (800) 956-6293 |
*FDLI reserves the right not to grant any of the four H. Thomas Austern Writing
Competition awards.
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