The Food and Drug Law Institute (FDLI) sponsors the H. Thomas Austern Memorial Writing Competitions to encourage law students interested in the areas of law that affect food, drugs, animal drugs, biologics, cosmetics, diagnostics, dietary supplements, medical devices and tobacco. 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.
1st place — $4,000 | 2nd place — $1,000 Winners will be announced in October 2013.
Two prizes will be awarded for each of the two competitions.*
Who is Eligible
Entrants must be currently enrolled in a J.D. program at any of the nation's "ABA-accredited" law schools or a 2012-2013 academic year graduate.
Noncompliance with these requirements will affect evaluation and may result in disqualification.
- Papers for the short paper competition shall not exceed 40 pages in length, including appendices (if any) and footnotes, which may be single-spaced. The maximum number of pages for the long paper competition is 100 pages (41-100 pages).
- Submission must include a cover page that includes paper title and a 250 word or less abstract.
- Papers may not include any identifying information.
- Submissions shall be typewritten, double-spaced on 8½ x 11 inch paper.
- The submission must be a WORD® document, printouts of which should conform to all other paper requirements.
- 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).
Deadline: Papers must be received no later than JUNE 7, 2013.
We do accept submissions that have been submitted to other writing contests, however, if you win FDLI’s competition and are chosen to be published in the Food and Drug Law Journal it must be the first publication that includes your article.
Winners of the 2012 H. Thomas Austern Memorial Writing Competitions:
Long Paper Competition
1st Place: Jessica Palmer, Harvard Law School, Genetic Gatekeepers: Regulating Direct-to-Consumer Genomic Services in an Era of Participatory Medicine
2nd Place: Abraham Gitterman, University of Maryland, Manufacturing a Solution: How the U.S. Food and Drug Administration Can Ensure the Safety and Security of a Globalized Drug Supply Chain
Honorable Mention: Janet Freilich, Harvard Law School, The Paradox of Legal Equivalents and Scientific Equivalence: Reconciling Patent Law’s Doctrine of Equivalents with the FDA’s Bioequivalence and Biosimilarity Requirements
Short Paper Competition
1st Place: Leandro Delgado, Harvard Law School, Impact and Desirability of OMB Oversight of FDA Rulemaking
2nd Place: Stefanie Gregory, University of North Carolina, Harm Reduction Approach to Tobacco-Related Diseases: A Case for the FDA to Interpret Electronic Cigarettes as “Special Modified Risk Tobacco Products” Under the Tobacco Act
Honorable Mention: Rachel Sanchez, Harvard Law School, The Critical Path from Pump to Pancreas
Honorable Mention: Tacy Hass, University of Colorado, New Governance: Can User-Promulgated Certification Schemes Provide Safer, Higher Quality Food?
Judges and Considerations
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
- Conciseness; quality will be valued over quantity
- Form and quality of citations
- Conformity with rules of competition
Papers should provide an in-depth analysis of a current legal issue concerning food, drugs, animal drugs, biologics, cosmetics, diagnostics, dietary supplements, medical devices or tobacco. FDLI welcomes the submission of papers prepared for course work, but entrants must pay attention to competition details and edit such papers accordingly. Entrants should view the following topics listed below as examples of suitable topics or further information.
- Future of food safety issues
- 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)
c. regulating through referendum
- Use of antibiotics in food-producing animals
- Regulation of food by single agency
- Health claims & 1st Amendment issues
- 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)
Medical Device Topics
- Medical device reports of adverse events
- Pathways to market
- Promotional issues
- Device reclassification
- Mammography regulation
- Device re-use
- Regulation of software
- Diagnostic devices
- 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
- Tobacco-related product regulation
- 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
H. Thomas Austern
These writing awards honor the memory of H. Thomas Austern, who practiced food and drug law for more than 50 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.
Attn: Writing Awards Competition
The Food and Drug Law Institute
1155 15th Street, NW, Suite 800
Washington, DC 20005
* FDLI reserves the right not to grant any of the four H. Thomas Austern Writing Competition awards.