About the Competition
The Food and Drug Law Institute (FDLI) sponsors the H. Thomas Austern Memorial Writing Competition 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.
The 2016 Competition submission period closed June 10. Winners will be announced in November.
1st place — $5,000 | 2nd place — $3,000 | 3rd place — $2,000
Students currently enrolled in a JD Program at any ABA-accredited law school or a 2015-2016 academic year graduate.
- Students should register for submission in our online competition portal; all papers must be submitted within the portal.
- Paper topics are limited to FDA and other regulated agency law. Topical focus should be on FDA regulated industries: food, drugs, animal drugs, biologics, cosmetics, diagnostics, dietary supplements, medical devices, and tobacco
- Students will submit an abstract.
- No author identifying information may be included in the body of the text. The author’s name should only be shared when registering.
- Papers shall not exceed 100 pages (assuming double spacing, one-inch margins).
- Papers shall include footnotes, not endnotes. Text and footnote type shall be in 12-pt. Times Roman font.
- Papers must be submitted no later than midnight, June 10th 2016.
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.
Judges and Considerations
A committee of practicing attorneys and law professors with relevant food and drug law expertise will judge the papers. The following factors will be considered:
- Thoroughness and depth of legal analysis
- Originality and difficulty of topic
- Evaluation of judicial precedents, statutes, and regulations
- Quality of thesis/argument
- Quality of legal research
- Writing style
- Conciseness; quality will be valued over quantity
- Form and quality of citations
- Conformity with requirements 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.
- 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
This writing award honors 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 scholar contributions, Austern was known as the “Dean of the Food and Drug Bar.” Austern was a strong supporter of FDLI since its founding in 1949, serving on the Editorial Advisory Board of the Food Drug Cosmetic Law Journal from its inception until his death in 1984.
Please contact Meghan Crowley, Manager, Program Innovation
* FDLI reserves the right not to grant any of the H. Thomas Austern Writing Competition awards.