SharePrinter-friendly versionSend by emailA TitleA TitleA Title A A A Joanne S. Hawana TabsetOverviewBar & Court Admission Bar & Court Admissions District of Columbia Bar Maryland Bar Education University of Maryland School of Law, JD, (cum laude), 2007 University of Medicine and Dentistry, Graduate School of Biomedical Sciences, MS, (molecular genetics and microbiology), 2002 The College of William and Mary, BS, (biology), 1999 Joanne S. HawanaAssociateWashington, DC T 202.715.8591 E joanne.hawana@arentfox.com Download vCard Joanne focuses her practice on government oversight of foods, drugs, and devices, as well as wholesale distribution and pharmacy activities. She advises foreign and domestic clients on various aspects of getting a new product to market, promoting and distributing the regulated product, and ensuring ongoing compliance with federal and state requirements. Joanne has assisted numerous entities engaged in prescription drug wholesale distribution in complying with their state-imposed licensure and pedigree obligations. She regularly works with foreign manufacturers and importers to gain entry of drugs, medical devices, foods, and dietary supplements into the United States. She also advises clients on various issues related to the commercialization and regulation of biotechnology-derived products, including food safety and environmental implications of such products. Previous Work Prior to joining Arent Fox, Joanne was a student attorney for the Maryland Intellectual Property Legal Resource Center and a legal intern at the Biotechnology Industry Organization (BIO). She also spent a summer as a National Institutes of Health Fellow working with the National Science Advisory Board for Biosecurity. Before attending law school, Joanne was an editor and reporter for a science policy and biomedical research trade newsletter; and before becoming a reporter, she conducted fundamental research on the regulation of gene expression, with a focus on cancer genetics. Professional Activities Joanne serves on the Food and Drug Law Institute’s Monograph Editorial Advisory Board, which advises on the content and substance of the organization’s Monograph publications. Publications, Presentations and Recognitions In March 2012, Joanne participated in the Distribution Management Conference and Technology Expo, co-hosted by the Healthcare Distribution Management Association and the International Federation of Pharmaceutical Wholesalers. She presented an update on state pedigree and licensing laws to an audience of executives representing manufacturers, distributors, and other members of the health care supply chain. Joanne regularly writes for various Food and Drug Law Institute publications and in April 2011, she co-edited an FDLI book titled “Personalized Medicine: Prescriptions and Prospects.” “A Long Time Coming: Dietary Supplement GMPs No Longer Discretionary,” FDLI Update magazine (September/October 2010, Issue 5) “Are Federal Regulations in a Funk Over Functional Foods?,” FDLI Update magazine (September/October 2009, Issue 5) (co-written with Brian Waldman); “Drug Pedigree Rules In Effect, Yet Remain in Flux,” FDLI Update magazine (November/December 2008, Issue 6). “Non-Medical Application of Reproductive Genetic Technologies Highlight the Pressing Need for Government Oversight: Sex Control by Prospective Parents Raises Concerns about Discrimination,” Biotech Briefing/Newsletter of the Biotechnology Committee, ABA Section of Science and Technology Law,Vol. 3, No. 2, spring 2007. Life Beyond the Law Joanne spends her free time with her husband, Thatcher, and together they enjoy cooking (and eating), hiking, and biking. They also enjoy traveling and are fortunate to have family members in many countries, so they always have a good excuse to visit somewhere new. Newsroom Date Type Title 1 / 8 / 2013 Alert FDA Releases Two Significant and Far-Reaching Proposals to Implement Food Safety Overhaul Legislation 12 / 6 / 2012 Alert First Amendment Protects Off-Label Promotional Speech, Second Circuit Holds 4 / 13 / 2012 Press Release Arent Fox's Larri Short and Joanne Hawana Published in Law360 – “New VA Restrictions On Drug Co. Detailing Activities” 3 / 20 / 2012 Alert US Department of Veterans Affairs Restricts Drug Company Detailing Activities 1 / 20 / 2012 Alert New FDA Drug User Fees on the Horizon 10 / 27 / 2010 Alert “A Long Time Coming: Dietary Supplement GMPs No Longer Discretionary”, Update magazine, an FDLI publication, 2010, Issue 5 3 / 8 / 2010 Alert FDA Commissioner Calls for More Compliant Food Labeling 11 / 4 / 2009 Alert EPA Finalizes Mandatory Reporting System for Large Greenhouse Gas Emitters 9 / 29 / 2009 Alert Are Federal Regulators in a Funk Over Functional Foods? 9 / 15 / 2009 Alert FDA Launches Electronic Portal for Food-Safety Reporting 8 / 21 / 2009 Alert FDA Finalizes Rules Aimed at Increasing Access to Investigational Drugs 4 / 10 / 2009 Alert EPA Proposes Mandatory Reporting System for Large Greenhouse Gas Emitters 1 / 16 / 2009 Alert FDA Clarifies Clinical Trial Adverse Event Reporting Obligations 1 / 15 / 2009 Alert FDA to Host February 12 Public Workshop on Developing a Unique Identification System for Medical Devices 1 / 15 / 2009 Alert FDA Finalizes Off-Label Reprint Guidance for Industry 12 / 23 / 2008 Alert Regulating Greenhouse Gas Emissions in an Obama Administration: Change Is Coming 11 / 24 / 2008 Press Release Drug Pedigree Rules In Effect, Yet Remain in Flux 10 / 30 / 2008 Alert Supreme Court to Rule on Controversial Drug Labeling Preemption Issue This Term 4 / 2 / 2008 Alert California Delays E-Pedigree Implementation for Prescription Drugs Until January 2011 2 / 21 / 2008 Alert FDA Publishes Draft Guidance for Industry on Good Reprint Practices
