Jennifer Zachary

Jennifer Zachary is an associate in the firm’s food and drug practice group. She advises companies and industry associations on complying with FDA requirements for the production and marketing of pharmaceuticals, medical devices, foods and dietary supplements and assists clients in responding to FDA inspections, Warning Letters, recalls and import detentions. Ms. Zachary joined the firm from the FDA’s Office of Chief Counsel, where she served as an Associate Chief Counsel for Enforcement from 2005 to 2011. While at FDA, Ms. Zachary brought numerous enforcement actions in conjunction with Department of Justice co-counsel against adulterated and misbranded drugs, devices, foods and dietary supplements. In addition, she served as counsel to FDA’s Office of Regulatory Affairs, reviewing Warning Letters for legal sufficiency and advising investigators and compliance personnel in FDA’s regional and district offices. During her government tenure, Ms. Zachary also served for six months as a Special Assistant U.S. Attorney in the Civil Division of the U.S. Attorney’s Office for the District of Columbia. REPRESENTATIVE MATTERS Advise on issues relating to the labeling, marketing and promotion of FDA-regulated products. Represent in connection with FDA-related investigations and seizure and injunction actions. Draft responses to FDA Warning Letters and FDA-483 Inspectional Observations. Assist with Hatch-Waxman issues regarding exclusivity, citizen petitions and litigation strategy. Provide strategic advice regarding safety reporting requirements for marketed products. Conduct regulatory due diligence evaluations for mergers and acquisitions. PREVIOUS EXPERIENCE U.S. Food and Drug Administration, Associate Chief Counsel for Enforcement (2005-2011) U.S. Attorney’s Office for the District of Columbia, Civil Division, Special Assistant U.S. Attorney (2009) PUBLICATIONS AND SPEECHES "Trends in Recent OTC Enforcement Actions and Litigation," American Conference Institute Legal, Regulatory, and Compliance Forum on Over-the-Counter Drugs (10/19/2012) "Drug Shortages: Key Provisions of the New Legislation," LogiPharma 2012 Conference (10/10/2012) "Rogue APIs: How to Detect and Reject Them," FDANews Fourth Annual Supplier Quality Management Congress (8/1/2012)