Jill B. Deal focuses on laws governing consumer products, including therapeutic products regulated by the Food and Drug Administration ("FDA") and consumer products regulated by the Consumer Product Safety Commission ("CPSC").  She engages in practice before federal agencies as well as in litigation and lobbying.  As a result of practicing in the European Union ("EU") for over a decade and living abroad for over fifteen years, she is an expert in counseling non-U.S.-based companies with respect to conducting regulatory activities in the U.S. and domestic companies with respect to conducting these activities abroad.  In that regard, she participated in the EU implementation of the Medical Devices Directive, and served on the EU-based Board of the Regulatory Affairs Journal (Devices) for many years.

Ms. Deal has provided counsel on numerous successful drug (including OTC drugs), device, biologic and cosmetic issues and appeals in the U.S. and the EU, and has successfully represented companies in complex litigation involving regulatory approvals and other issues, including those arising from the Hatch/Waxman amendments to the Food Drug and Cosmetic Act.  She has served as an expert witness on these issues in two multi-state antitrust class actions.

Recent international activities include on-going work with a client and medical consultants to prepare a Common Technical Document that will enable a U.S. client to file applications for drug licenses in the EU and China, and development, together with firm intellectual property experts, of a multi-pronged anti-piracy strategy to prevent widespread counterfeiting of consumer products in Latin America.  To prepare for a rapid response to a possible Congressional Investigation, she also coordinated a U.S./EU compliance team involving international discovery and review of documents in France and Germany for a recalled product with possible joint FDA/CPSC jurisdiction.  She has coordinated a number of international food and drug recalls.  Working with a Canadian regulatory consultant, she successfully convinced the National Boards of Pharmacy in Canada to switch a drug ingredient from Pharmacy Only Sales to General Sales and is in the process of convincing the Office des Professions in Quebec to make the same change.  Due to her extensive network abroad of legal and other contacts, she is frequently called upon to partner U.S. companies either venturing abroad for the first time, or venturing into uncharted international areas.

Activities

Ms. Deal has served as Vice Chair of the Food and Drug Committee, Administrative Law section of the ABA.  She authored a chapter in the Homeland Security Deskbook (Matthew Bender 2006) on drug and device development for bioterrorism and homeland security purposes.  In July 2003, she planned and co-chaired the Food and Drug Law Institute's (FDLI) first meeting on biosimilars.  In 2004, she co-chaired and organized FDLI's first meeting on scientific issues raised by biosimilars.  In 2010 and 2011, she participated in the European Healthcare Compliance Ethics and Regulatory Program sponsored by Seton Hall Law School and Science Po in Paris, lecturing on EU/U.S. Pharmaceutical Harmonization Issues.  In 2010 and 2011 she presented at and co-chaired the American Conference Institute's European Pharmaceutical Regulatory Law Boot Camp.  In 2011, she has authored a number of articles for the Bureau of National Affairs on the CPSC's new safety database, SaferProducts.gov, and moderated a breakout session on it at the FDLI 2011 Annual Meeting, as well as conducted a webinar for the Personal Care Products Council, focusing on cosmetics.