Jonathan A. Havens

Associate

Jonathan A. Havens is an associate in Morgan Lewis's FDA Practice. His practice focuses on FDA and healthcare regulatory, compliance, enforcement, and transactional issues. In this capacity, Mr. Havens represents clients in matters relating to medical devices, prescription and non-prescription pharmaceuticals, foods, food additives, dietary supplements, and cosmetics, as well as marketing, promotion, and advertisement. He assists clients in various matters related to state regulatory requirements, including state licensing requirements, for healthcare providers and pharmacies, as well as drug and device manufacturers and distributors. 

Mr. Havens advises clients on regulatory and compliance matters of the Consumer Product Safety Commission, the Drug Enforcement Administration, the Department of Veterans Affairs, the Small Business Administration, and Customs and Border Protection. His experience includes representing clients before the Food and Drug Administration, the Department of Health and Human Services, and the Consumer Product Safety Commission.

Prior to joining Morgan Lewis, Mr. Havens was a regulatory counsel with the U.S. Food and Drug Administration. While at the FDA, Mr. Havens received an FDA Group Recognition Award for Compliance and Enforcement of Tobacco Product Regulations and a Center for Tobacco Products Team Excellence Award. Before his legal career, Mr. Havens was a legislative aide in the U.S. Senate and U.S. House of Representatives, as well as a legislative specialist with a national law firm.

Mr. Havens's recent representative client matters include:

• Represented a multinational pharmaceutical company in its successful request for orphan drug designation
• Represented a medical device company in a pair of successful applications for marketing clearance
• Represented a mail order pharmacy in its sale of stock to a pair of private equity groups

Mr. Havens maintains an active pro bono practice, and has represented clients before the D.C. Superior Court, the Social Security Administration, and the Centers for Medicare and Medicaid Services and related state agencies.

Beyond his representational experience, Mr. Havens has written and spoken about federal and state health industry transparency requirements, and he is member of the Morgan Lewis Health Industry Transparency Compliance Team. He has also written about pharmacy billing practices and food safety.

Mr. Havens earned his J.D. from the Catholic University of America, Columbus School of Law in 2010, where he was an associate editor for the Catholic University Law Review. He earned his B.A. in American politics from the University of Virginia in 2005, where he graduated on the Dean's List.