Mark Heller serves as chair of the firm’s FDA Group and is a member of the Life Sciences Practice. He focuses on Food and Drug Administration and Federal Trade Commission laws and enforcement counseling and litigation.

Work for Clients

Mr. Heller represents a broad base of clients in all aspects of the FDA’s product approval processes, and in compliance matters ranging from administrative notices of violation to enforcement actions. He also represents clients in obtaining device and drug approvals, in responding to agency investigations, for example, those concerning device and drug promotion, good manufacturing practices, product importation, and in filing comments within the agency to help shape regulatory and policy initiatives. An important part of Mr. Heller’s practice is developing strategies with clients to maximize their effectiveness in dealing with the FDA’s processes.

In addition to his regulatory practice before the FDA and FTC, Mr. Heller represents trade associations and companies before Congress. He has successfully represented AdvaMed, formerly the Health Industry Manufacturers Association, and a coalition of medical device trade associations as legislative counsel in achieving reform of the Federal Food, Drug and Cosmetic Act through the Food and Drug Administration Modernization Act of 1997. Mr. Heller also assisted AdvaMed in obtaining further amendment of the Act’s device provisions through the Medical Device User Fee and Modernization Act of 2002 and subsequent technical amendments, and presently, assists that organization on a number of legislative issues.

Professional Activities

Mr. Heller is listed in Chambers USA: America’s Leading Lawyers for Business and The Best Lawyers in America. He is prominently featured as one of three “leading” lawyers in the 2006/2007 PLC Cross-border Life Sciences Handbook in the USA Regulatory [medical devices] category. Mr. Heller was also named a “Leading FDA Lawyer” in 2005 by the Legal Times, which recognized him as an “intellectual powerhouse” and praised his significant knowledge of the law on medical devices and his specialty – “getting the green light from the FDA.” He was selected by Washingtonian magazine in 2004 as one of the top lawyers in Washington, D.C. in the area of food and drugs, and recently, a “D.C. Super Lawyer.”

Publications/Presentations

Mr. Heller has lectured widely on medical device law and has participated in teaching courses on device regulation. He is the author of Thompson Publishing’s Guide to Medical Device Regulation, and has authored and co-authored chapters in texts on crisis management and the regulation of biomaterials.

Professional Experience

Prior to joining Goodwin Procter in 2007, Mr. Heller was chair of the FDA Department at WilmerHale. Before that, he spent almost 10 years in the FDA’s Chief Counsel’s office, where he was actively involved in offensive and defensive litigation, including drug and device cases. During his last six years with the FDA, Mr. Heller was the associate chief counsel for medical devices responsible for the legal aspects of the agency's combination product, device enforcement, premarket notification, investigational device exemption, reclassification and premarket approval programs. He also was involved in the development of the Safe Medical Devices Act of 1990 while on detail to the office of the chairman (Senator Edward M. Kennedy) of the Senate Committee on Labor and Human Resources.

Before joining the FDA, Mr. Heller was with the Federal Trade Commission for eight and a half years. He focused on the regulation of food, drug and device advertising. Mr. Heller has received several awards for excellence for his work at both the FDA and FTC.

Bar and Court Admissions

Mr. Heller is admitted to practice in the District of Columbia.

Education

J.D., University of Wisconsin-Madison Law School, 1973
B.A., University of Wisconsin-Madison, 1970 (with honors)