Partner, Washington DC
1900 K Street NW
Washington, DC 20006-1108

TEL: 202.496.7561
FAX: 202.496.7756
EMAIL: lpilot@mckennalong.com

PROFILE

Larry Pilot is a specialist in administrative and products liability law with particular emphasis on matters relating to products subject to regulation by the U.S. Food and Drug Administration (e.g., foods, drugs, and medical devices), and state and international controls applicable to such products.

Mr. Pilot has been involved in the practice of food and drug law for thirty years. He is recognized as an authority on legal issues relating to development, investigation, manufacture, and distribution of FDA regulated products, in particular medical devices. During his years of practice, he has represented food and drug clients in many facets of enforcement, ranging from inspection/scientific review disputes through civil/criminal litigation. Mr. Pilot regularly represents domestic and international developers, investigators, manufacturers, and distributors of drugs, devices and other FDA regulated products in areas relating to compliance.

Mr. Pilot is a frequent speaker and author on the law relating to compliance with and enforcement of laws administered by the FDA. He is a member of the Editorial Advisory Board of Medical Device and Diagnostic Industry Magazine and in 2004 was recognized among the 100 notable people in the device industry. He also is a founder of the Medical Device Manufacturers Association.

From 1969 to 1979, Mr. Pilot was employed by the FDA where he was a Special Assistant to the Commissioner and later was responsible for the development of FDA's regulatory program for medical devices prior to and after the passage of the Medical Device Amendments of 1976. In 1978 Mr. Pilot received the FDA Award of Merit for outstanding contributions in the development of the overall FDA medical device programs and significant achievement in the design of GMP regulations. At the time he left FDA to engage in private practice, he was Associate Director for Compliance, Bureau of Medical Devices.

From 1966 to 1969, Mr. Pilot was employed by the Pharmaceutical Manufacturers Association (now PhRMA) as manager of special projects, and later, as a staff attorney focusing on matters relating to state and federal regulation of pharmaceuticals. From 1964 to 1966 he was employed by the American Pharmaceutical Association as Assistant Director of Communications.

Mr. Pilot is a registered pharmacist in the State of Michigan .