|Larry Pilot, JD|
As a former association executive and government official, Larry Pilot has maintained a practice of law that is directly related to the performance of FDA as it affects the manufacture, distribution, and use of products subject to its authority for import, domestic use, and export. After employment by professional and trade associations in Washington, DC, from 1964 to 1969, he was appointed to a position during the Nixon administration relating to supervision of FDA activities. He became the special assistant to the new FDA Commissioner in December 1969, where he had major responsibilities for a broad range of product-related activities. In 1971, Mr. Pilot participated in the creation of the Office of Medical Devices and remained responsible for development and management of regulatory programs at headquarters and throughout the United States. He also initiated a program to inspect foreign device manufacturers. FDA recognized him with the highest Award of Merit for his management of regulatory responsibilities. He resigned from FDA in 1979 to establish a law practice. He assists domestic and foreign businesses in their efforts to comply with laws and regulations administered by FDA. These efforts range from general counseling to administrative and federal court litigation with a particular emphasis on preparation for and management of inspections conducted by FDA inspectors in the United States and abroad. Mr. Pilot is the author of scores of publications relating to application of and compliance with food and drug law. He has been a frequent speaker both during his tenure at FDA and during his law practice on FDA compliance- and enforcement-related activities. Mr. Pilot has accomplished numerous dispute-resolution successes through federal court litigation for which their performance and successful representation of clients is unique among the food and drug bar in the United States. He has been a member of MD&DI's Editorial Advisory Board since 1979.