Richard Klein

Richard Klein is the director of the FDA’s Patient Liaison Program in the Office of Health and Constituent Affairs, the primary interface between the agency and patient and patient advocate communities. The program interacts extensively with outside communities and within the agency’s scientific and policy offices to facilitate patient engagement, and to address issues and concerns of patients in a variety of areas, including treatment access to unapproved drugs, product safety, and clinical trial design. The program ensures that patient communities are represented in approval and policy decisions, and at FDA advisory committee meetings.Mr. Klein has been with the agency for more than 30 years, and has worked in various capacities giving him a well-rounded understanding of the regulatory issues that affect patients. He participated in the development revised expanded access regulations and guidelines. He also developed the agency’s patient web pages, and disease-specific electronic list serves.Immediately prior to becoming the Patient Liaison Program Director, he managed the agency’s HIV/AIDS Program. Earlier, he was involved in Human Subject Protection policy development for the agency, working closely with other federal agencies and the Department of Health and Human Services to ensure consistent and meaningful policy for the protection of human subjects of biomedical research.