Jill Hartzler Warner, J.D., joined the FDA's Office of the Chief Counsel in 1986. In August 2009 she was appointed Acting Associate Commissioner for Special Medical Programs at FDA and was made the permanent Associate Commissioner for Special Medical Programs in May 2014. Ms. Warner oversees, directs, and provides leadership for FDA's Office of Pediatric Therapeutics, Office of Orphan Products Development, Office of Good Clinical Practice, Office of Combination Products, and the Advisory Committee Oversight and Management Staff. Her responsibilities include:
- internal and external review of pediatric science, safety, and ethics to assure access for children to innovative, safe and effective medical products
- implementing the Orphan Products provisions of the Federal Food, Drug, and Cosmetic Act to encourage the development of therapies with limited commercial value for use in rare diseases and conditions
- promoting the development of Good Clinical Practice through human subject protection regulation, policy, harmonization, and outreach activities
- resolving issues involving the regulation of combination products, the classification of human medical products, and jurisdiction over human medical products
- directing development of policy, procedures, and processes to maintain and improve the agency’s advisory committee program
Ms. Warner received her law degree from the University of Virginia in 1985. During her first ten years with the agency, she held various positions including assistant chief counsel for enforcement, associate chief counsel for veterinary medicine, and associate chief counsel for biologics. Since 1996, she has served the agency in other senior positions, including senior policy advisor and counselor for biologics, Office of the Director, Center for Biologics Evaluation and Research (1996-2006); senior policy advisor and counselor, Office of Policy, Planning, and Preparedness, Office of the Commissioner (2006-2009), and acting assistant commissioner for accountability and integrity, Office of the Commissioner (2009).