As Director of CDER’s Office of Compliance (OC), Donald D. Ashley, J.D., leads efforts to protect the American public from unsafe and ineffective drug products by ensuring that companies comply with federal standards for quality and safety.
Mr. Ashley has more than two decades of compliance and enforcement experience in criminal and fraud investigations. Eighteen of those years were with the Department of Justice, where he served as Associate Director of the Office of International Affairs and managed international law enforcement collaboration with Canada and the Caribbean. He represented DOJ’s interests at the United Nations and the Group of Seven (G-7). From 2012 until 2016, he served with the U.S. Embassy in Manila, Philippines, where he managed international law enforcement collaborations on behalf of the United States with the Philippines, Singapore, and Indonesia. His work focused on such issues as money laundering, public corruption, bribery, and fraud.
Before joining DOJ he conducted internal investigations related to FDA-regulated activities as Senior Litigation Associate with King & Spalding law firm and as an Army captain with the Office of General Counsel, Department of the Army. Mr. Ashley was adjunct professor of law at Georgetown, George Washington, American, and Catholic Universities. He served as vice president with the Board of Trustees at the International School Manila while in the Philippines.
Mr. Ashley holds a bachelor’s degree in political science from John Carroll University in Ohio and a law degree from Harvard Law School.