As Director of CDER’s Office of Compliance, Donald D. Ashley, J.D., leads efforts to protect the American public from unsafe, ineffective and low-quality drug products through measures designed to assist industry-wide compliance with federal standards for quality and safety, as well as regulatory and enforcement measures to address violations of those same standards.
Mr. Ashley joined FDA after more than 18 years of criminal enforcement and investigation experience with the Department of Justice (DOJ). His many positions with DOJ included serving as a Trial Attorney in the Office of Consumer Litigation (now the Consumer Protection Branch), where he prosecuted consumer fraud offenses and violations of the Food Drug and Cosmetic Act (FD&C Act), and as Associate Director of the Office of International Affairs, where he managed international criminal law enforcement cooperation with countries throughout the world, represented DOJ’s interests within the United Nations, and negotiated law enforcement cooperation treaties.
In addition, Mr. Ashley served as the DOJ Attaché stationed at the U.S. Embassy in Rome, Italy, where he was responsible for facilitating closer cooperation between Italy and United States in organized crime and terrorism investigations. Mr. Ashley also served as the DOJ Attaché at the U.S. Embassy in Manila, Philippines, where he managed international law enforcement collaboration on behalf of the United States with the Philippines, Singapore, Malaysia and Indonesia. His work focused on money laundering, public corruption, bribery, and fraud investigations.
Before joining DOJ, Mr. Ashley served as senior litigation associate with the King & Spalding law firm, specializing in white-collar criminal defense work, often involving clients under investigation for FD&C Act violations. He also served on active duty as an Army captain assigned to the Office of General Counsel, Department of the Army. Mr. Ashley was an adjunct professor of law at Georgetown, George Washington, American, and Catholic Universities teaching a course on the role of federal prosecutors. He also served as vice president of the Board of Trustees at the International School Manila while in the Philippines.
Mr. Ashley received a bachelor’s degree in political science from John Carroll University in Ohio and earned a law degree from Harvard Law School.