Donald Ashley, Former Director of CDER Compliance, Joins Firm

Donald Ashley, a former senior official with the Food and Drug Administration (FDA) has joined the company as Executive Vice President. Greenleaf Health, an ELIQUENT Life Sciences Company, is a leading consulting firm for companies regulated by the FDA.

Donald Ashley is an expert in compliance and enforcement matters and joins Greenleaf Health following a distinguished 25-year career at the FDA and the Department of Justice (DOJ), including six years as Director of CDER’s Office of Compliance at the FDA.

As Director of CDER’s Office of Compliance, Don led a staff of over 400 lawyers, scientists, consumer safety officers, pharmacists, and physicians. He oversaw development and implementation of the FDA’s entire breadth of drug compliance and enforcement measures, including for manufacturing quality, current good manufacturing practice, good clinical practice, data integrity, clinical trial oversight, pharmacovigilance, drug supply chain security, compounding, over-the-counter monograph compliance, drug import and export, and unapproved drug compliance, among other areas. Don led all drug compliance actions taken by the FDA following inspection, as well as all grants of regulatory discretion in drug shortage cases.

As an executive member of CDER’s Drug Risk Management Board, Don helped guide the Agency’s approach to some of most difficult drug safety issues over the last several years, including for nitrosamine and benzene impurities. In addition, Don served as one of a small group of senior agency officials who liaised with the generic drug industry to implement the Generic Drug User Fee Act program.

Before joining the FDA, Don spent nearly two decades at DOJ in both the Civil and Criminal Divisions, prosecuting violations of the Food, Drug, and Cosmetic Act among other criminal statutes, as well as managing and directing investigations on both a national and international level. Don earned his J.D. from Harvard Law School and an A.B., magna cum laude, from John Carroll University.

“I will be eternally grateful for having had the opportunity to serve with and learn from so many dedicated and talented colleagues during my 25-year career at FDA and DOJ. I’m excited to join the Greenleaf team and look forward to helping our clients navigate their most challenging regulatory, compliance, and enforcement matters,” said Don.

Learn more about Don’s experience and his role at Greenleaf Health.

About Greenleaf Health

Greenleaf is guided by experts with a combined total of more than 300 years of FDA experience. Sandy and Don join a distinguished group of professionals at Greenleaf who previously served as leaders throughout the Agency, including: John Taylor, former FDA Counselor to the Commissioner and Principal Deputy Commissioner; Dr. Daniel Schultz, former Director of the FDA’s Center for Devices and Radiological Health (CDRH); Dr. Karen Midthun, former Director of the FDA’s Center for Biologics Evaluation and Research (CBER); Dr. John Jenkins, former Director of the Office of New Drugs for the FDA’s Center for Drug Evaluation and Research (CDER); Dr. Robert Meyer, former Director of CDER’s Office of Drug Evaluation II; Heather Rosecrans, former Director of CDRH’s 510(k) staff; David Elder, former Director of the FDA’s Office of Regional Affairs and Office of Enforcement; Cynthia Schnedar, former Director of CDER’s Office of Compliance; and Mark Kramer, former Director of CDER’s Office of Combination Products.

Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges. Greenleaf’s robust blend of technical skill and FDA institutional knowledge enables the firm to provide reliable, objective guidance to companies developing medical products for the U.S. market.