Janet Woodcock, MD, Director of the U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research, has been awarded the Institute for Safe Medication Practices Lifetime Achievement Award, which recognizes “an individual who has had a significant career history of making ongoing contributions to patient safety and has had a major impact on safe medication practices.”
A Distinguished Career
During her nearly 30-year career with the FDA, she has served in several different capacities in addition to her current position, including Director of the Office of Therapeutics Research and Review in the Center for Biologics Evaluation and Research and as the FDA’s Deputy Commissioner and Chief Medical Officer. Throughout her career, Dr. Woodcock has helped the Agency elevate and transform its approach to medical product safety, personally leading the way on many key safety initiatives from their beginning to implementation.
During her career, Dr. Woodcock:
- Conceived and oversaw the creation of the Adverse Event Reporting System, to manage the increasing number of spontaneous reports of adverse drug reactions submitted to the FDA
- Co-led the FDA Task Force on Risk Management, one of the Agency’s first efforts to delineate premarket and postmarket safety surveillance and management of medical product risks;
- Chaired the Council on Pharmaceutical Quality, launched in 2007
- Led the rollout of the Safe Use Initiative, to reduce preventable harms related to drug use
- Led the launch of Safety First, a program created to help ensure alignment between premarket drug safety review and postmarket surveillance
- Led the creation of the Sentinel Initiative, a data-driven national system that allows active safety surveillance using electronic data from health-care information holders
- Launched the new Office of Pharmaceutical Quality and served initially as its Acting Director
“Through all of these accomplishments, and many others, Janet Woodcock has helped ensure that the FDA can fulfill its mission effectively,” stated FDA Commissioner Margaret A. Hamburg, MD. “She has championed the use of innovative new tools and approaches and has forged and enriched many partnerships with industry, academia, health-care providers, patients, and colleagues in government, including across the FDA.” ■
