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One such individual is Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research (CDER). Janet recently was awarded the Institute for Safe Medication Practices (ISMP) Lifetime Achievement Award, recognizing “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.” This award is well deserved.
During her nearly 30 year career with 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 (CBER) and as 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 distinguished career Dr. Woodcock:
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Conceived and oversaw creation of the Adverse Event Reporting System (AERS) system, to manage the increasing number of spontaneous reports of adverse drug reactions submitted to FDA;
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Co-led the FDA Task Force on Risk Management, one of the Agency’s first efforts to clearly delineate pre- and postmarket safety surveillance and management of medical product risks;
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Chaired the Council on Pharmaceutical Quality, launched in 2007, presaging many of the Agency’s subsequent safety initiatives;
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Led the rollout of the Safe Use Initiative, to reduce preventable harms related to drug use;
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Led the launch of Safety First, a program created to help ensure alignment between premarket drug safety review and postmarket surveillance;
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Led the creation of the Sentinel Initiative, a data-driven national system that allows active—close to “real time”—safety surveillance using electronic data from healthcare information holders;
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And, beginning next month, Dr. Woodcock will launch the new Office of Pharmaceutical Quality (OPQ), and serve initially as its acting director.
Through all of these accomplishments, and many others, Janet Woodcock has helped ensure that FDA can fulfill its mission effectively. She has championed the use of innovative new tools and approaches, and she has forged and enriched many partnerships with industry, academia, healthcare providers, patients and colleagues in government, including across the FDA.
Her work has helped lead FDA into a new century, an extraordinary time of transformation and opportunity in medical science. With these changes, FDA’s responsibilities have also grown enormously. We must continue to ensure that our capabilities for drug product evaluation, oversight, and regulation keep pace with these developments. Thanks to Janet’s vision and hard work, along with many of her colleagues at FDA, I am confident that FDA is up to the task.
I want to thank Dr. Woodcock for her years of dedicated service to the American public, and congratulate her on this most recent recognition of her many contributions.
Margaret A. Hamburg, M.D., is Commissioner of the Food and Drug Administration
