FDA’s Janet Woodcock, M.D., recognized by the Institute for Safe Medication Practices: Receives Lifetime Achievement Award for her career in public service

By: Margaret A. Hamburg, M.D.

FDA’s mission is to protect and promote the health of the American public. The FDA employees who dedicate their careers to this worthy goal do so not for personal reward or public recognition but because of an extraordinary commitment to improving public healthcare. Which is why it is even more special when these employees receive public acclaim.

Margaret Hamburg, M.D.

Margaret A. Hamburg, M.D., Commissioner of the Food and Drug Administration

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:

  • 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;
  • 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;
  • Chaired the Council on Pharmaceutical Quality, launched in 2007, presaging many of the Agency’s subsequent safety initiatives;
  • 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—close to “real time”—safety surveillance using electronic data from healthcare information holders;
Janet Woodcock

Janet Woodcock, M.D., Director of FDA’s Center for Drug Evaluation and Research

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

Saluting Dr. Janet Woodcock: an FDA Advocate for Arthritis Sufferers

By: Margaret A. Hamburg, M.D.

Physicians who work at FDA have typically trained in one or more medical specialties — areas of concentration which shape their interests and inform the regulatory work they do here to protect and promote the public health.

Margaret Hamburg, M.D.In my own case, I earned a degree in internal medicine and then focused on infectious diseases, eventually advocating for reforms to confront the dangers of modern bioterrorism, and looking for ways to counter the threat of naturally occurring infectious diseases, such as HIV, pandemic flu, and drug resistant TB.

So, too, it is with the inimitable Janet Woodcock, M.D.

Dr. Woodcock first joined FDA in 1986, and in her years at this agency has served in numerous capacities, including FDA deputy commissioner and chief medical officer. Today, she is director of the agency’s highly-respected Center for Drug Evaluation and Research.

At its recent annual Advocacy Summit, the Arthritis Foundation presented Dr. Woodcock with its Floyd B. Odlum Making a Difference Award, which honors an individual, organization, corporation, or government agency that has helped to make a difference in the lives of people and families with arthritis.

Striking one in every five adults, arthritis is the nation’s leading cause of disability. And it’s not just a disease of old age. Two-thirds of people with arthritis are under the age of 65, including 300,000 children.

Those numbers are not lost on Dr. Woodcock, who began her medical career as a rheumatology specialist, and ever since has been helping to shape and inform the advancement of arthritis treatments.

Dr. Woodcock has been a key figure in the revolution of rheumatoid arthritis therapies, from drugs that broadly address arthritis inflammation to today’s highly-effective, targeted, treatments. She is also helping to shape FDA’s regulatory framework for an abbreviated path to market for biosimilar drugs, those that are shown to be, among other things, highly similar to an already-approved biological product.

Once these drugs become available, they could increase choices for patients and reduce what those patients pay for certain arthritis therapies. Throughout her tenure, Dr. Woodcock has been an active liaison with the rheumatology community, crafting guidance on the development of arthritis medications, partnering on ways to measure a product’s safety and effectiveness, and studying products once they go to market.

In ensuring that safe drugs continue to be developed and become available to the many arthritis sufferers across the country, Dr. Woodcock has remained constant in her dedication to alleviating the pain and suffering of arthritis patients, and so many others. She has insisted upon scientific rigor in the work FDA does.

She has herself said, “I am continually challenged to make sure that FDA’s regulatory process remains the world’s gold standard for drug approval and safety.”

Those who know Dr. Woodcock would agree with me when I say she is a force to be reckoned with. We thank her for that, and along with the Arthritis Foundation, we salute her for all that she does to advance public health.  

Margaret A. Hamburg, M.D., is the Commissioner of the Food and Drug Administration