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.
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