One of NEHI's 2016 Innovators in Health honorees, Dr. Janet Woodcock, says that innovation is a part of everything she does.
NEHI is proud to honor Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA), on September 29th at the NEHI's 2016 Innovators in Health Awards. Dr. Woodcock has had a remarkable 30 year career at the FDA where she’s made countless impacts on the lives of patients and the advancement of science.
Dr. Woodcock went to medical school and was trained as a rheumatologist, thinking that she would practice. Early in her as a physician career, research brought her to the FDA for a short time right as the biotech revolution was beginning, and allowed her to see the importance of making sure that science, medicine, and policy align. And, Dr. Woodcock has been working at the agency ever since.
Dr. Woodcock’s efforts in her role at FDA have helped improve the health of Americans and bring awareness to the importance of drug safety. Her commitment to using innovative solutions and to advancing innovative technologies has been demonstrated throughout this storied career.Dr. Woodcock's efforts to streamline reviews has resulted in the approval of 66 year high of new drug approvals in 2015 (51 new drug approvals), and her commitment to patients have brought more voices to the table than ever before.
As a 2016 Innovator in Health, we asked Dr. Woodcock a couple of questions regarding her achievements in the field of health care:
NEHI: Where have you seen successful innovations in health care?
JW: In my corner of the world (drug development), innovation has led to remarkable improvements in certain diseases. Innovation in new kinds of drugs (biologic therapeutics) have revolutionized treatment of rheumatoid arthritis, other autoimmune diseases and certain cancers. Scientific understanding of how viruses function has led to control of the HIV epidemic, and the cure of many people with Hepatitis C. A wide range of evidence-based interventions have brought down the toll that heart disease was taking on the community. Many people with rare genetic diseases have a better future due to scientific innovation in drug development.
NEHI: Was there a time in your (remarkable!) career where you used or needed innovation to address a health or health care issue?
JW: Regulatory innovation has to keep pace with scientific innovations. The approaches that were successful, even a triumph, many decades ago aren’t always the best fit for current realities. I have ALWAYS needed innovation to get through challenges. For example, for drugs for terrorist threats, the “animal rule” was developed. To respond to urgently needed innovations for people with life-threatening illness, “accelerated approval” was instituted. When we realized data from adults could not just be extrapolated to children, a whole new pediatric development program was crafted over time, including incentives, mandates, and a whole science of how to study children. The biosimilars program is a big innovation. Most recently, the “Breakthrough Therapy” designation program was put into place. This has had a big impact in helping more the new targeted therapies through the system. We clearly need more innovation for antimicrobials, and we have been discussing this.