Dr. Kathleen Uhl
Department of Health and Human Services
The importance of safe and effective generic drugs touches nearly every American household. Generic drugs embody the public health goals of quality, accessibility, affordability, and equity. They are a vital component of reducing health care costs, a fundamental goal of the Department of Health and Human Services (HHS) and the Administration. Most importantly, generics make it possible for millions of Americans to access essential medications.
Dr. Kathleen Uhl pioneered the transformation of generic drug regulation, improving availability and acceptance of generics that have the same high quality as brand-name counterparts. During her six years as Director of the Food and Drug Administration’s (FDA) Office of Generic Drugs, Dr. Uhl led dramatic improvements in the generic drug review process. She and her highly dedicated and talented staff integrated rigorous cutting-edge science, increased safety surveillance, and incorporated the expertise of clinicians and patients. Within three years of Dr. Uhl’s appointment, FDA increased approvals of high-quality generics from 10 to 85-90 per month and resolved a backlog of over 5,000 applications for generic drug approvals, all while maintaining FDA’s stringent criteria for quality and equivalence with brand-name products. In fiscal year 2017, FDA approved 971 generic drug applications of which 19 percent were for first generics, paving the way to make these products more affordable for patients.
The significance of generic drugs cannot be overstated. They provide affordable access to treatment. Patients depend on FDA to ensure that generic drugs perform clinically in the same way as their brand name counterparts. Dr. Uhl has been instrumental in raising awareness of the importance of generic drugs to public health and our national economy and to boosting confidence in and acceptance of generics.” – Norman E. Sharpless, MD, Acting Commissioner of Food and Drugs
Kathleen Uhl’s distinguished Federal career also includes serving as an officer in the U.S. Army and the U.S. Public Health Service Commissioned Corps. Following fellowships at the Walter Reed Army Institute of Research and the Uniformed Services University, Dr. Uhl served as Assistant Commissioner of Women’s Health and Director of FDA’s Office of Women’s Health. Her publications on the significance of sex differences in drug effects contributed significantly to the value now placed on ensuring that drug trials include diverse populations.
“Dr. Uhl’s unwavering dedication to enhancing and protecting the health and well-being of all Americans personifies the HHS mission. She is a scientist, a clinician, and a humanist who always places the well-being of patients first and foremost. Her exceptional accomplishments laid the groundwork for ensuring that the generic drug industry is held to the highest standards, and for reinforcing FDA’s commitment to expedite the availability of safe, effective, and high-quality generic drugs. Dr. Kathleen Uhl has positively impacted the public health of Americans for generations to come.” – Janet Woodcock, MD, Director, FDA Center for Drug Evaluation and Research