Regulatory Focus™ > News Articles > 7 > FDA’s OGD Director to Retire in February

FDA’s OGD Director to Retire in February

Posted 17 July 2018 | By Zachary Brennan 

FDA’s OGD Director to Retire in February

After 20 years of service at FDA, Kathleen “Cook” Uhl, director of the US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD), will retire in February 2019.

Center for Drug Evaluation and Research Director Janet Woodcock said in an email to staff: “Though we are sad to see Cook leave CDER, she leaves in place a stronger generics program and an outstanding leadership team.”

Cook joined FDA in 1998 as a CDER medical officer in clinical pharmacology. She has served in several leadership positions since 1998, including assistant commissioner for women’s health and director of FDA’s Office of Women’s Health (OWH) in the Office of the Commissioner. In 2010, she served as deputy director of CDER’s Office of Medical Policy (OMP) and became acting director of OGD in 2013 and permanent director in 2015.

“With a wealth of policy, scientific, and management experience, Cook led both OMP and OGD through major organizational change and expansion as they became ‘Super offices’ – offices that house subordinate offices within their organizational structure,” Woodcock said.

Under Cook’s leadership, Woodcock noted, OGD has raised awareness of the importance of generic drugs, which account for 89% of prescriptions dispensed in the US and generated $253 billion in savings in 2016.

“Cook’s exceptional accomplishments have laid the groundwork for ensuring that the generic drug industry is held to high standards, and for reinforcing our commitment to expedite the availability of safe, effective, and high quality generic drugs. As we conduct a national search to fill Cook’s position, we are committed to maintaining the momentum of the generic drug program. Cook will provide valuable input in the search for her replacement,” Woodcock said.


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.