FDA’s Office of New Drugs Director to Retire

Posted 05 December 2016 By Zachary Brennan

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After nearly 25 years of service at the US Food and Drug Administration (FDA), John Jenkins, M.D., Director of the Office of New Drugs (OND), will retire from the federal government on 6 January 2017.

For the past 15 years, Jenkins has led OND in its difficult tasks of setting US standards for new drugs’ safety and efficacy, overseeing the clinical testing of investigational drugs and reviewing marketing applications under Prescription Drug User Fee Act (PDUFA) timelines.

Jenkins oversaw a staff of more than 1,000, navigating many high-profile controversies related to new drugs — while at the same time interacting with industry and other stakeholders.   

Joining FDA in 1992 as a medical officer in the Center for Drug Evaluation and Research’s (CDER) former Division of Oncology and Pulmonary Drug Products, Jenkins later served as pulmonary medical group leader and acting division director before being appointed director of the newly created Division of Pulmonary Drug Products in 1995. In 1999, John was named director of the Office of Drug Evaluation II and served in that position until he was appointed OND director in January 2002. 

More recently, Jenkins offered some criticism of FDA’s breakthrough designation process and the priority review voucher programs.

CDER Director Janet Woodcock praised Jenkins’ work in an email to staff, “As a trusted colleague, John is known and respected for his contributions both inside and outside FDA. He is both brilliant (for example, read his prescient review of NSAID safety, done during the height of that controversy), and steady — a rare combination.”

Jenkins designed and oversaw the current new drug review process, an initiative known as 21st Century Review, and also successfully implemented multiple process changes mandated by legislation or initiated through user fee agreements.

In addition, Jenkins worked to shape the new biosimilars review program, which was built under the umbrella of OND. He also helped to set guidance and policy guiding OND staff in meeting FDA’s public health mission.

“With John at the helm, OND has effectively used various regulatory and scientific tools to ensure safe and efficient development, review, and approval of new therapies — all while maintaining high standards for safety, effectiveness, and quality,” Woodcock wrote this morning.

“He is known for his fair-minded approach to differences, and he has served as a role model for a new generation of reviewers. I have benefitted from his insight and guidance over our many years of working together. His passion for promoting and protecting public health is evident, and he has always stayed focused on the needs of those we serve — patients and the health care community. He has brought CDER’s drug review process, known worldwide as the model of excellence, to where it is today. He will truly be missed here at CDER.”

Moving forward, Woodcock said FDA would conduct a national search to fill Jenkins’ position. During this time of transition, Woodcock said she will serve as acting director of OND.

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Categories: Biologics and biotechnology, Drugs, Orphan products, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, CDER

Tags: John Jenkins, Office of New Drugs, OND, CDER's OND, new drug applications

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