JOHN JENKINS will retire from his job as director of the FDA Office of New Drugs on Jan. 6, 2017.
FDA will conduct a national search to fill his position. Janet Woodcock, director of the Center for Drug Evaluation and Research will serve as acting director of OND.
Announcing Jenkins’s retirement, Woodcock wrote:
For the past 15 years, [Jenkins] has led OND in its difficult tasks of setting the U.S. standards for new drugs’ safety and efficacy, overseeing the clinical testing of investigational drugs, and reviewing marketing applications under PDUFA timelines. He and his staff, which has grown to more than 1,000, have successfully navigated many high-profile controversies related to new drugs—while at the same time having thousands of interactions with industry and other stakeholders, and making timely decisions about INDs and NDAs.
John joined FDA in 1992 as a medical officer in CDER’s former Division of Oncology and Pulmonary Drug Products. He 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.
John is credited for his pivotal role in designing and overseeing our current managed new drug review process, an initiative known as 21st Century Review.
He has also successfully implemented multiple process changes mandated by legislation or initiated through user fee agreements. John has championed the new biosimilars review program, which has been set up within the Office of New Drugs. Additionally, he has created many processes to help ensure consistency of policies and procedures in new drug review, including labeling, pediatrics, and safety requirements. John has set guidance and policy guiding OND staff in meeting FDA’s public health mission in a complex and changing environment. He has been at the forefront of communications with regulated industry during drug development concerning a wide variety of clinical, scientific, and regulatory matters.
John has led OND in approving a notable number of novel drug therapies each year. These include drugs for rare diseases and drugs to treat life-threatening diseases, many of which were approved first in the United States. OND has also approved many new drugs that are additions to an existing class, or offer some symptomatic improvement to a non-serious illness.
Such drugs require careful scrutiny for safety. Other drugs have been successfully switched over-the-counter, improving people’s access to self-care. 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.
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.
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.
