John K. Jenkins, M.D., director of the FDA’s Office of New Drugs (OND), will retire from the federal government on January 6, 2017, the agency has confirmed.
Dr. Jenkins played a “pivotal role” in overseeing the FDA’s current managed new drug review process, or “21st Century Review,” Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research (CDER), said yesterday in a memo to Center staffers.
Dr. Woodcock will serve as acting OND director pending a successor to Dr. Jenkins, which she said will emerge following a national search.
In his position, she said, Dr. Jenkins led OND in setting U.S. standards for new drugs’ safety and efficacy, overseeing clinical testing of investigational drugs and reviewing marketing applications under Prescription Drug User Fee Act (PDUFA) timelines.
“He and his staff, which has grown to more than 1000, 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,” Dr. Woodcock said. “John has set guidance and policy guiding OND staff in meeting FDA’s public health mission in a complex and changing environment.”
To that end, Dr. Woodcock said, Dr. Jenkins successfully implemented multiple process changes wrought by legislation or user fee agreements—such as the agency’s biosimilars review program, established within OND, and new processes designed to help ensure consistency of policies and procedures in new drug review, including labeling, pediatrics, and safety requirements.
However, Dr. Jenkins was among FDA administrators who took exception to the agency’s first approval of a Duchenne muscular dystrophy (DMD) treatment—Sarepta Therapeutics’ Exondys 51 (eteplirsen), indicated for DMD amenable to exon 51 skipping—despite recommendations by two advisory committees against approving the treatment.
Dr. Jenkins was among administrators who cited concerns that clinical data was inadequate and did not meet agency requirements for clinical studies: “Path taken by Sarepta NOT a good model for other development programs,” he emphasized during an October 18 presentation at the National Organization for Rare Disorders (NORD) Summit Meeting in Arlington, VA.
However, Dr. Woodcock favored approval of Exondys 51. Parents of boys with DMD argued that neither FDA nor clinical studies had found any safety problems with eteplirsen, and that the drug improved patients’ conditions. Dr. Robert Califf sided with Dr. Woodcock, but later called for retraction of a 2013 clinical study.
Dr. Jenkins joined FDA in 1992 as a medical officer in the 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.
Four years later, Dr. Jenkins was named director of the Office of Drug Evaluation II. He served in that position until he was appointed OND director in January 2002.
Dr. Jenkins’ retirement comes amid uncertainty over whether Dr. Califf will continue at the agency helm. Dr. Califf was nominated by President Barack Obama in September 2015 and confirmed by the Senate in February in a bipartisan 89 to 4 vote.
Dr. Califf is expected to offer his resignation, as is custom when a new president takes office, with President-Elect Donald Trump’s administration to decide on accepting that resignation.
On the Trump transition’s website last month, the President-Elect listed among his administration’s healthcare priorities “Reform the Food and Drug Administration, to put greater focus on the need of patients for new and innovative medical products,” as well as “advance research and development in healthcare.”