More change at the FDA as John Jenkins steps down

Director of the FDA’s Office of New Drugs, John Jenkins, will reportedly step down in early January. His retirement comes at a challenging time, as the agency prepares for a political transition.


John Jenkins, director of the Office of New Drugs

John Jenkins will reportedly step down as director of the FDA’s Office of New Drugs (OND) on Jan. 6, 2017, after a year of internal debate at the agency.

The Regulatory Affairs Professionals Society (RAPS) broke the news on Monday, sharing excerpts from an internal email sent to staff by Janet Woodcock, head of the Center for Drug Evaluation and Research (CDER).

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“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.”

After almost 25 years of service, Jenkin’s retirement from the agency is not a complete surprise. But it does come at an interesting time in his career and the overall course of the FDA.

In Dec. 2015, he expressed concerns about priority review vouchers, which obligate the FDA to perform an accelerated review. The vouchers cost hundreds of millions of dollars, but Jenkins argued that the drugs aren’t any safer, and therefore, still require a thorough review.  

Six months ago Jenkins broke ranks again, publicly questioning the application of breakthrough therapy designations. He claimed too many therapies applying for the designation offered just incremental improvements.

The third — and arguably the greatest — controversy in recent times, for Jenkins and the FDA, came with the approval Exondys 51. In Oct. 2016, Jenkin’s spoke out about the decision to approve the rare disease therapy, underscoring why it should not set a new precedent.

“Path taken by Sarepta NOT a good model for other development programs,” Jenkin’s noted in a bullet point slide (emphasis applied in original text).

Despite recent issues, Jenkins has for the most part been a stable OND director — a trait likely to be missed as it enters a period of transition.

In November, Woodcock revealed the agency has more than 700 job vacancies in its drug approval division. Hiring remains tough, as high-paying pharma jobs drain the FDA’s scientific talent pool.

As is custom, commissioner of the FDA Robert Califf is expected to hand his resignation to the incoming President Trump. The resignation could theoretically be rejected, but only one other President has allowed an existing commissioner to continue.

Woodcock is expected to take over from Jenkins on Jan. 6., serving until a new director is officially sworn in.

Photo: Wikimedia Commons