A few weeks ago, John Jenkins, the longtime director of the FDA’s Office of New Drugs, caused quite a stir with some advice for biotechs to avoid the same regulatory pathway adopted by Sarepta, the new winner of a controversial FDA approval for Exondys 51 for Duchenne muscular dystrophy.
“Path taken by Sarepta NOT a good model for other development programs,” declared one of Jenkins’ talking points under a final section marked “lessons learned” from eteplirsen and other cases (read “Path Taken by Sarepta NOT a Good Model for Other Rare Drug Approvals, Says FDA Official Who Should Know”; http://sco.lt/7stCs5).
In the future, he noted in his presentation, developers would be held to a high standard when it came to new marketing approvals; Sarepta was the exception that proved the rules. And anyone who thought about following Sarepta’s path at the FDA, he added, was going down the wrong trail.
This morning, though, CDER director and Sarepta champion Janet Woodcock spread the word that Jenkins is retiring from the FDA in early January — and she’s temporarily assuming his position.
“We will conduct a national search to fill John’s position,” Woodcock notes, after a lengthy summary of his work at the agency. “During this time of transition, I will serve as acting director of OND. I will continue to engage in discussions with OND staff and work closely with OND leaders as we work together to address scientific advances that will impact the new drug review program in the coming years.”
Jenkins’ departure comes after a brutal showdown between Woodcock and top officials at the FDA who fought hard against the approval of Exondys 51. Sarepta, its critics say, never came close to providing clear evidence of efficacy and safety for eteplirsen. But in the end Commissioner Robert Califf opted to defer to the powerful Woodcock, overruling the objections and deep split inside the FDA about its role in supervising this approval process.