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.
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.
Woodcock has signaled her support of taking a more flexible approach to drug approvals, leaving some traditionalists aghast. But no matter how people sided in the civil war that divided regulators on Sarepta, there’s no doubt that Woodcock’s already considerable clout at the FDA just grew by several degrees, leaving her in a position to reform the OND on her own terms as the FDA preps for the arrival of Donald Trump at the White House.
The most immediate impact of Jenkins’ departure will be Woodcock’s increased authority at the FDA, says Michael Gaba, the federal policy leader of the firm’s life sciences team at Holland & Knight. But the longterm fallout may have profound implications for the biopharma business.
“There’s an interesting confluence of events taking place that may very well shape the FDA’s future under the next Administration,” he notes in an email message. “I would agree that the Jenkins departure certainly signals a near-term consolidation of Janet Woodcock’s authority at CDER. How that plays out will be a function of who is selected to serve as the next FDA Commissioner.”
But, he adds, if the FDA allows more companies to follow Sarepta’s lead, they could be setting the stage for a damaging erosion of public confidence in the FDA — which the industry benefits from.
“I expect that the opposition expressed by Jenkins and others within the FDA leadership around the Sarepta approval will continue among drug reviewers as they are bound to ensure products are safe and effective for their intended use as supported by scientific data,” Gaba adds. “And I think the drug industry has to be careful here. I can appreciate that any one drug company may want to press its product through with fast track authority when it can, and do so with the help of patient advocates. But as more drug developers are successful in this manner, then the value of an FDA approval could very well be diminished as post-market adverse events increase in the absence of solid up-front end-point based scientific data. This could, over time I suspect, tarnish the FDA’s ‘good housekeeping seal of approval’ that industry as a whole should want to uphold.”
.@chiefcell bigger than that, I think. Does point toward a lower bar at the FDA.
— Matthew Herper (@matthewherper) December 5, 2016
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