FDA's new drugs director Jenkins retires, months after criticizing regulator, RAPS reports

After hitting out at the regulator for some of its decisions that led to the recent approval of Sarepta’s DMD med Exondys 51, John Jenkins is retiring from the FDA's office for new drugs next year, with Janet Woodcock set to run the office in the interim.

The decision to retire, reported by Zachary Brennan from RAPS, comes around a quarter of a century after he started working at the regulator.

The current CDER director, Janet Woodcock, said in an email to staff, published by RAPS: “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 will leave his position, where he led the regulatory oversight for investigational tests during drug development and also on marketed meds, on Jan. 6, the news site reports, a few weeks before president elect Donald Trump takes office.

It also comes as the commissioner for the FDA, Robert Califf, is set to hand in his notice (a formal resignation in the light of a new president, although Trump can refuse to accept the resignation).

It also comes after a fairly big falling out among some in the FDA over Exondys 51, where several members, including Jenkins, disagreed with the way the U.S. regulator gave the green light to Sarepta’s med on both light evidence and few patients back in September.

It was in fact Woodcock, who will run the office for new drugs as acting director while looking for a permanent new head, who pushed through Exondys 51 to gain approval, with Califf saying he would defer to her decision.

A month after this decision, at the NORD summit in Arlington, Virginia, Jenkins set out his stall as to why the FDA on his watch wasn’t looking to lower standards, a concern many have voiced since the DMD approval.

He reeled off the regulator's desired data list and what it wants, and doesn't want, to see: “In many cases, randomized controlled clinical trials represent the fastest way to determine if a drug is effective,” and that companies should “randomize as early as possible in development to avoid potentially misleading and uninterpretable findings from open-label trials.”

On the issue of being more flexible, as per Woodcock’s philosophy, he said: “Flexibility in FDA regulations does not mean marketing approval prior to demonstration of substantial evidence of effectiveness.”

He said that the FDA’s use of speedy reviews should be prospectively planned, “NOT as a ‘rescue’ for a failed program.”