FDA gains ‘continuity’ as Mikhail, Davis named permanent CBER, CDER leaders

Dive Brief: - The Trump administration on Tuesday installed permanent leaders in two critical Food and Drug Administration positions after a period of turbulence at the agency that unsettled industry leaders and investors. - Michael Davis, the acting director of the Center for Drug Evaluation and Research, will now take on the role permanently, the Health and Human Services Department announced. Likewise, Karim Mikhail will become the full-time director of the Center for Biologics Evaluation and Research after leading the division in an interim role. - The administration also created a new post for Jared Seehafer, who will be the first deputy commissioner for technology and artificial intelligence at the FDA. And Bret Koplow will serve as director of the Center for Tobacco Products. Dive Insight: The second Trump administration has been marked by turmoil at the FDA, a critical agency that regulates products accounting for about a fifth of what Americans spend every year. Mass layoffs, turnover in key positions and what appeared to be erratic decision making left drugmakers frustrated and investors on edge. President Trump’s first FDA commissioner, Marty Makary, resigned in May after a little more than a year in the job. CDER — which had been run by only a handful of industry veterans since its creation in 1987 — had five different leaders last year alone. Davis took over as acting director after the previous interim leader, Tracy Beth Høeg, was fired in May. Meanwhile, former CBER Director Vinay Prasad joined and left the FDA twice over the course of a year, drawing fire for controversial stances on rare disease drugs, vaccines and gene therapies. The person next tapped as acting director, Katherine Szarama, lasted about three weeks before Mikhail stepped in. The selections of Davis and Mikhail to helm the divisions on a permanent basis may offer more of a return to business as usual at the FDA. “The appointment of the current interim directors is likely to be seen as a sign of continuity and stability that should help ease concerns that the FDA will see major shifts in policy,” RBC Capital Markets analyst Brian Abrahams wrote in a note to clients. After the departure of Makary and Prasad, the acting leadership of the FDA largely reverted toward more traditional and flexible decision-making, reversing some positions on previously rejected or delayed drugs. They have also avoided the controversy that marked the Makary-Prasad era. Davis has a range of academic, regulatory and sponsor-side experience that should reassure the biopharmaceutical industry, Abrahams wrote. His special interest in psychedelics may also be a positive for companies such as Eli Lilly looking to bring new products to the market. Mikhail has fewer scientific credentials, but his decades of leadership at both large and small drugmakers and his push for accelerated drug development suggests he will be industry-friendly, Abrahams said. The two appointments are also important as the industry awaits a permanent FDA commissioner. Trump tapped policy aide Heidi Overton for the role in August, but she may face a rocky confirmation. If she does get the job, Overton is likely to be more of a delegator to the division directors, Abrahams wrote. “We do not expect another `larger-than-life’ commissioner looking to remake the agency,” he said.