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.
Facts Only
* Michael Davis was installed as the permanent director of the Center for Drug Evaluation and Research.
* Karim Mikhail became the full-time director of the Center for Biologics Evaluation and Research.
* Jared Seehafer was created as the first deputy commissioner for technology and artificial intelligence at the FDA.
* Bret Koplow served as director of the Center for Tobacco Products.
* Michael Davis assumed the role of acting director after Tracy Beth Høeg was fired in May.
* Karim Mikhail became the full-time director after leading the division in an interim role.
* President Trump's first FDA commissioner, Marty Makary, resigned in May.
* Former CBER Director Vinay Prasad joined and left the FDA twice over a year.
* Katherine Szarama served as acting director before Karim Mikhail stepped in.
* The period preceding these appointments was marked by mass layoffs, turnover in key positions, and perceived erratic decision-making at the FDA.
Executive Summary
The Trump administration installed permanent leadership in two critical Food and Drug Administration positions following recent turbulence that unsettled industry leaders and investors. Michael Davis was appointed permanent director of the Center for Drug Evaluation and Research, succeeding an interim role after previous leaders departed. Karim Mikhail was appointed full-time director of the Center for Biologics Evaluation and Research, having led the division in an interim capacity. Additionally, Jared Seehafer was named the first deputy commissioner for technology and artificial intelligence at the FDA, and Bret Koplow became director of the Center for Tobacco Products.
This reshuffling occurred amidst a period marked by instability at the FDA, characterized by mass layoffs, turnover in key roles, and perceived erratic decision-making, which caused frustration among drugmakers and investors. Prior leadership transitions involved resignations and short tenures; for example, Marty Makary resigned after a year, and Vinay Prasad served multiple stints. The appointments of Davis and Mikhail are viewed by some analysts as potentially restoring stability and continuity within the agency.
The new appointments are framed by industry observers as offering reassurance regarding future policy shifts. Analysts suggest that the interim appointments signal a move toward more traditional decision-making, reversing some previous actions related to drug approvals, which may ease concerns about major regulatory volatility. The selections of Davis and Mikhail are also significant as the industry awaits a permanent FDA commissioner.
Full Take
The revolving door of leadership within the FDA, marked by multiple transitions and departures of high-profile figures like Makary and Prasad, suggests a systemic tension between internal operational flux and external expectations for regulatory stability. The appointments of Davis and Mikhail reflect an attempt to reestablish a predictable structure, suggesting that industry concerns about policy shifts might be mitigated by continuity in leadership rather than radical change. The differing profiles of the new appointees—Davis with broad experience and Mikhail with specific industry leadership experience—suggest a balancing act between regulatory adherence and industry-friendly development, as noted by analysts.
The pattern observed is a reactive stabilization strategy following demonstrable turmoil. When faced with volatility, the response shifts toward appointing figures perceived to ensure operational continuity rather than enacting sweeping ideological changes. This raises the question of whether this approach truly addresses underlying structural issues or merely manages external perception. The reliance on experience, as highlighted by the reassurances regarding Davis's and Mikhail's backgrounds, underscores a persistent dynamic where industry stakeholders seek assurance that regulatory processes will remain insulated from transient political influences.
What are the long-term consequences for internal agency culture when leadership changes occur in response to instability? Does prioritizing 'business as usual' successfully insulate the agency from deeper structural critiques regarding its mandate? Furthermore, how do the specific competencies of the appointees—regulatory depth versus industry advocacy—impact the actual functioning and perception of the FDA moving forward?