MD Anderson official emerges as top choice to run FDA, reports say

Dive Brief:

President Donald Trump is weighing nominating a top executive at the MD Anderson Cancer Center as the next Food and Drug Administration Commissioner, according to multiple reports indicating the Texas oncologist, Stephen Hahn, has become a frontrunner for the post.

Picking Hahn, or a third candidate said to be in the running, would be a change of course from acting FDA Commissioner Ned Sharpless, the former National Cancer Institute director who replaced Scott Gottlieb as agency chief in March.

Four former FDA commissioners this week penned a letter to President Trump and Health and Human Services Secretary Alex Azar supporting Sharpless as the best choice to lead the FDA. "He has gained the respect of the agency staff and a broad spectrum of the public in support of the FDA's mission," the former commissioners, who included Robert Califf and Margaret Hamburg, wrote in their letter.

Dive Insight:

Sharpless, who previously led the National Cancer Institute, is well regarded within the agency and was seen by industry as upholding a regulatory status quo that's blended more flexible drug reviews with traditional standards of safety and efficacy.

In their letter, the former FDA commissioners highlighted the continuity Sharpless offers with the FDA's agenda under Gottlieb.

"The agency is in the midst of many important initiatives begun under former Commissioner Gottlieb, and Dr. Sharpless' expertise will enable new activities in such key areas as cancer treatment and prevention, and precision medicine." Gottlieb did not join the letter, which was also signed by former agency chiefs Andrew C. von Eschenbach and Mark McClellan, but did voice support for Sharpless on Twitter.

Under federal rules, Sharpless can't serve on an acting basis in a Senate-confirmed position longer than 210 days after the role becomes vacant — a clock that runs out Nov. 1.

Sharpless is still under consideration for the permanent role but recently Hahn, chief medical executive at the University of Texas MD Anderson Cancer Center, has emerged as a favorite, according to reports by The Wall Street Journal and Politico.

Hahn has been at MD Anderson since 2015, when he joined as chair of the center's radiation oncology department. Before that, he was a department chair and director of research at the University of Pennsylvania's School of Medicine and worked at the National Cancer Institute in the early 1990s.

Missing from his resume, however, is the regulatory or agency experience usually sought for FDA chiefs.

"I don't know Dr. Hahn, but his reputation is good and he appears to be a good leader and administrator," said Califf in an email to BioPharma Dive.

"However, it takes a while to get to know how the FDA works," he added. "Most importantly, this will be disruptive to the agency and I am concerned that agency functions could suffer."

Also under consideration for the permanent post is Alexa Boer Kimball, a professor at Harvard, The Wall Street Journal reported.

However, Hahn appears to be the only candidate to have met with President Trump directly, according to Politico. Ned Pagialuro