publication date: Sep. 6, 2019

MD Anderson’s Stephen Hahn emerges as candidate for FDA commissioner’s job

By Paul Goldberg

The game of musical chairs involving topmost jobs in oncology has gathered speed and expanded beyond FDA and NCI, pulling in premier positions at MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center.

The following chairs appear to be in play: FDA commissioner, NCI director, chief medical executive at MD Anderson, and, until recently, physician-in-chief at MSK.

Let’s slow down the moving spheres and take a closer look:

On Nov. 1, Norman “Ned” Sharpless will have served as an acting FDA commissioner for 210 days, which means that if President Donald Trump wants him to stay at the agency, he should get the nomination process going right now.

If the president doesn’t nominate him, Sharpless might return to his former job as NCI director, once again displacing Acting Director Douglas Lowy, one of the institute’s most respected scientists who is getting his turn at the wheel.

Sharpless is liked in town. Earlier this week, on Sept. 3, 56 cancer groups and four former FDA commissioners in letters to President Trump and HHS Secretary Alex Azar urged the administration to nominate Sharpless, a respected scientist and physician, to the top job at the agency.

The letter from the cancer groups is posted here.

The letter from past FDA commissioners is posted here.

The next day, late on Sept. 4, The Wall Street Journal reported that Stephen M. Hahn, MD Anderson’s chief medical executive and a professor at the Department of Radiation Oncology, has emerged as the leading candidate for the FDA job.

If Hahn gets picked over Sharpless, he would need to go through a two-to-three-month clearance process and, after that, confirmation by the Senate. That would leave him less than a year to serve as commissioner before the end of Trump’s presidential term.

Hahn has apparently had a meeting with President Trump Sept. 4.

Separately, Hahn was believed to be one of the three finalists for the job of physician-in-chief at Memorial Sloan Kettering Cancer Center. The institution hasn’t announced the list, but the hallway conversation at the cancer center, as conveyed by multiple insiders, uniformly identifies Hahn and two others. A source familiar with the situation told The Cancer Letter that Hahn earlier this week withdrew his candidacy for the MSK job.

Hahn’s appearance as a potential alternative to Sharpless came as a shock to Washington insiders. Early this summer, sources who keep a close eye on the White House and FDA started to hear that Sharpless isn’t necessarily a shoo-in for the job of commissioner and that his candidacy is running into opposition from HHS Secretary Alex Azar. (There seems to be no problem at the White House, insiders say.)

Several names of alternative candidates were floated. Also mentioned was a “candidate from MD Anderson.”

Several members of the press devoted some effort to guessing the identity of the dark horse candidate from Houston.

These efforts were half-hearted, at least on the part of this reporter, because Sharpless, 52, is experienced in drug development, conversant in an astonishingly broad range of science, including regulatory science, whip-smart, divested, background-checked, appropriately amused by having accepted a catastrophic pay cut vs. his previous job (more on that later), learning fast in one of the least manageable jobs in the federal government, not a political hack, not a libertarian, and not a jerk. Sharpless was hand-picked and enthusiastically endorsed by his predecessor, Scott Gottlieb, whose name is still good in Washington, in public health circles, and in the pharma industry (The Cancer Letter, March 15).

This reporter ventured a guess or two about the identity of the MD Anderson stranger, but, since Hahn isn’t a drug developer, a regulatory scientist or a politician, ended up way off-mark.

Hahn, a radiation oncologist, stepped in as MD Anderson chief operating officer at the end of Ronald DePinho’s stint as president of the Houston-based institution. His task initially was to quell the disaffection among the faculty and manage the process of transition to new leadership (The Cancer Letter, March 3, 2017).

Though Hahn, 59, isn’t an obvious choice for FDA, no one questions his qualifications for the job. The bigger question is, why would he be any better than Sharpless, and how much time would he have to actually perform his duties—i.e. not only how much sense this appointment would make for the Trump administration, but how much sense it would make for FDA, the regulated industry?

Neither Hahn nor Sharpless responded to requests for comment. Insiders say that Alexa Boer Kimball, a Harvard dermatologist and Brett Giroir, assistant HHS secretary, are no longer viewed as contenders for the FDA job.

“Ned Sharpless is imminently qualified and has gotten to know the FDA. He is a good choice,” Robert Califf, former FDA commissioner and the Donald F. Fortin, M.D., Professor of Cardiology, in the Duke University School of Medicine, said to The Cancer Letter. “I don’t know Dr. Hahn, but his reputation is good and he appears to be a good leader and administrator. 

“However, it takes a while to get to know how the FDA works, and I’m not sure he’s had significant interaction with regulated medical products or food safety. We have an election coming up soon, so it seems like a risky thing for him to consider,” Califf said. “Most importantly, this will be disruptive to the agency and I am concerned that agency functions could suffer.”

Califf is one of the four past commissioners who signed a letter in support of Sharpless’s candidacy. Other past commissioners who signed the letter are Margaret Hamburg, Andrew von Eschenbach and Mark McClellan.

Optimistically, it takes six months or so to get a real understanding of the job, past commissioners say. And then there is the question of pay. As NCI director, Sharpless earned $375,000 a year, which roughly matched his earnings as director of UNC Lineberger Comprehensive Cancer Center. As an acting FDA commissioner, he earns $155,500, federal disclosures show.

Hahn’s most recently reported compensation at MD Anderson added up to $1.3 million. According to tax filings, Jose Baselga, the man Hahn sought to succeed, received just under $2.7 million from MSK and related entities in 2017.

Neither Sharpless nor Hahn have given extensively to political causes.

Federal Election Commission records show that Sharpless has made campaign contributions to Democrats, including a $250 contribution to the Obama-Biden ticket in 2008 and a $500 contribution to the Obama Victory Fund in 2012. Sharpless’s connection to the White House—and his appointment to the job of NCI director—came through Ronald DePinho, his lab chief at Harvard (The Cancer Letter, June 16, 2017).

Most of Hahn’s political contributions were made to radiology and radiation oncology societies. Hahn contributed $250 to Rep. John Murtha, a Pennsylvania Democrat in 2008, $206 to Republican Mitt Romney’s campaign in 2012, and in 2017, he gave $1,000 to New Pioneers PAC, a Republican group.

Hahn’s connection to the administration isn’t publicly known.

Copyright (c) 2019 The Cancer Letter Inc.