Texas cancer doctor

Trump to pick Texas cancer doctor to head FDA

By SARAH KARLIN-SMITH

President Donald Trump on Friday will nominate Stephen Hahn, a well-regarded cancer specialist and hospital administrator, to lead the FDA, three people familiar with the decision told POLITICO.

If confirmed by the Senate, the top FDA post would mark Hahn's first foray into public service in a quarter of a century. He was chairman of the radiation oncology department at the University of Pennsylvania medical school for nine years until 2015, when he joined MD Anderson Cancer Center in Texas and rose to chief medical executive last year.

His background is a sharp contrast to Trump's first FDA commissioner, Scott Gottlieb, who had a wealth of government experience, including stints at the FDA and CMS in the George W. Bush administration and a long track record of working on health policy issues for Washington interest groups.

Hahn — who emerged as the clear frontrunner for the FDA job in September — was part of the Public Health Service in the early 1990s and served as the chief of the National Cancer Institute's prostate cancer clinic in 1994 and 1995. He has not been in government service for about 25 years.

The Trump administration is expected to announce Hahn’s selection later this afternoon, two sources said, ahead of Friday’s statutory deadline for nominating a permanent commissioner.

Ned Sharpless, who had been the acting FDA commissioner since Gottleib's departure this spring, could only have remained in the position through Friday if Trump didn't nominate a new commissioner. However, the Trump administration instead will temporarily name HHS Assistant Secretary of Health Brett Giroir as the interim FDA chief until Hahn is installed.

HHS declined to comment.

As FDA commissioner, Hahn would oversee a sprawling bureaucracy with a $5.4 billion budget that regulates products that account for about 20 cents of every dollar spent by U.S. consumers. The agency's portfolio ranges far beyond Hahn's experience in drugs and medical devices to food, animal health and tobacco policy. He'll immediately have to address a public health crisis surrounding electronic vaping products and the Trump administration's plans to regulate e-cigarettes.

The politically charged nature of the e-cigarette debate could slow the confirmation process, said Mark McClellan, a former FDA commissioner in the George W. Bush administration. Senators could delay advancing the nomination in order to showcase their concerns over regulations and industries that fall under the agency's jurisdiction.

"In the past there have been holds put on, not for any personal reasons but because there are so many issues that FDA deals with that members have strong feelings about," he said in an interview.

For example, former President Barack Obama's second pick to head the agency, Robert Califf, was held up over concerns about FDA's work on opioids, although lawmakers had no particular objections to Califf's background on the topic.

McClellan said he could envision senators slowing down Hahn's nomination over e-cigarette regulation, regardless whether the concern is FDA isn't moving more aggressively on flavored e-cigarettes targeted at children or if some lawmakers believe FDA is restricting access to products that could, if properly regulated, help reduce smoking.

But McClellan wasn't concerned about Hahn's lack of experience on tobacco policy, saying "there are so many public health issues," on FDA's agenda, any nominee will face "some new challenges" leading the agency.

Those who've worked with Hahn predict he'll rise to the challenge and fill in gaps in his knowledge base.

Hahn's academic experience has prepared him for running a large government agency, said Karen Bird, executive director of the Alliance of Dedicated Cancer Centers, whose membership includes MD Anderson.

"People who don't work at academic medical centers underestimate how complicated they are to navigate, because there are so many interested that are not all aligned in any given day or year," she said. Hahn is a "great politician with a small 'p'," Bird said, able to manage "many stakeholders" and achieve change in complex environments.

Bird said unlike some physicians Hahn is able to easily move from an individual patient situation to thinking about broader health policy. "Physicians like that make great leaders," she said.

The Alliance for a Stronger FDA, which advocates for more government funding for the agency, echoed the importance of Hahn's academic experience.

"Dr. Hahn’s success in academic medicine is being undervalued as a credential for being FDA commissioner," said Steven Grossman, the group's deputy executive director. "Being chosen to lead and then being promoted in that environment requires sustained political acumen and extraordinary interpersonal skills,"

The structure of academic leadership is similar to the environment Hahn will navigate at FDA, Grossman said. "Unlike most organizations — where the leader stands at the top of a largely hierarchical structure — in an academic health center the leader is required to constantly engage and satisfy multiple co-equal fiefdoms who have competing demands. The resemblance to dealing with HHS, OMB, the House and the Senate is unmistakable."

Thomas Feeley, who worked with Hahn at MD Anderson, said Hahn is a "quick study" and "very good problem solver," who would find it easy to get up to speed at FDA. And he believes Hahn would approach the agency from an apolitical perspective.

This could set him up to more easily fill Gottlieb's shoes. The former FDA commissioner won widespread respect from Republicans and Democrats, despite the highly polarized political climate.

"I don't think he is a political person. I don't think he is pro-Trump or anti-Trump. I think he is pro-patient, pro-consumer," Feeley, now a professor at Harvard Business School, said of Hahn. Feeley described Hahn as a "clinician scientist who happens to be a really astute administrator," and says he doesn't think Hahn would "let politics get in the way of doing the right thing."

Hahn is a longtime GOP donor, according to FEC records, and contributed to Republican presidential campaigns at least as far back to George W. Bush’s 2004 presidential run.

Unlike some past FDA commissioners, he has accepted relatively little money from the drug and medical device industries. According to a Medicare database tracking industry contributions to doctors, Hahn received roughly $1,000 in travel and lodging fees from radiation oncology device company Varian Medical Systems in 2017.

Those qualities helped boost Hahn’s candidacy, as administration officials sought a non-controversial pick who could quickly clear the Senate.

Giroir, the incoming interim FDA head, is well-liked by HHS Secretary Alex Azar, and has taken on increasing responsibility since joining the administration in 2017. He was a central player in the rollout of Trump’s high-profile bid to end new HIV transmissions in a decade, and has served as HHS‘ point person in its efforts to combat the opioid epidemic.