President Donald Trump on Friday announced he intends to nominate Stephen Hahn, a doctor and executive at one of the country’s leading cancer treatment hospitals, to be the next Food and Drug Administration commissioner.
Hahn is currently the chief medical executive at the MD Anderson Cancer Center in Houston. He is trained as a radiation oncologist, a field that uses radiation to kill cancer cells and tumors or slow their growth.
Acting FDA Commissioner Ned Sharpless has led the agency since April. Sharpless had previously led the National Cancer Institute and filled in as FDA head after Scott Gottlieb’s departure. Like Hahn, Sharpless is a cancer doctor and researcher, and had backing from many prominent health and patient groups and several former commissioners, including Gottlieb.
But Sharpless’ history of donating to Democrats in his home state of North Carolina and what’s viewed by some as a clumsy handling of the FDA’s e-cigarette portfolio could have made his confirmation difficult. The Senate’s No. 2 Democrat, Richard J. Durbin of Illinois, called on Sharpless to resign over his handling of e-cigarettes, though he relented after the Trump administration proposed banning all flavored products.
The FDA’s plans for regulating e-cigarettes and implementing a ban on flavored nicotine products are likely to be major issues as Hahn goes through Senate confirmation.
Hahn is not completely without baggage, with two notable episodes that could blemish his resume. Earlier this year, the Centers for Medicare and Medicaid Services said an evaluation at MD Anderson after a patient death caused by contaminated blood platelets found serious lapses in blood transfusion monitoring.
Hahn was also involved in a 2009 episode when Congress and the Department of Veterans Affairs investigated allegations of botched prostate cancer treatments by one of Hahn’s subordinates. But Hahn was one of the officials whose job it was to correct the problems, and the VA inspector general later offered suggestions for improvement and found examples of medical errors, but not wrongdoing.
Hahn has a history of donating to Republican presidential campaigns — though not Trump’s — and in 2017 gave to the political action committee of then-Energy and Commerce Chairman Greg Walden, R-Ore. But on several occasions Hahn, who spent most of his career at the University of Pennsylvania, also gave to former Pennsylvania Democratic Reps. Robert A. Brady and John P. Murtha.
Hahn, 59, attended medical school at Temple University in Philadelphia, and later spent six years as a fellow and resident at the National Cancer Institute of the National Institutes of Health. He is also a researcher with more than 200 articles in peer-reviewed journals.
At the University of Pennsylvania, he rose up the ranks of the medical school’s radiation oncology department, which he chaired from 2005 to 2014.
As the department chair in 2009, he came to Capitol Hill to testify about allegations of shoddy care delivered by one of his employees.
Gary Kao, a Penn doctor working under the university’s contract with the Philadelphia VA, was found to have improperly implanted radiation treatment into 92 of 116 patients that he treated in the early 2000s.
Media reports led to a congressional inquiry, and Hahn testified alongside Kao before the House Veterans Affairs Committee in July 2009.
Hahn was apologetic in his testimony and emphasized steps that his department took to fix the situation. Hahn said that when he became aware of concerns regarding Kao’s implants a year earlier, Kao suspended his practice. The department adopted a new process for patient follow-up and a new reporting system to detect treatment anomalies.
“There are many lessons that we have learned and will continue to learn from this very painful episode,” Hahn said, calling it “unacceptable” even if “it were just one human being who did not receive the best possible care.”
In 2010, a VA inspector general report found that the VA doctors didn’t perform post-implantation dosage studies as quickly or regularly as they should have, and highlighted a medical error that occurred in one of the cases, bud didn’t find evidence of intentional wrongdoing.
Hahn left Penn to run MD Anderson’s radiation oncology department in 2015. In 2017, he became the hospital’s deputy president and chief operating officer and became chief medical executive last year.
MD Anderson, part of the University of Texas system, is considered one of the country’s premier cancer treatment centers. MD Anderson had an operating budget of $5.2 billion in fiscal 2018 — nearly the same as the FDA’s budget — and 1,200 clinical trials were active there that year.
Several treatments with clinical trials conducted in part at MD Anderson were approved by the FDA last year.
MD Anderson is also closely tied to the National Cancer Institute, which Sharpless previously led. It was ranked second nationwide among health systems and universities in the amount of NCI funding it received in 2018.
The violations found by CMS and state officials earlier this year stemmed from surveys after the MD Anderson patient died in 2018 after receiving contaminated blood platelets. The hospital reported the problem to the FDA, which conducted its own review and then referred the case to CMS, according to MD Anderson.
While CMS said the violations were so serious that they “substantially limit” the hospital’s “capacity to render adequate care,” MD Anderson’s reimbursement status wasn’t at risk and CMS didn’t order a corrective action plan.
Karen Bird, executive director of the Alliance of Dedicated Cancer Centers, which advocates for 10 hospitals including MD Anderson that exclusively treat cancer, said that Hahn’s experience makes him well-suited to lead a large organization like the FDA.
Leaders at hospitals like MD Anderson, she said, must juggle twin priorities of patient care and research. While the two are not mutually exclusive, she said that promotions are usually based on research, and a larger share of the center’s revenue comes from research compared to a more traditional hospital.
“They are constantly juggling admissions, research, patient care and the professional academic careers of their faculty,” she said. “They are very political organizations.”