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Trump set to nominate Texas cancer doctor to head FDA

If confirmed, Stephen Hahn would succeed acting commissioner Norman “Ned” Sharpless

President Trump is set to nominate Stephen Hahn, chief medical executive at MD Anderson Cancer Center in Houston, to be the next FDA commissioner. (MD Anderson Cancer Center)
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President Trump is poised to nominate Stephen Hahn, a top official at MD Anderson Cancer Center in Houston, to be the next commissioner of the Food and Drug Administration, according to people familiar with the situation who spoke on the condition of anonymity to share private conversations. The announcement could come as soon as Thursday.

If confirmed, Hahn would head an agency that regulates a broad swath of the U.S. economy, including brand-name and generic drugs, medical devices, much of the nation’s food supply, and tobacco products.

The FDA is currently embroiled in a high-profile controversy over youth vaping and the president’s decision to ban most flavored e-cigarettes. Along with the Centers for Disease Control and Prevention, it is investigating an outbreak of vaping-related lung illnesses and is developing the previously announced e-cigarette ban to try to reduce youth vaping.

Hahn, 59, a radiation oncologist and researcher, is chief medical executive at MD Anderson and is responsible for overseeing medical practice and patient care. He would succeed acting FDA chief Norman “Ned” Sharpless, who was also a major contender for the commissioner’s post. Sharpless, who previously directed the National Cancer Institute, was named acting FDA chief in March, when the previous commissioner, Scott Gottlieb, announced that he was stepping down.

At that time, Health and Human Services Secretary Alex Azar said the administration would conduct a search for a permanent commissioner. Last month, Sharpless won the endorsement of dozens of cancer and other groups and several previous FDA commissioners. Ultimately, Trump turned to Hahn after meeting with him in the Oval Office in early September. Hahn declined a previous request for comment about being considered for the FDA job.

Sharpless’s term as acting commissioner expires Nov. 1. But if Hahn is nominated, Sharpless could stay on at the FDA until Hahn is confirmed by the Senate, which could take months.

A medical and radiation oncologist, Hahn is described by friends and colleagues as an energetic consensus-builder with a disarming, folksy manner. Otis Brawley, a Johns Hopkins oncologist and former chief medical and scientific officer of the American Cancer Society, praised Hahn for his research expertise and his empathy toward patients. Decades ago, the two worked together on AIDS drugs at the National Cancer Institute.

Brawley said he also admired Sharpless, who expressed strong interest in becoming permanent FDA commissioner. Sharpless is an expert on the biology of aging, with strong drug-development experience. “I would not have wanted to pick” between them, Brawley said.

Hahn, after his stint at NCI, joined the University of Pennsylvania in 1996, serving as chair of radiation oncology from 2005 to 2014. He then moved to MD Anderson to become division head of radiation oncology. He has conducted an array of clinical trials, including trials of treating prostate cancer with proton therapy and new ways to combine immunotherapy and radiation.

In 2017, Hahn became chief operating officer at MD Anderson during a tumultuous time of mounting financial losses and staff cuts that culminated in the resignation of then-President Ronald DePinho. Hahn “was thrust into an uncomfortable situation there,” said a former colleague familiar with the situation. “Rome was burning,” he said.

Hahn oversaw the day-to-day operations of the cancer center and earned good reviews for his role in its financial turnaround and the rebuilding of staff morale. The cancer center, which has almost 22,000 employees, has been in the black for the past two fiscal years, senior officials say.

In a 2017 interview with the Cancer Letter, a trade publication, Hahn said many of the cancer center’s financial problems involved its installation of the Epic electronic health records system. “When we did the Epic install, the largest Epic install in the history of Epic — we did a couple things that were sort of the big bang, if you will,” he said. “We did inpatient, we did outpatient, and we did the billing system — all at once. ”

During Hahn’s tenure as chief operating officer, the cancer center also struggled to deal with Hurricane Harvey, which battered Houston in August 2017. The hospital wasn’t flooded but many surrounding roads were impassable.

Hahn confronted another major problem in late December 2018 when a 23-year-old leukemia patient died after being given a blood product contaminated with a rare bacteria. After investigating, the Centers for Medicare and Medicaid Services sharply criticized the hospital for deficiencies in nursing care, patients rights and quality assurance.

In late June, the cancer center released a 94-page “plan of correction” to fix the problems. That included stepped-up monitoring of patients undergoing blood transfusions and a new informed consent process.

The cancer center’s website says Hahn’s expertise is in lung cancer and sarcoma, an uncommon group of cancers that arise in the bones and connective tissue. His research, it adds, “focuses on the molecular causes of the tumor microenvironment, particularly the study of chemical signals that go awry.”

Over the last several years, Hahn, who is a registered Republican, contributed to some GOP campaigns, including Mitt Romney’s 2012 presidential run, and also to a few Democrats’ campaigns. Sharpless, a former director of the University of North Carolina Lineberger Comprehensive Cancer Center who is not registered with either political party, contributed to some Democratic candidates, including the presidential bid of Barack Obama, and to opponents of North Carolina Republican senators Thom Tillis and Richard Burr.

Hahn’s salary for fiscal 2019 was $933,600, and his total compensation was $1.3 million, according to Texas state records. The FDA commissioner makes about $160,000.

Hahn, who is married and has four adult children, is an exercise enthusiast and avid football fan — especially of the San Francisco 49ers, friends say. Hahn did part of his medical training in that city. He and his wife, friends say, travel frequently to Italy.

— Alice Crites contributed to this report.

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