Addressing the vaping illness
No issue may be more pressing for the FDA than Trump’s looming ban on flavored vaping products, which he announced almost two months ago but has faced considerable resistance from his conservative allies.
The administration is trying to clamp down on skyrocketing teen use of e-cigarettes at the same time it’s grappling with an outbreak of mysterious vaping-related illnesses, largely linked to marijuana, that have sickened nearly 1,900 and claimed more than three dozen lives.
Trump in September pledged harsh new restrictions on flavored vapes, blamed for the uptick in teen use. But the effort has put the FDA into the center of a political tug-of-war, caught between the president’s promised crackdown and vocal resistance from conservative allies and officials in the White House, who worry a crackdown will hurt Trump’s reelection effort.
“Whether Dr. Hahn aggressively tackles e-cigarettes will be one of the defining issues for which he is known,” said Matthew Myers, President of the Campaign for Tobacco Free Kids. “What he does and whether he succeeds in stemming the youth e-cigarette epidemic will inevitably be his legacy.”
As part of his campaign pledge to lower drug prices, Trump at the same time is trying to open the door to importing cheaper drugs from Canada, an arduous undertaking that’s raised a string of FDA-related safety concerns. And though the FDA doesn’t set drug prices, its polices could influence which drugs reach the market and how much competition they face.
The opioid crisis
The federal government is still struggling to contain a drug abuse crisis stemming from years of runaway opioid abuse, though the Trump administration says evidence shows the tide is finally starting to turn. The FDA, meanwhile, has been grappling with the appropriateness of approving new opioids amid the epidemic.
The FDA has traditionally sought leaders with extensive government experience to navigate touchy policy issues and the delicate political relationships that come with it. Trump’s first FDA commissioner, Scott Gottlieb, had a long track record in Washington and won bipartisan praise for his political savvy during his nearly two years running the department.
Hahn has not worked in Washington since leaving the National Cancer Institute nearly a quarter-century ago, and instead climbed the ranks as an academic and hospital administrator at the University of Pennsylvania’s medical school and MD Anderson Cancer Center in Texas. Though a longtime GOP donor, he has largely steered clear of politics, and has no direct ties to a Trump White House that has often stocked its ranks with loyalists.
A departure from Sharpless
But Gottlieb’s handpicked replacement, National Cancer Institute Director Ned Sharpless, faltered on multiple occasions during a seven-month stint as acting commissioner that ended Friday. Most notably, he angered high-profile Senate Republicans and Democrats over his handling of the proposed new limits on tobacco and e-cigarettes.
Sharpless, though well-liked in the cancer research community and among patient advocacy groups, struggled to build political support for FDA’s vaping approach. The Senate’s No. 2 Democrat, Dick Durbin, blasted Sharpless for an “alarming and disappointing” meeting on teen vaping and in September said he should ban e-cigarette flavors or resign.
The episodes convinced the Trump administration that Sharpless would face an uphill confirmation fight if nominated as permanent FDA chief, several sources familiar with the process said.
As this was happening, Hahn was in the running for the top medical job at New York’s Memorial Sloan Kettering Cancer Center — a lucrative role that could have represented the capstone of an acclaimed career as a cancer researcher.
After concluding Sharpless would be a tough sell for the top FDA job, Trump officials focused on luring Hahn away from the potential multimillion-dollar payday at Sloan Kettering. They were convinced that his leadership experience managing a pair of high-profile medical institutions left him equipped to stabilize a sprawling agency that oversees an array of initiatives, ranging from food safety to medical devices and prescription drug regulation.
Hahn is also viewed in the administration as a relatively safe choice whose nomination would be tough for Democrats to stonewall. Hahn is an accomplished oncologist who holds several patents and has taken relatively little money from the drug and medical device industries, unlike past FDA nominees. He also played a key role steadying MD Anderson amid mounting financial losses and the resignation of its president two years ago.
His own kind of political experience
“If you’ve run a large institution like MD Anderson or Penn, the difference between a large research hospital and a government agency is not really that much,” said Scott Whitaker, the CEO of medical device group AdvaMed and a former HHS official in the George W. Bush administration.
Colleagues said his experience at MD Anderson was instructive for how Hahn would approach the FDA job.
“MD Anderson was pretty political in its own internal style,” and he helped navigate it through dicey times, said Thomas Feeley, who worked with Hahn there and is now a professor at Harvard Business School. “I saw him as a very collaborative leader who builds consensus, gains consensus, and when there are difficult decisions to make, has no problem making decisions.”
Administration officials still expect Hahn to face a contentious confirmation hearing before the Senate HELP Committee — just by the nature of the divisive policy issues FDA faces.
Sen. Patty Murray of Washington, the panel’s top Democrat, said in a statement Friday that she will seek assurance Hahn can do the job “without interference from partisanship or ideology,” and that FDA under his watch prioritizes policies rooted in science.
There are also episodes in his record that could get scrutinized.
Democrats are likely to probe his actions at MD Anderson, including his reported defense of the dismissal of several Chinese researchers that some employees viewed as racially motivated. The federal government also cited MD Anderson earlier this year for safety violations tied to a patient who died from a contaminated blood transfusion.
While at the University of Pennsylvania, Hahn apologized to a congressional panel during testimony in 2009 after a doctor under his supervision improperly implanted radioactive seeds into patients, leading to dozens of botched treatments.
Drug pricing position
Policy decisions, however, will likely loom larger in the nomination process. Though drug pricing it outside FDA control, Hahn’s ideas on the topic could draw interest.
In a 2014 paper, he argued for a pricing system that would temporarily limit high prices of new therapies. Republicans typically oppose government dictating drug prices, warning that it would limit research and discovery of new treatments.
He argued for a “trade-off” that could potentially bridge partisan divides: pegging the price of a new drug to its older rivals until evidence of its effectiveness is built and the drugmaker could “reset” prices. It’s not clear whether that idea would be more acceptable to drugmakers or GOP senators, who are resistant to current drug pricing legislation in Congress.
Hahn will also have to face several simmering food policy issues at the agency, which oversees the vast majority of the American food supply. FDA is under pressure to crack down on leafy green safety in the wake of E. coli outbreaks tied to romaine lettuce. Just this week, the agency announced there had been yet another E. coli outbreak likely tied to romaine lettuce this fall — at least the sixth outbreak tied to the product in recent years. The latest episode has been resolved and consumers are not thought to be at risk, the agency said.
Hahn will inherit a nutrition platform largely set by Gottlieb, the former commissioner. Gottlieb surprised many in Washington by hewing closely to the Obama administration’s food agenda, including his decision to keep a major update to the Nutrition Facts labels that appear on billions of packages of food and continuing to work on voluntary targets for reducing salt across the food supply.
Helena Bottemiller Evich contributed to this report.