When President Donald Trump’s nominee to lead the Food and Drug Administration appears for the first time before a Senate panel on Wednesday, he’ll likely face tough questions about some policy issues that he may not have thought much about previously.
While the nominee, Stephen Hahn, is a highly regarded cancer doctor who has helped lead a research hospital with a budget nearly the size of the FDA’s, the confirmation hearing will be a reminder of the breadth of the agency’s work.
Hahn is likely fluent in the language of drug development, but members of the Health, Education, Labor and Pensions Committee queried by CQ Roll Call have more specific issues they want the FDA to address, such as e-cigarettes, agency staffing and food-related issues.
Republican members who met with Hahn described their meetings in positive terms, and HELP Chairman Lamar Alexander, R-Tennessee, said he plans to support the nomination. Even Sen. Richard M. Burr, R-North Carolina, one of the Senate’s biggest FDA critics, said his meeting with Hahn went “very well” and called him “eminently qualified.”
Democrats may be harder to win over, particularly because of a pending Trump administration decision on e-cigarettes that Hahn had nothing to do with.
In a Nov. 13 hearing, members of the same panel grew deeply frustrated with the head of the FDA’s tobacco division, who declined to clarify the fate of a flavored e-cigarette ban announced in a September press release but still not yet publicly revealed in detailed policy documents.
“That was shocking to me,” panel member Tim Kaine, D-Virginia, told reporters after the hearing.
Democrats will likely press Hahn to say whether he agrees whether the ban should exclude menthol-flavored products and vape shops that cater to adults, as the administration has started hinting it might do in revisions to the policy.
“I think the flavor ban that the administration announced, which is banning flavors unless or until they meet the FDA approval process, I think that’s smart,” Kaine said.
Members from both parties are frustrated that the FDA has had authority to regulate tobacco products for 10 years but for most of that time has allowed e-cigarettes to be sold with barely any regulatory guidance for industry or oversight to help consumers.
“It’s time for the FDA to exercise more of the authority it already has,” Alexander told reporters, such as reducing the amount of nicotine in e-cigarettes and putting warning labels directly on vaping devices.
Alexander also wants to see Hahn implement authorities granted to the FDA under one of his signature efforts, a 2016 law meant to accelerate medical product development.
“We gave them an extraordinary authority to pay government employees a higher salary so we could attract more talented people to FDA to review the applications,” Alexander said, noting that he’d like to see the FDA “do a better job” with that.
Sen. Patty Murray of Washington, the panel’s top Democrat, said when Hahn’s nomination was announced that she would want to see that he is committed to “prioritizing science” and upholding the FDA’s “gold standard for product safety and effectiveness.”
Yet amid a broader discourse about health costs, some Republicans say the FDA’s oversight contributes to high prices and stands in the way of patients accessing cures.
Sen. Mike Braun, R-Indiana, an outspoken critic of the health care industry, says drugmakers have “got kind of a co-conspirator in the FDA, to where it’s largely benefited the industry and not consumers.”
The FDA, he told CQ Roll Call, “needs to be more nimble, it needs to be more entrepreneurial in where it is going to help get things through more quickly and still have the vigilance that should be inherent.” He said he would be looking for ideas about how the FDA can address issues that could lead to lower costs.
Other panel members have more specific drug development priorities they may raise with Hahn. Sens. Johnny Isakson, R-Georgia, and Bob Casey, D-Pennsylvania, could use the confirmation hearing to push for a long-stalled bill that would speed the approval process for over-the-counter drugs and provide the FDA with new fees in exchange.
The pair is also teaming up on a bill to help bolster development of new antibiotics to treat bacteria that are resistant to current treatment. More than 2.8 million antibiotic-resistant infections occur in the United States each year, and more than 35,000 people die, a higher number than previously known, according to Centers for Disease Control and Prevention data released last week.
Sen. Susan Collins, R-Maine, told CQ Roll Call that she is concerned about drug shortages, which she raised in her meeting with Hahn. She wrote a bill with fellow panel member Tina Smith, D-Minnesota, that would allow the FDA to expedite the review of drugs in shortage and require contingency manufacturing plans from companies that make certain essential medicines.
Food and CBD
The previous confirmed FDA commissioner, Scott Gottlieb, had a relatively smooth Senate process and was sworn in around two months after being nominated. He says that this time around there may be more holds on the nomination — including by Republicans.
“There will be issues where there will be members of Congress on the Republican side who might want to see these certain positions or advance certain policies and use that as a vehicle to help effect that,” he said at an event in October hosted by the groups Prevision Policy and Friends of Cancer Research.
He went through a list of issues that members want the FDA to address, some new and some perennial headaches for the agency. Among them were genetically-engineered fish, lab-grown meat and CBD.
Sen. Lisa Murkowski, R-Alaska, is a major critic of the FDA’s 2015 decision to approve the sale of genetically engineered salmon, which could threaten her state’s large salmon-fishing industry. In the years since, she has worked through the appropriations process to impose new labeling requirements that delayed the salmon’s sale in the U.S. But in March, with a label policy in place, the FDA gave the salmon the green light for sales. Murkowski said the labeling requirements aren’t good enough.
Similarly, senators from Western ranching states are worried about how the FDA will oversee the process of growing meat cells in labs.
Gottlieb also predicted cannabidiol, or CBD, would be an issue. CBD is a component of marijuana and hemp plants, and is thought to have therapeutic properties. Ever since hemp was legalized in the 2018 farm bill, the makers of dietary supplements, cosmetics and some foods have embraced products with hemp-derived CBD.
The FDA has been trying to come up with a regulatory framework for CBD, but it’s complicated because it has never faced a product that could be regulated as either a food or a drug. Lawmakers are open to providing extra money for the FDA to develop a CBD policy, but they want it quickly.