#parents | #teensvaping | New FDA chief vows tougher action on youth vaping if needed

Stephen Hahn, the new head of the Food and Drug Administration, defended the Trump administration’s impending partial e-cigarette ban, which has been sharply criticized by Democratic lawmakers and public health groups as too weak. But he also vowed to take tougher steps if needed to reduce teen vaping.

The administration vaping plan, which will take effect Feb. 6, bars sales of most flavored cartridge-based e-cigarettes. Menthol- and tobacco-flavored pods won’t be affected, nor will single-use disposable vapes or bottled e-liquids for the open-tank systems typically sold in vape shops. Those exemptions mean young people will be able to simply switch to products that remain on the shelves, critics predict.

Hahn, who was confirmed in mid-December, disagreed, saying in an interview that the sales restrictions will target the products most popular with young people. But the FDA will closely monitor the situation and if minors do switch to menthol-flavored vapes or other e-cigarette products, the agency will take further action to curb vaping, he said.

“The good thing about this policy is we have the ability without jumping through a lot of hoops to change our enforcement prioritization based on the data we are getting in,” he said in an interview, his first with a national media outlet since his confirmation.

Hahn, an oncologist who was a top official at MD Anderson Cancer Center in Houston, also outlined his priorities as commissioner. He described them as “unleashing the power of data,”https://www.houstonchronicle.com/”empowering consumers and patients” and “promoting choice and competition through innovation.”

On vaping, advocates on both sides expressed skepticism that the FDA would be able to quickly assess and respond to changing patterns in youth use – especially given the drawn-out internal debate that led to the current administration policy.

“The agency’s record of monitoring the marketplace in real time is troubling,” said Matthew Myers, president of Campaign for Tobacco-Free Kids. “There have been enormous changes with no evidence of their knowing it.”

Paul Blair, director of strategic initiatives for Americans for Tax Reform, a limited-government group which has taken a pro-vaping position, said, “There is zero percent chance the FDA can quickly respond to what they view as the risks associated with vaping because in three years they have failed to implement sensible regulations.”

The new commissioner takes the helm of the FDA at a critical time. Besides imposing the partial vaping ban next week, the agency in May will begin a broader look at e-cigarette products to decide which will permanently be cleared for sale. The agency also is under pressure to come up with a regulatory scheme for products containing cannabidiol, or CBD, and to curb stem cell clinics offering unapproved treatments.

The FDA also is at the center of a heated debate over drug approvals, with critics saying the agency is clearing some high-cost therapies on weaker evidence than it has used in the past – an idea Hahn disputed. “We have not changed our standard for approval” on safety and efficacy, he insisted.

But he added the agency must balance those standards with the need to approve new drugs and devices as quickly as possible for people with unmet medical needs. He stressed the importance of companies’ filing timely post-approval studies to increase the understanding of their products. “We do very much value a vigorous post-market assessment,” he said.

The unprecedented amount and complexity of data gives the agency an important tool to improve decision-making for everything from drug approvals to food safety, Hahn said. But the FDA has to find “novel” ways to analyze the data to get the best use out of it, he said.

To empower consumers and patients, he said the FDA must provide more information on subjects of broad interest to the public, including nutrition and drug interactions and side effects. Citing a topic of intense consumer interest, he said the agency is still working on how to regulate CBD, while taking a close look at safety concerns, including potential liver damage.

Echoing former FDA commissioner Scott Gottlieb, Hahn said the agency would continue its efforts to approve additional generic drugs and biosimilars, which are biological medications that work in the same way as previously approved drugs, with the goal of increasing competition and easing drug prices. He said the agency also is looking at post-approval barriers to entering the market.

Hahn, 60, has spent much of his life shuttling between Pennsylvania and Texas. He grew up in a Philadelphia suburb wanting to be a fireman. He later switched to science, graduating from Rice University in Houston and Temple University’s medical school in Philadelphia. He trained as both a medical and radiation oncologist and worked at the National Cancer Institute and the University of Pennsylvania.

His specialty was treating lung cancer and sarcoma, a cancer that begins in the bones and the connective tissues. At MD Anderson, he was chief medical executive, helping to engineer the hospital’s turnaround when it got into financial trouble a few years ago.

A new grandfather, Hahn is known as a fitness fanatic who frequently rises at 4 a.m. to exercise.


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