Scott Gottlieb at Brookings Institution, 19 March 2019 (A. Kotok)
20 Mar. 2019. The commissioner of the Food and Drug Administration warned that the sharp rise in teen electronic cigarette use is an epidemic threatening the public health. Scott Gottlieb made the remarks in an interview yesterday at the Brookings Institution, a public policy think tank in Washington,. D.C.
Gottlieb, in his last few weeks as FDA’s commissioner, used the word “epidemic” several times to describe the recent increases in electronic cigarette use, also known as vaping, among teenagers. Electronic cigarettes, or e-cigarettes, are battery-powered nicotine delivery devices, that heat a liquid containing nicotine, moisturizing and flavoring agents, as well as preservatives and artificial coloring. Makers of e-cigarettes often market the devices as safer alternatives to tobacco-burning cigarettes and sometimes as a technique to help tobacco smokers quit conventional cigarettes.
But findings from the most recent National Youth Tobacco Survey, released in November 2018, show the number of e-cigarette users in high school rose 78 percent to more than 3 million, or about 21 percent of all high school students, since the last survey in 2017. Even among middle school students, e-cigarette smoking jumped by 48 percent in the past year to 570,000 or about 5 percent of all middle school students. The report also shows rising combustible tobacco use among high school and even middle school students, after years of continuous declines.
“All the gains made against youth tobacco use over the years,” noted Gottlieb, “will be reversed by these products.” While acknowledging that some evidence shows e-cigarettes can help current smokers quit their conventional cigarettes, that’s far outweighed by the marked increases in teen use of e-cigarettes and upticks in combustible tobacco. In fact, said Gottlieb, the law requires giving more weight to stopping adolescent smoking. And while tobacco companies agreed to take their flavored products — considered inducements for younger smokers — off the shelves, Gottlieb called a meeting held last week with tobacco company executives “difficult.”
Another difficult issue for FDA was the U.S. government funding impasse and shutdown, which included FDA for much of that period. Gottlieb called the shutdown, “the largest operational challenge in our history,” but has not seen long-term negative effects from it, at least not yet. With a separate funding stream from user fees, FDA was able to keep up its schedule of high-risk inspections, but Gottlieb acknowledged overall inspections were down 5 to 10 percent.
Other questions posed by interviewer Anna Edney, health policy reporter at Bloomberg, included prospects for cannabidiol, or CBD, -based products before FDA. The latest farm bill that passed Congress in December 2018 legalized growing of hemp with low concentrations, less than 0.3 percent, of THC, the high-producing chemical in cannabis. The legislation still puts restrictions on growing non-intoxicating hemp, but CBD from hemp grown under those restrictions is no longer considered a controlled substance. Gottlieb said an agency working group is now reviewing the legislation, but because there are no products with CBD now in the food supply, it will take “highly novel rule-making” to establish a regulatory framework for these products.
One disappointment for Gottlieb is the slow growth in the use of so-called biosimilar therapies. Biosimilars are engineered replacements for original branded biologic drugs, and not one-to-one chemical substitutes like generic drugs. As a result, biosimilars are more complex and must show they are interchangeable with the branded drugs they seek to replace. Gottlieb said biosimilars face headwinds from larger rebates offered by makers of branded biologics, as well as physicians who have more experience with the original biologics. He urged payers and health plans to “take a long view” with biosimilars, and look past the immediate rebates to more price competition that biosimilars can provide.
Gottlieb announced his resignation as FDA commissioner on 5 March because of the long periods of time away from his family, including 3 young children, who live in Connecticut. He said his last day will be 5 April, and feels “very good about the inflection point FDA is at.” Gottlieb added that, “It will be hard to walk away from this job.”
More from Science & Enterprise:
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- FDA Approves 25 Precision Meds in 2018
- Shutdown Delays FDA Peanut Allergy Drug Review
- Start-up Funds Univ. Medical Cannabis Research
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