E-cigarettes may pose less risks than combustible tobacco, and may provide a “viable alternative,” for adults, but adult access to such products will be reined in if the number of kids using e-cigarettes continues to climb, according to FDA Commissioner Scott Gottlieb, MD.
“We’re going to have to step in … We can’t just addict a whole generation of young people on nicotine with e-cigarettes and consider that a public health advance,” Gottlieb said Tuesday to a subcommittee of the House Committee on Appropriations. “We’ll be taking some very vigorous enforcement steps … starting in the coming weeks.”
During the hearing on the FDA budget, subcommittee members stressed that the agency must act quickly to stop kids and teenagers from using e-cigarettes.
Rep. Nita Lowey (D-N.Y.), the top Democrat for the full Committee on Appropriations, raised a small rectangular device in her hand and said “Commissioner Gottlieb, what does this look like to you?”
Gottlieb said he said he knew what the device was, but played along. “It looks like a USB key,” he said.
“This is a JUUL, which is now among the most popular e-cigarette on the market … One JUUL pod, like this, contains as much nicotine as an entire pack of cigarettes,” Lowey stated.
She applauded the FDA for its work in reducing nicotine levels in cigarettes, but criticized the agency for its “silence” on e-cigarettes, saying it could “open the gates to the next public health emergency.”
Lowey also argued that “kid-friendly” flavors of e-cigarettes, such as mango and cucumber, had been introduced in apparent violation of FDA’s deeming rule, which blocks new e-cigarettes from entering the market after Aug. 8, 2016, without a premarket review from the FDA.
Asked whether JUUL had submitted an application for the new flavors, Gottlieb did not directly answer, saying that he did not want to “telegraph coming enforcement action.”
The FDA does have authority over e-cigarettes to inspect the products, impose good manufacturing practice standards, and enforce age restrictions, he noted.
He reiterated that the agency would be “stepping into this fight in a vigorous way in the coming weeks.”
On Wednesday, six leading public health and medical organizations, including the American Academy of Pediatrics, sent a letter to the FDA urging the agency to take action against JUUL, which has a boxy-sleek design that resembles a flash drive.
But not all committee members took issue with how the FDA has handled e-cigarettes so far. Rep. Sanford Bishop (D-Ga.) thanked Gottlieb for delaying certain regulations for e-cigarettes until 2022, noting that many of his constituents are switching to e-cigarettes to help them stop smoking.
However, Bishop did convey his concerns about children’s access to e-cigarettes.
Cannabis for Pain Control
Members also discussed marijuana as an alternative treatment for pain control, and whether or not its $5.8 billion budget request was sufficient.
Rep. David Young (R-Iowa) suggested that moving marijuana to a different schedule might make it easier to study. Marijuana (cannabis) is currently classified as a schedule I drug by the Drug Enforcement Agency, meaning that its “defined as drugs with no currently accepted medical use and a high potential for abuse.” However, many states have legalized cannabis for medicinal and/or recreational use.
Gottlieb said that it is already possible to study schedule I drugs, and that a supply of botanical marijuana, and its derivatives, is currently available for research through the National Institute on Drug Abuse (NIDA) supply program.
Asked for his “general thoughts,” on marijuana use, Gottlieb said that the “best way to deliver an active pharmaceutical ingredient is in a measured dose, in a form where you can purify the ingredient and you know what you’re getting. Rolling something up in a piece of paper and lighting it on fire and smoking it is not the most efficient way to deliver an active pharmaceutical ingredient.”
“I can’t think of another drug that we deliver that way, at least therapeutically… because you want to make sure the patient is getting a reliable dose and a reliable effect with each administration,” he added. “Also, the lung itself isn’t a very efficient drug deliver platform. We generally would prefer not to deliver drugs through the lung unless we were treating the lung in some fashion.”
A Bold Request
Gottlieb highlighted agency initiatives that would be made possible if the $5.8 billion FY 2019 budget request is met. The request includes $473 million in budget authorities and $190 million for user fees, he noted.
Subcommittee Chair Robert Aderholt (R-Ala.) called the request the “boldest and largest funding request in recent memory” for the agency.
Gottlieb touted plans to build a new “knowledge management system” for storing the “collected experience” of medical product review teams, identifying “scientific precedence,” and “bring[ing] more consistency to decision-making.”
The FDA will also open a policy office inside the Office of New Drugs to “promote policy, transparency, and consistency,” he said. Information culled from the new system could then be used to create hundreds of disease-focused guidance documents, he added, which would make drug development more efficient.
A portion of the budget, about $58 million, would be used to fund the transition to more modern manufacturing methods, such as continuous manufacturing.
Such a system would allow flu vaccines to be developed more quickly in a cell-based environment, rather than in eggs — the current process — and in a period of weeks, not months.
“You could scale up much more quickly and you could convert to different kinds of vaccine, if you saw changes in the contours of the resistant patterns over the course of a season,” he said
In other budget issues, Lowey noted that FY2019 budget represents a $372 million increase over the FY 2018 budget, but cautioned that the food safety budget, which saw a $10 million increase, was “insufficient” and barely enough to keep up with inflation.
She also pointed to the absence of a “vision” for how the agency would address the opioid epidemic.
“Every level of government must do all it can to combat the opioid epidemic,” she said.