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Brian King: Lead agency under surveillance
There are many caveats about how the US Food and Drug Administration’s Center for Tobacco Products (CTP) has performed its duties. Speaking briefly at GTNF 2022 in Washington, D.C., new CTP director Brian King did little to quell those concerns. However, he acknowledged the continuity of risk. “We have some products that are less dangerous than combustible tobacco, and that’s an important component of that dialogue,” King said.
King told attendees that the CTP has the potential to assess the risk of youth starting to smoke and equate it with the ability of adults who use e-cigarettes to quit combustible cigarettes.
“In my opinion [the] The standard of public health is essential to the work we do, and it is a guiding light in my decisions and decision-making,” he said. “At the end of the day, it comes down to science … it’s very important to me that we use this as our guiding light.” And, of course, applicants have a duty to provide the most reliable indications to inform decision-making.”
The FDA has long been criticized for its handling of the premarket approval (PMTA) process for tobacco products, and is currently defending several lawsuits by vapor companies challenging marketing denial orders (MDOs), including two recently filed by Juul Labs. refusal of the regulatory body to publish documents confirming the MDO.
Juul claims the agency has ignored more than 6,000 pages of user-submitted data on inhalant aerosols, according to Juul Labs Chief Regulatory Officer Joe Murillo, who spoke at the conference.
King said a significant number of young people still use flavored and disposable products. However, he also said the potential benefits for adult smokers “were mutually exclusive” of concerns about youth uptake. “I don’t think they should necessarily be separate; they can definitely be studied at the same time,” he said. “But we have to make sure we look at both sides of the science when we make decisions.”
King said the agency “continues to make progress” on about 1 million PMTAs for nicotine products other than cigarettes. According to him, more than 90 percent of requests have been fulfilled. “We have 350 admissions so far, and about 800,000 people have received RTA. [a refuse-to-accept letter]And I’m hoping that within the next few weeks we’ll be able to pass 100 percent of that 1 million.”
Being accepted for review is only the first step in the PMTA process. There are six stages or rounds in the PMTA process. An application is submitted after acceptance, followed by a serious review before action is taken. King called the first step important. “[It’s] is an important step and I’m committed to making sure things move as quickly as we can,” King said.
King recently told the AP that he believes “there is a lot of important science and innovation” that has taken place in the vaping industry in recent years, and the most important is nicotine salts in e-liquids. “We know that smoking is a very effective way to get nicotine across the blood-brain barrier. So it was very difficult to compete with that efficiency in another product,” King said in an interview. “But in the case of nicotine salts, you have the ability to deliver nicotine more efficiently, which could hold public health promise in terms of giving smokers enough nicotine. [off cigarettes] completely”.
King also discussed the FDA’s ability to force companies to comply with its MDO requirements. So far, very few companies have demanded that their products be withdrawn from the market. King said the agency has plenty of enforcement options to bring both manufacturers and retailers to heel.
“We have several tools, including advisory efforts,” he said. “We also have regulatory enforcement actions, including voluntary recalls, as well as other requested recalls. We may also take administrative action, including civil monetary penalties (from the manufacturer’s point of view, this penalty cannot exceed $15,000 for any one violation or $1 million for any number of violations related to a single activity),” King explained. “As for legal action, we can do injunctions, injunctions, as well as prosecutions. I will say, nothing is off the table when it comes to execution and execution.”
King also updated attendees on the FDA’s external review of CTP procedures being conducted by the Reagan-Udall Foundation. Lauren Silvis, former FDA chief of staff, “has been appointed to chair a panel asked to evaluate tobacco-related regulatory processes and agency operations to help the agency meet new challenges to reduce tobacco-related deaths and disease.” achieving the public health mission.
“Within weeks of accepting this role, we were told there would be an external evaluation,” King said. “Actually, I totally welcome it. I think this is a good opportunity, especially with the new leadership, to identify areas where we are doing very well, but also to identify areas where we can improve efficiency and effectiveness. I had meetings [Silvis] and his team, and I’m sure we’ll get some very useful information.
“It’s an ambitious timeline, 60 working days, so it will take about 90 days. It should be completed by the end of the year, mid-December, and I look forward to hearing the proposals. And I’m very open minded about it. I’m always ready to improve.”
King also expects there will be opportunities for outside engagement, including listening sessions. He was unable to provide specifics in his speech, but said he would welcome input from others in terms of informing CTP processes.
“It’s not one-size-fits-all, but I think we have great opportunities here,” he said. “I’m totally open to listening to the assessor and using it in a very helpful way… and then we’ll take it from there… As I’m sure many of you have heard in public, my calendar is filling up fast. , and we’re meeting a lot of people — I know I’ve met a few of you in the room, and I appreciate the opportunity to meet people from across the spectrum, whether it’s industry or healthcare … hearing people’s insights, what your priorities are.
“They were very fruitful and useful for me. I’m listening. I think this is a very useful opportunity for me in terms of hearing what suggestions there are from industry and what areas you think the FDA would benefit from doing to make your life easier in terms of submissions and applications and applications. [what] the processes are too complex and could be improved,” King said. “I am fully committed to making sure that happens.”