Keller and Heckman Symposium Panel January 2024

It’s back. I know he does, but I don’t, right? A lot of people ask me questions because of our lawsuit and stuff like that. We are one of the only approved products in states like Louisiana until that was just overturned by the judge. In different states that have these PMTA registry laws, I hate it. I think it’s unfair. If it’s only my company or any other company that stays on that list, the industry won’t survive. It’s literally impossible for the industry to survive. I believe we need as many tobacco product authorizations as possible to continue what we’ve been doing. I’ve been in this industry for 12 years now, and with only 23 “approved” products, the industry will never survive.

Question: When you talk about PMTA approvals, and I’m new to this space, it sounds like it’s a full product, right? It’s very much based on flavorings and appealing to children. Is there a way to break it into parts or components where they are pre-approved, and then it’s only a flavor or something else that’s the question mark? Or does everything have to be a full product that goes under review?

Response: I’m not a scientist or a lawyer, but no, the answer is no. They ultimately make decisions on the entire product, especially with the PMTA. There were comments submitted during the rule-making years ago proposing that FDA could use a monograph approach, like they do in other centers, to allow for a list of approved ingredients and different components. However, they did not go down that path. Their position is that the TCA creates a product-by-product approval pathway.

They have teased at certain events the potential for a somewhat abbreviated PMTA process when looking at the evolution of your product. They’ve mentioned noting and bridging techniques to abbreviate that process. However, this requires a fundamental paradigm shift in how you look at your R&D and product development. It essentially means that you have thought out the entire life cycle of your product to a certain extent about points where you’re going to change it. The best example of this is what PMI is doing for iQOS. Many of the authorizations that have happened, especially for that device, are for iterations of the device that are likely never to see the light of day. They’re just building upon that to try to get as close to the global standard of iQOS within the current framework.

As Dr. McKen said, they look at the entirety of the product. Even the abbreviation process is far beyond a monograph approach or something you’d see in other centers.

Initial Reactions:

First Speaker: If you were listening, the bar has moved again. The bar is essentially drugs. That’s the bar. No one has provided the science. I take it personally. Every consultant here who has prepared a PMTA, every ex-FDA person who helped us should take it personally. They’re not providing us tools, just guidance and regulation. One tool they could provide is a PMTA template for consistent applications that can be reviewed quickly. They don’t see they’re doing anything wrong. The courts support what we are doing, but did they read the decisions? When I read information that goes to the clients, it’s exactly opposite of what Dr. King has been saying. I’m a little disappointed and sad. I’ll pass the mic now.

Second Speaker: I’ll start on a more positive note. I believe everyone at the FDA, including Dr. King, holds the belief that switching to a lower-risk product is a good thing. Fundamentally, the difference in approach is how we view risk, industry versus agency. Dr. McKen’s point on cessation stood out, highlighted with my colorful pens. The youth issue is a continuing stumbling block, both in terms of flavor issues and products going through the process. Dr. King mentioned the strides made in reducing e-cigarette uptake among kids, but noted the most commonly used product among kids for the past 10 years has been e-cigarettes.

The takeaway from the public health standards comparison to safe and effective versus Dr. King’s lunchtime speech is that the risk defined here is youth uptake. That was another standout in Dr. King’s discussion.

Innovation Discussion:

Second Speaker (continued): What was missing in the discussion was a comprehensive look at innovation. The Tobacco Control Act has two prongs for the center to look at. Feedback from both the largest multinationals and the smallest members of my association indicate a lack of discussion on innovation. This is striking compared to the rest of the world, where innovation is a key part. From dealing with environmental impacts of vapor products to creating products attractive to adult consumers marketed responsibly, innovation is vital. The FDA’s lack of discussion on this is noteworthy.

Third Speaker: Dr. King noted the 21st Century Cures Act during his discussion on the Five-Year Plan for operational excellence. This act increased pay everywhere at FDA except for the Center for Tobacco Products, particularly the Office of Science, creating massive churn within the office. Advocacy and lobbying are crucial. My organization can’t lobby, but the churn within critical functions due to pay imbalances is significant. Professionals can switch to a different center for 20-30% more pay, which hampers operational excellence.

Fourth Speaker: Thank you for calling me a pro. Not many do that. This is to give you some visual representation of what we’ve been discussing. Can you hear me okay? We’ve heard some new things today, but this is our general reaction to CTP’s overall approach. It’s not a play by play, but half a million Americans die every year from cigarettes.

Visual Representation and Final Remarks:

Fourth Speaker (continued): We’re talking about serious issues, and these visuals highlight our overall reaction to CTP’s stance. This represents our frustration with the current regulatory environment and the need for better tools and consistent guidance to navigate these challenges effectively.