On August 22, 2023 our very own Dr. Willie McKinney, CEO, had the opportunity to express his views and opinions on the tobacco product review process to the FDA during their listening session. Below is a transcription of what he said.  If you would like to view the actual video, please visit our YouTube Channel.

“Today, I comment on the FDA’s 5-Year strategic plan.  I will comment mainly on strategic goals one and two since these goals have the greatest impact on the work that McKinney RSA undertakes for its clients. So, how might the CTP develop, advance, and communicate comprehensive and impactful tobacco regulations and guidance? FDA could support this strategic goal by having a task to modify its review approaches for the administrative phase of a PMTA. We’ve had the opportunity to review PMTAs prepared and submitted by others, so we understand that if applications are not structured in a certain way or are complete, the reviewer will have a very difficult time understanding the information. Frequently, we hear that filings are rejected for acceptance based on administrative issues such as the use of the wrong version of a form. 

It is unfortunate that products that have the potential for the greatest positive impact on overall public health are rejected at the first PMTA hurdle. This could be avoided by measuring the effectiveness of communications with industry stakeholders. Continual submissions of incorrect forms could signify ineffective communication. To rectify this, the FDA should consider introducing web portals that mandate the input of accurate information before generating a fully completed form. A similar web-based portal system used widely within the European Union for scientific data set submissions has proven efficient in streamlining the submission process and minimizing errors. So how might the CTP ensure timely, clear, and consistent product application review to protect public health? FDA could support this strategic goal by having a test to modify its PMTA categorization and prioritization approaches. Based on CTP September 2020 stated priorities, the PMTAs of some tobacco products, such as oral nicotine products, appear to be the last products to enter the review process. Additionally, small manufacturers of other tobacco products, such as e-cigarettes, have found their PMTA stuck in the review process even after robust efficiency responses. These manufacturers have no indication of when their applications will be processed or completed. CTP should consider a separate PMTA review lane for small manufacturers in order to address this uncertainty. Furthermore, it’s not clear if manufacturers of oral nicotine products and others that don’t have a youth use issue should submit data demonstrating an increased public health benefit of their non-tobacco flavored products. CTP should continue providing greater clarity on this issue in order to address this confusion. Lastly, the impact of delayed regulatory decisions and ambiguous communications can lead to unintended consequences. Harm reduction requires manufacturers to innovate and bring to market novel alternative tobacco products. For small manufacturers, innovation requires external investment. The prevailing regulatory uncertainty hampers the ability of small companies to secure funding. This can lead to fewer life-saving alternatives for adult smokers and the disappearance of small businesses that are critical to cigarette use reduction. Enhancing communication clarity with small businesses by CTP could help address uncertainties, thus facilitating the achievement of the agency’s strategic goals.  

Dr. Willie McKinney calls for efficient and transparent tobacco product review processes