As I described before, FDA broke precedent by not releasing the full Technical Project Lead (TPL) reports summarizing its positive decisions on 8 electronic nicotine delivery system (ENDS) products made by Logic Technologies. Instead, it just released 4 of the 56 pages, most of which constituted uninformative boilerplate.
There is no excuse for withholding this information, especially because it is important for the scientific community and public to see if FDA remedied the deficiencies in its earlier authorization of several RJR Vuse Solo e-cigarettes.
To get these TPLs, on April 5, 2022, my colleague Lauren Lempert submitted a Freedom of Information Act request to FDA for the full TPLs. Given the timeliness of this process and the need for the public to understand the FDA’s decision-making process, she asked that the request be expedited.
Three days later FDA denied the request for expedited processing. Based on our past experience with FOIA requests to the FDA Center for Tobacco Products, it will likely be months or even years before the public gets access to this important document.
The FDA wrote:
I have determined that your request for expedited processing does not meet the criteria under the FOIA. You have not demonstrated a compelling need that involves an imminent threat to the life or physical safety of an individual. Neither have you demonstrated that there exists an urgency to inform the public concerning actual or alleged Federal Government activity. Therefore, I am denying your request for expedited processing. [emphasis added]
In other words, with major decisions still pending on Juul, menthol and other products, FDA has decided that there is “no urgency to inform the public concerning” its decision making process around ENDS and other new tobacco products.
Lauren has appealed, arguing:
The Technical Project Lead Decision Summary explains how and why FDA reached a determination that products that are the subject of the Marketing Granted Orders are appropriate for the protection of the public health. These decision summaries provide critical information for the public, scientists, and public health researchers about FDA’s decision-making process and are essential for ensuring that the public, scientists, and researchers have confidence that the FDA is indeed protecting the public health. By withholding the full TPL report, FDA is eroding that confidence and raising suspicions that it has something to hide.
It is urgent that FDA provide the requested report because the FDA is currently poised to issue decisions on whether to grant permissive marketing orders for the e-cigarette products that are the most popular with youth and that enjoy the greatest market share, and it is essential that the public understand how these decisions are made.
… there is an urgent need to obtain this information so that researchers can determine whether the authorized products are appropriate for the protection of the public health, to understand how FDA reached its determination, and to provide insight into how FDA is likely to make these determinations for future PMTAs …
She went on to describe how researchers specifically need this information to follow advice in designing future research proposals to the FDA:
Additionally, there is an urgent need to obtain this information well before the May 15, 2022, letter of intent and the July 14, 2022, application deadline for the Tobacco Centers of Regulatory Sciences (TCORS) renewal applications for TCORS funding pursuant to RFA-OD-22-004 to understand how our proposed research could best inform FDA’s regulatory decisions. The importance of this information to TCORS researchers was emphasized in one of the slides presented at FDA’s March 21, 2022, Pre-Application Webinar for Tobacco Centers of Regulatory Science (TCORS) by Dr. Dana van Bemmel, Chief of Research Operations and Advisory Resources Branch, Office of Science, Center for Tobacco Products. Dr. van Bemmel urged potential applicants to consider “MRTPA & PMTA submissions” to better understand what “regulatory decisions could potentially be made” based on applicants’ proposed research. However, although FDA makes Modified Risk Tobacco Product applications (MRTPAs) available to the public, it does not post or make available the PMTAs. Therefore, the only way researchers can try to understand FDA’s regulatory process and ways of evaluating PMTAs is to have access to FDA’s TPL decision summaries.
The FDA is making decisions that will affect millions of kids and adults, to say nothing of the fortunes of tobacco companies. The FDA keeps talking about its commitment to the best science and to openness. This behavior certainly does not reflect those values.