TMA and Vapor Voice recently held their “Finding Direction: Navigating PMTAs” seminar and virtual workshop, which was hosted by Troutman Sanders at its Richmond, Virginia office on August 22, 2019. The seminar was moderated by Jim Solyst, the Vice President of Federal Government Affairs at Swedish Match North America. Speakers included Troutman Sanders Partner Bryan Haynes, Kevin Burd, CEO North America Nicotine, Josh Church, Chief Regulatory & Compliance officer at JWEI Group, Mike Ogden, Sr. Vice President of Scientific & Regulatory Affairs at Reynolds American Inc., Dr. Samina Qureshi, Vice President at PSI International Inc., Dr. Lorraine Rusch, President at High Point Clinical Trials, and Steve Sibley, Vice President at Synchrogenix. The seminar was provided to give companies insight on navigating the FDA’s Guidance regarding Premarket Tobacco Product Applications (PMTAs) for Electronic Nicotine Delivery Systems (ENDS), published in June 2019, which dictates the standards for PMTA submission process as companies prepare their submissions for the May 2020 deadline.
A Vapor Voice article entitled “Strongly Recommended” written by Timothy Donahue, summarized the key points of the seminar. According to Donahue, the consensus from all eight panel speakers is that “there is still a level of uncertainty in the industry on whether any products will be approved” and that the “process will seem overwhelming, but not impossible.” Due to the amount of ambiguity surrounding the PMTA process and the vagueness of the FDA Guidance dictating the requirements for submission, the seminar speakers made sure to highlight what companies should focus as they prepare their submissions.
In his article, Donahue quotes a speaker who emphasizes the fact that “‘ultimately, what the FDA wants you to do is to demonstrate that you know your ENDS products,’” and that the “‘goal is to be able to show that you know and understand what you are selling/producing and that you will always be able to provide further information about your product.’” A large focus of the seminar and Donahue’s article is the drastic deadline shift—which was moved from August 2022 to May 2020—and how companies should approach the daunting PMTA process under such significant time restraints. The article states that panel speakers agreed that “companies should have a dedicated team or individual in charge of the PMTA process” in order to successfully meet the requirements of the FDA by the submission deadline. According to Donahue, a speaker explained that there “‘will be very few companies that will have a ready-to-go-as-intended submission by May,’” and that the FDA’s requirements for submission and the deadline “‘are at odds with each other.’”
In a section entitled “Considering the Content,” Donahue summarizes the panel’s advice to manufacturers regarding the scope and quality of scientific data that is required for the premarket review process. He notes that the panel “agreed that studies must be conducted in valid manner that is generally accepted by the scientific community” and that the “scientific evidence must be based on a unified standard—a methodology that everyone can adopt.” Donahue notes that to do this, the panelists recommended that companies “consult the FDA for advice” regarding the FDA’s expectations or for clarity on the Guidance’s many gray areas.