Tobacco Reporter‘s July 2016 edition:
Navigating the PMTA
Now that the industry has had an opportunity to digest the U.S. Food and Drug Administration’s (FDA) “deeming” regulations announcement, it is time to get to work.
The first lawsuits challenging the agency’s rule have been filed, and many have pinned their hopes on proposed legislation that would take the sting out of the new regulations, most notably by bringing forward the unreasonable 2007 predicate date for “new” products.
The outcome of those initiatives, however, is far from certain and will take time to become apparent. In the meantime, the clock for compliance has started ticking.
According to the current rules, the industry will have to obtain FDA approval for all products that weren’t on the market as of Feb. 15, 2007. That grandfather date will force the majority of e-cigarette and electronic nicotine-delivery system manufacturers into the FDA’s premarket tobacco product application (PMTA) pathway—the costliest and most complex avenue from a regulatory perspective.
Wells Fargo Securities estimates that a PMTA would require an average of 1,500 hours to complete, while commentators have put the cost per application at anywhere between several hundred thousand dollars and a whopping $10 million.
Depending on the size of their company, applicants have between 24 and 30 months to submit their PMTAs—the blink of an eye, really, given the amount of paperwork involved. To demonstrate that their products are “appropriate for the protection of public health,” manufacturers will have to submit boatloads of data, including information on components, ingredients and production processes, along with detailed explanations of how the figures were obtained.
Meeting the FDA’s exacting requirements will require focus and strict discipline. The trick is to start early, stay on task and communicate with the FDA as frequently as the agency will allow.
To help companies navigate the market authorization process, Jason Rock of GlobalSubmit has shared some best practices with Tobacco Reporter. Drawing on his experience as the project lead for the first-ever approved PMTA, Rock describes the do’s and don’ts of a successful application.
While following these guidelines will, by itself, not guarantee success, doing so should save time and enable applicants to avoid common pitfalls. As much as we’d like to, Tobacco Reporter cannot send the FDA back to the drawing board. But we can help you be as prepared as possible—and, hopefully, make the PMTA ordeal just a tad less painful.
Read the July 2016 digital edition here
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