The US Food and Drug Administration (FDA) has submitted a letter to the U.S. District Court for the District of Maryland asking Judge Grimm to extend the May 12, 2020 court-ordered PMTA deadline by 120-days to September 9, 2020 “in light of the global outbreak of respiratory illness caused by a new coronavirus.”
The FDA explained in its submission that “the global coronavirus outbreak poses unforeseen challenges and has made the May 12 deadline a public health risk to those who cannot comply with the deadline through telework.” In addition, FDA explained that telework also will complicate and delay FDA’s review of applications, according to a release by the Vapor Technology Association (VTA).
In deciding to request a 120-day extension, the FDA noted that it had received requests from numerous trade associations and companies, including consultants involved in the PMTA process, for extensions “between 8 weeks and 180 days, with the majority of requests for 180 days.” The VTA was one of those entities that submitted a request to FDA and did so on March 20, 2020 outlining the basis and necessity for deadline extensions for large manufacturers and small manufacturers.
At this point in time, no one can predict the length and severity of the COVID-19 commercial shutdown. The FDA explicitly recognized this point in the Second Declaration of Director the FDA’s Center for Tobacco Products (CTP) Mitch Zeller which accompanied the letter to the Court.
In his Declaration, Zeller stated that “it is not clear at this point what the precise impact of the COVID-19 outbreak will be on the scope of FDA’s ability to complete application reviews within the 12-month period of time once applications are filed.”
That is precisely why VTA requested a new deadline of November 2020 (or at least 180 days from business resumption) for large manufacturers, and a new deadline of February 2021 (or at least 270 days from business resumption) for small manufacturers, according to the VTA statement. “To that end, VTA explained that ‘the question of whether these deadline changes are sufficient or ultimately realistic can and must be re-evaluated in the coming months as more information comes to light about the length and severity of the commercial shutdown due to COVID-19.’”
In its letter to the District Court, FDA notes that the plaintiffs (American Academy of Pediatrics, et al.) will not oppose the FDA’s request, though the plaintiffs have requested the opportunity to “express their misgivings about the extension on the record.” In order to rule, Judge Grimm still will have to have the case remanded to him by the Fourth Circuit and then he would need to make his decision on whether or not to grant the FDA’s request.
However, given the strong case made by the FDA, the obvious insurmountable obstacles created by the coronavirus, and the apparent lack of opposition by the plaintiffs, a ruling extending the deadline is reasonably likely though still not certain.