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FDA asks courts for PMTA deadline extension due to coronavirus outbreak

 

On Monday, March 30, the U.S. Food and Drug Administration (FDA) issued a letter to the Maryland District Court requesting a 120-day extension to the impending deadline for the PreMarket Tobacco Applications (PMTA) process.  Per the FDA deeming regulations of 2016, these applications are required of all manufacturers for each vapor product to be offered to the public market.  Without an application already in the system by May 12 for federal review, the related product would need to be pulled immediately from store shelves.

The reason given by FDA’s Mitch Zeller, Director of the agency’s Center for Tobacco Products (CTP), focuses on the many regional lockdowns occurring across the country due to the escalating coronavirus outbreak.  In the letter to the courts, FDA lawyers explain that due to a wide variety of state and local governments asking their citizenry to self-quarantine for several weeks or - in the case of the Commonwealth of Virginia – until at least June 10, many of the laboratories and organizations involved in the PMTA process will be suspending operations for the foreseeable future.  The civilian scientists employed by these laboratories are essential because they perform the necessary clinic studies that FDA officials will use to determine the approval or denial of each PMTA application.

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Furthermore, the FDA letter continues, the agency itself is experiencing staffing issues of its own amid this national crisis.  Zeller’s CPT is currently reassigning many of its employees to various other federal agencies to help manage and coordinate the U.S. government’s pandemic response.  Other staff members are being asked to work remotely in an effort to adhere to the social distancing guidelines provided by the White House in coordination with the U.S. Centers for Disease Control and Prevention (CDC). 

Moreover, as a result of the outbreak, some employees from the FDA’s Center for Tobacco Products (CTP) have been deployed to work for the U.S. Public Health Service, including many within one of the divisions of CTP’s Office of Science, which is responsible for reviewing premarket applications…Also, virtually the entire FDA staff responsible for reviewing premarket applications will be teleworking until further notice…While the FDA has taken steps to enable work to be performed remotely as much as possible, the agency anticipates that it will take additional time for a remote workforce to receive and process applications and conduct scientific review of those applications.”

This is not the first time that the FDA has extended the PMTA deadline.  In fact, this latest effort is not yet official until the Maryland District Court says so.  The current May 20 deadline was originally mandated by District Court Judge Paul W. Grimm in July 2019 after the American Academy of Pediatrics and other plaintiffs sued the FDA over the agency’s alleged refusal to set a definitive date.  On one occasion, the FDA pushed the PMTA deadline forward a full five years.  Per yesterday’s FDA letter to Judge Grimm, the American Academy of Pediatrics supports the FDA’s request for this latest 120-day extension.

Related Article:  Judge makes it official: Vape retailers have 10-months to submit PMTAs…or else

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