A Maryland federal judge on Friday said that he would grant a 120-day extension to the deadline for e-cigarette regulatory applications in light of the novel coronavirus outbreak that has strained U.S. Food and Drug Administration resources and disrupted supply chains.
Last week, the FDA asked the Fourth Circuit to extend the current May 12 deadline in light of the coronavirus outbreak, saying that many of the laboratories and research organizations conducting the clinical trials for the regulatory applications have shut down or otherwise halted in-person testing in light of the COVID-19 pandemic.
In a one-page indicative ruling, U.S. District Judge Paul W. Grimm said he would agree to extend the deadline for e-cigarette premarket tobacco applications to Sept. 9.
The FDA told the Fourth Circuit on March 31 that many of its staff have been enlisted by the U.S. Public Health Service to help fight the pandemic, limiting the agency’s ability to review applications.
“Also, virtually the entire FDA staff responsible for reviewing premarket applications will be teleworking until further notice,” the agency said in the letter. “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.”
Travel restrictions around the world have also limited the FDA’s ability to gather information about vape manufacturers in countries including Italy, China, Honduras, the Dominican Republic, Nicaragua and Mexico, according to the letter.
Emily Field – Law360 – April 6, 2020.