Pandemic stifled processes for manufacturers, FDA,
WASHINGTON — The deadline for manufacturers to submit subsequent equivalence (SE) and premarket tobacco applications (PMTAs) has changed several times due to the U.S. Food and Drug Administration (FDA) actions and the courts in the form of lawsuits, according to court documents.
The May 12, 2020, deadline solidified after a judge in the U.S. District Court in the District of Maryland agreed with plaintiffs to set that date in stone. Then the coronavirus pandemic happened, eventually leading to a 120-day delay and a new deadline of Sept. 9, 2020.
This is how it happened: Over the course of several weeks beginning in early spring, the FDA received several letters from manufacturers asking for a delay, citing difficulties with third-party laboratories conducting tests, as well as stay-at-home orders forcing staff to work off-premise. The FDA expressed its own concerns about employees who had been redirected to COVID-19 issues and would be unable to focus on the new-product review process.
On March 30, the FDA filed a request with the District Court for a 120-day delay. The judge approved the delay, but a second court, the U.S. Circuit Court of Appeals in the Fourth Circuit, had to weigh in.
On April 21, the appeals court approved the delay; days later, the FDA amended its guidance on e-cigarettes, cigars and other products falling into this category to reflect the Sept. 9 deadline.
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