On Monday 30th March the Department of Justice filed a federal request to the US District Court of Maryland for an extension of the Pre-Market Tobacco Application (PMTA) deadline. Originally set as 12th May, the deadline is now believed to be unfeasible. This is due to the unprecedented COVID-19 global pandemic. The request for a 120-day extension would take the new proposed deadline to Wednesday 9th September 2020.
What are the FDA’s concerns?
Several issues had been cited in the request for extension including:
- Laboratories and CRO’s responsible for the scientific studies have closed or suspended in-person work indefinitely
- Travel restrictions have hampered travel between offices and factories.
- Employees from the Center for Tobacco Products (CTP) have been deployed to the US Public Health Service to assist with Coronavirus-related work
What is likely to happen?
According to the motion…
“Defendants consulted with Plaintiffs, who indicated that they do not intend to oppose the motion but wish to express their misgivings about the extension on the record and therefore request leave to file a response”.
If this is the case then it is likely that the extension may be granted. Given the unprecedented situation, this would seem to be a logical step.
There are of course some implications to the proposed extension. The FDA have already stated that they intend to revise their enforcement policy which they announced in January 2020. The one year grace period that would follow a submission will also be effective from the new date. This means that a company who submit an application by 9th September 2020 would then be able to trade until 9th September 2021 whilst their application is under review.
If you were looking to start a PMTA submission late in the day then this deadline extension could be a saving grace. The additional time also means that we are able to on-board some additional PMTA projects here at Hall.
Hall Analytical have vast experience in PMTA projects and are at hand to help you navigate the process. Get in touch today to see how we can help with your submission