U.S. Senators Demand FDA Reform its PMTA Process

U.S. Senators Joe Manchin, Rand Paul and Ted Budd (R-NC) penned a letter urging the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) to reform its premarket tobacco product application (PMTA) process.

The Senators also requested information regarding CTP’s policies and actions that would ensure they are acting in an efficient way that is based on science and evidence.

“Cigarette smoking is the leading cause of preventable disease and death in the United States, where nearly 31 million Americans smoke cigarettes,” the group wrote in part. “For the FDA to meet its harm reduction goals, it must have a functioning authorization process.

“Since 2009, more than 26 million [PMTAs] have been submitted for new tobacco products in the U.S. Of those 26 million applications, the CTP has authorized fewer than 50… The availability of scientifically substantiated, authorized-PMTAs or MRTPs could potentially improve health outcomes for smokers currently using riskier products.”

For the FDA to meet its harm reduction goals, it must have a functioning authorization process, the Senators state, adding that the agency’s authorization rate is not in keeping with CTP policy acknowledging that tobacco products fall on a continuum of risk.

“The CTP has previously attributed its backlog to staffing shortages, but CTP’s staff has more than doubled over the past decade, from 426 employees in 2013 to more than 1,100 today,” the Senators state. “Since 2009, the FDA has also had the authority to assess and collect user fees from tobacco manufacturers and importers, with those fees being $712 million annually since 2019.

“Given these significant resources, there is no reason why the CTP should be so drastically out of step with the [Food, Drug and Cosmetic] Act’s requirements.”