Sen. Richard Burr (R-N.C.) said that the recent release of a Government Accountability Office report examining the FDA’s Center for Tobacco Products’ regulatory review process for new tobacco products showed that the CTP “significantly underperformed in its mission.”
“It is clear that meaningful improvements need to be made to address FDA’s shortcomings to ensure a predictable regulatory review pathway and greater accountability for meeting performance goals in a timely manner,” Burr said. “The FDA should begin by immediately implementing the GAO’s recommendations to set time frames for making final decisions on tobacco product submissions and establish performance metrics to monitor the agency’s ability to meet performance goals and time frames.”
The FDA was given authority by the Tobacco Control Act of 2009 to regulate tobacco products and assess and collect user fees from manufacturers for CTP’s regulatory activities.
According to the GAO report, the FDA, since 2009, has collected more than $1.1 billion in tobacco users fees while only making final decision for 17 tobacco products out of a total of 3,788 SE submissions in three years.
The GAO’s report identified CTP’s shortcomings while making recommendations for more efficient and effective operation. The report specifically said that CTP should establish performance measures, including setting time frames for final decisions on tobacco product submissions to ensure regulatory certainty and accountability.