GAO Report Highlights Shortcomings in FDA Review Process for New Tobacco Products

Today, U.S. Senator Richard Burr (R-NC) offered reaction to the release of a Government Accountability Office (GAO) report at the Senator's request to examine the Food and Drug Administration's (FDA) Center for Tobacco Products' (CTP) regulatory review process for new tobacco products. The GAO report concludes the CTP has failed to review new tobacco product submissions under the substantially equivalent (SE) pathway in a timely manner.

"This GAO report highlights that CTP has significantly underperformed in its mission to review new tobacco product submissions," said Senator Burr. "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. 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 Tobacco Control Act of 2009 gave FDA the authority to regulate tobacco products and authorizes the agency to assess and collect user fees from manufacturers for CTP's regulatory activities. The SE review pathway for the two types of submissions - provisional and regular - includes three key steps: jurisdictional review, completeness review and scientific review to determine if the tobacco product is substantially equivalent to a product on the market prior to February 2007.

The GAO report concluded that since 2009, FDA has collected over $1.1 billion in tobacco user fees - but as of today, has only made final decisions for 17tobacco products out of the 3,788 total SE submissions in the 3 years since FDA received the first SE submission in June 2010.

This GAO report identifies CTP's shortcomings and makes recommendations that the agency can take to operate more efficiently and effectively. Specifically, CTP should start by establishing performance measures, including setting time frames for final decisions on tobacco product submissions to ensure regulatory certainty and accountability.

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You can read the full report here.