New Report Highlights Shortcomings in FDA Review Process

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New Report Highlights Shortcomings in FDA Review Process


WASHINGTON, D.C. -- Tobacco industry insiders are not the only ones who have questioned the pace at which the Food and Drug Administration's (FDA) Center for Tobacco Products is approving new products via the substantial equivalence (SE) pathway. A recent report by the Government Accountability Office (GAO) concluded that the CTP has failed to review new submissions through the SE pathway in a timely manner.

The report came at the request of U.S. Sen. Richard Burr (R-N.C.).

"This GAO report highlights that CTP has significantly underperformed in its mission to review new tobacco product submissions," Burr said. "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.”

According to Burr, the GAO report concluded that since 2009, the FDA has collected more than $1.1 billion in tobacco user fees. However, as of now, the agency has only made final decisions on 17 tobacco products out of the 3,788 total SE submissions in the three years since the FDA received the first SE submission in June 2010.

“The FDA should begin by immediately implementing the GAO's recommendations to set timeframes for making final decisions on tobacco product submissions and establish performance metrics to monitor the agency’s ability to meet performance goals and timeframes," said Burr.

The GAO report noted that CTP officials and manufacturers have said several factors (such as CTP requests for additional information from manufacturers for submissions, and having to hire and train new staff) impacted the time it took to review SE submissions.

As a result of its review, the GAO recommended the FDA establish performance measures that include timeframes for making decisions on new tobacco product submissions, and that the agency monitor performance relative to those timeframes. The Department for Health and Human Services agreed with the recommendations, according to the GAO.

The Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA the authority to regulate tobacco products, and authorizes the agency to assess and collect user fees from manufacturers for the 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.