GAO Report Finds Lengthy Approval Process for New Tobacco Products

U.S. Senator Richard Burr says the Center for Tobacco Products has “significantly underperformed its mission” in regard to the regulatory review process for such products.

October 25, 2013

WASHINGTON, D.C. – The amount of time the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) takes to perform the initial review of new tobacco products is 18 months, according to a new General Accounting Office (GAO) report. The GAO sent the report to U.S. Sen. Richard Burr (R-NC), the ranking member of the Senate Committee on Health, Education, Labor and Pensions.

The report showed that the CTP has finished initial review steps for most new tobacco product submissions, but has yet to issue final decision for the majority of those submissions. “Several factors contributed to the significant amount of time it took for review of new tobacco product submissions, according to officials from CTP and tobacco manufacturers. CTP officials reported taking steps to address factors that contributed to the length of time the center has taken to review submissions, but the center has not established review time frames by which to assess progress,” the GAO found.

The GAO concluded that “four years after the Tobacco Control Act established CTP and about three years after the first new tobacco product submission, FDA has received about 4,000 submissions and collected over $1.1 billion in tobacco user fee funds. Although CTP has finished initial review steps for most of these submissions, as of June 2013, the center made a final decision on only six submissions and the time taken on reviews has been significant.

“Yet, as CTP moves forward with its work, the lack of performance measures like time frames for reviews of SE submissions will limit CTP’s ability to evaluate policies, procedures, and staffing resources in relation to CTP’s submission review process and, in turn, limit CTP’s ability to reasonably assure efficient operations and effective results.”

Burr responded that the CTP’s 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.”

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