New Tobacco Products: FDA Needs to Set Time Frames for Its Review Process

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A letter report issued by the Government Accountability Office with an abstract that begins "As of January 7, 2013, the Food and Drug Administration's (FDA) Center for Tobacco Products (CTP) had finished initial, but not final, review steps for most of about 3,800 submissions for new tobacco products (those not on the market on February 15, 2007). Ninety-nine percent of the submissions received by FDA were made under the substantial equivalence (SE) pathway. CTP determines whether the new tobacco product in an SE submission has the same characteristics as a predicate tobacco product (a product commercially marketed in the United ... continued below

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United States. Government Accountability Office. September 6, 2013.

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Description

A letter report issued by the Government Accountability Office with an abstract that begins "As of January 7, 2013, the Food and Drug Administration's (FDA) Center for Tobacco Products (CTP) had finished initial, but not final, review steps for most of about 3,800 submissions for new tobacco products (those not on the market on February 15, 2007). Ninety-nine percent of the submissions received by FDA were made under the substantial equivalence (SE) pathway. CTP determines whether the new tobacco product in an SE submission has the same characteristics as a predicate tobacco product (a product commercially marketed in the United States on February 15, 2007, or previously found by FDA to be substantially equivalent) or has different characteristics that do not raise different questions of public health. Initial review steps include CTP's determination of whether the new product is a type regulated by FDA and whether the submission is missing information. For most SE submissions, CTP took more than a year and a half from the date a submission was received to the date these initial steps were completed. Of the 3,788 SE submissions, 3,165 were received by FDA prior to a statutory deadline (March 22, 2011) allowing the product to be marketed unless CTP finds that they are not substantially equivalent. SE submissions received after that date cannot be marketed until CTP determines they are substantially equivalent. In late June 2013, CTP made a final decision on 6 of the 3,788 SE submissions, finding that 2 of the products were substantially equivalent and that 4 were not; the remaining submissions were still undergoing CTP review. CTP officials and manufacturers told GAO that 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 CTP to review SE submissions. While CTP is working to address these factors by, for example, disseminating information to manufacturers to improve submission quality and developing training for staff, CTP does not have performance measures that include time frames for making final decisions on submissions by which to assess its progress. Without time frames, CTP is limited in its ability to evaluate policies, procedures, and staffing resources in relation to its review process and, in turn, is limited in its ability to reasonably assure efficiency and effectiveness."

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Government Accountability Office Reports

The U.S. Government Accountability Office (GAO) is an independent, nonpartisan agency that works for the U.S. Congress investigating how the federal government spends taxpayers' money. Its goal is to increase accountability and improve the performance of the federal government. The Government Accountability Office Reports Collection consists of over 13,000 documents on a variety of topics ranging from fiscal issues to international affairs.

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  • September 6, 2013

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  • June 12, 2014, 7:50 p.m.

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United States. Government Accountability Office. New Tobacco Products: FDA Needs to Set Time Frames for Its Review Process, report, September 6, 2013; Washington D.C.. (digital.library.unt.edu/ark:/67531/metadc301212/: accessed April 23, 2018), University of North Texas Libraries, Digital Library, digital.library.unt.edu; crediting UNT Libraries Government Documents Department.