FDA Develops Tobacco Product Performance Measures

Establishes time frames to review substantially equivalent, modified risk reports

Published in CSP Daily News

WASHINGTON -- The U.S. Food & Drug Administration (FDA) has announced the development of a set of performance measures that will help improve the timeliness and predictability of the review of certain types of tobacco products that it currently regulates.

The FDA has established four performance measures and timeframes:

  • For the review of regular Substantially Equivalent (SE) Reports.
  • For the review of Exemption from SE Requests.
  • For the review of Modified Risk Tobacco Product (MRTP) Applications.
  • For meeting requests.

It will implement all four measure beginning on Oct. 1, 2014, meaning that the FDA will start monitoring the time it takes to review and take action.

The time between now and implementation will be used to develop tracking systems for monitoring progress in meeting the performance goals. As the FDA gains more experience with reviewing provisional SE Reports, it intends to identify and implement measures for these submissions, as well.

The FDA will continue to strengthen and expand the review process, which will enable it to be well positioned to meet more ambitious performance standards, it said.

Mitch Zeller, director of the FDA's Center for Tobacco Products (CTP), has written the following feature entitled "The Establishment of Performance Measures & Timeframes for the Review of Certain Types of Tobacco Products":

"In the nearly five years since enactment of the Tobacco Control Act, FDA has worked to create a regulatory framework to oversee the manufacture, sale and distribution of tobacco products and has made great strides in implementing the Act. Today, FDA is announcing that we have developed a set of performance measures that will help improve the timeliness and predictability of the review of certain types of tobacco products currently regulated by FDA.

"FDA has identified the following set of measures and time frames for fiscal years 2015-2018 [ click here to view the chart].

"Over the past two years, CTP has made great progress in each of the three key steps within the SE review process: jurisdiction review, administrative review and scientific review. As of March 24, 2014, there is no longer a backlog of regular SE reports awaiting scientific review. CTP is starting scientific review on regular SE reports as they are received. As of April 4, 2014, the SE review process has concluded for 23.6% of the 981 regular SE Reports that were received before March 31, 2014. As of March 31, 2014, FDA has received 61 Exemption from SE Requests, to which 36 Refusal to Accept letters were issued as manufacturers did not meet the requirements for such exemption. FDA has also begun review of provisional SE Reports and issued the first decisions on these reports on February 21, 2014. Our work is ongoing with the remaining reports and requests, and the agency intends to reach decisions as expeditiously as possible.

"Of the seven MRTP Applications received as of Dec. 31, 2013, FDA refused to file/accept for a substantive review six of the seven applications because they failed to include information required under the TCA and/or were about products that CTP does not currently regulate; the seventh was withdrawn by the manufacturer. FDA is committed to helping industry better understand the tobacco product review process and its requirements in the law, and will continue holding public webinars and educational meetings.

"Conducting scientific reviews of product applications and meeting with external stakeholders are important aspects of our work. Going forward, FDA will continue to strengthen and expand these processes, which will enable us to be well positioned to meet more ambitious performance standards in the future."