House Subcommittee Looks at Center for Tobacco Products

Bill calls for closer oversight of new-tobacco-product approvals process

Published in CSP Daily News

Brett Guthrie

WASHINGTON -- U.S. Representative Brett Guthrie (R-Ky.) has introduced H.R. 389, the Transparency in Tobacco User Fees Act, and the House Energy & Commerce Subcommittee on Health this week reviewed the bill and other legislation in two days of hearings. The legislation would require closer oversight of the spending and new-tobacco-product evaluation process of the U.S. Food & Drug Administration's (FDA) Center for Tobacco Products (CTP).

Dr. Marcia Crosse, director of health care at the Government Accountability Office (GAO), testified, "In 2009, the Tobacco Control Act granted FDA authority to regulate tobacco products such as cigarettes. The act authorizes FDA to assess and collect user fees from each tobacco manufacturer and importer for FDA activities related to tobacco product regulation. … The Food & Drug Administration (FDA) spent (obligated) less than half of the $1.1 billion in tobacco user fees it collected from manufacturers and others from fiscal year 2009 through the end of fiscal year 2012; however, FDA's spending increased substantially in fiscal year 2013. Through Dec. 31, 2013, FDA spent nearly 81% of the approximately $1.75 billion in fees collected by that time."

Guthrie said H.R. 389 would monitor spending by the CTP, authorized in 2009 under the Family Smoking Prevention& Tobacco Control Act and "would exercise oversight over the [CTP] and require they submit a report to Congress on their activity."

The CTP oversees implementation of the Tobacco Control Act. Some of its responsibilities include setting performance standards, reviewing premarket applications for new and modified-risk tobacco products, requiring new warning labels and establishing and enforcing advertising and promotion restrictions.

A GAO report, Tobacco Products: FDA Spending & New Product Review Time Frames, released April 8, 2014, said, "The lack of performance measures like time frames for reviews of SE [substantially equivalent new-product] 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."

It continued, "We recommended that FDA establish performance measures that include time frames for making decisions on new tobacco product submissions and that the agency monitor performance relative to those time frames. [The U.S. Department of Health & Humans Services (HHS)] agreed with our recommendation, and as of April 2, 2014, FDA officials said that they expect to identify performance measures that include time frames for the regular SE and exemption from SE review processes in spring 2014, and to implement these performance measures by Oct. 2014."

The GAO report also said, "Although FDA has increased its staff and training for staff, tobacco industry stakeholders expressed concerns about whether CTP will have a sufficient number of qualified staff to review the backlog of the more than 4,000 new tobacco product submissions received as of Dec. 31, 2013, and also review new submissions that may be made in the future, particularly if FDA asserts jurisdiction over new types of tobacco products that are not currently subject to FDA's regulatory authority."

Guthrie said that his bill "is a good-government, commonsense approach to ensure that this agency of government works and is accountable to Congress and the committee that is vested with its authority. Tobacco user fees are not subject to reauthorization so there is little opportunity for the industry to enter into discussions with FDA the way pharmaceutical companies or device manufacturers can. As the oversight body, I believe we should be able to see how these funds are being used, the number of applications being reviewed or still pending, and get a clear picture of the division's work."

Crosse told Guthrie, "I think it's appropriate for Congress to have information on the operations of the [CTP]."

Click here to view the full text of H.R. 389. And click here to view the full text of the GAO report.

Keywords: 
cigarettes, OTP