By David B. Clissold –
The United States Government Accountability Office (“GAO”) recently released a report examining FDA’s Center for Tobacco Products (“CTP”) entitled, “New Tobacco Products: FDA Needs to Set Time Frames for Its Review Process” (“GAO Report”). The report focused on CTP’s review of new tobacco product submissions, responses to meeting requests, and use of resources. Under the Family Smoking Prevention and Tobacco Control Act (“Tobacco Control Act”), a manufacturer may make a submission to CTP to determine whether the manufacturer may introduce a “new tobacco product” to the market in the United States. One type of submission is known as a Substantial Equivalence (“SE”) determination (for more on the SE pathway, see our previous posts here and here).
A manufacturer may make a SE submission if either (1) a new tobacco product has the same characteristics as a predicate tobacco product (a product marketed in the United States on February 15, 2007), or a product previously found by CTP to be substantially equivalent; or (2) the new tobacco product has different characteristics from a predicate tobacco product, but does not raise different questions of public health. According to the GAO Report, CTP reviews SE submissions in three steps: (1) jurisdiction review to determine if the product is regulated by FDA; (2) completeness review to determine if the submission is missing information; and (3) scientific review to determine if the product is substantially equivalent or not.
SE submissions began rolling in to CTP in 2010, and over 3,000 were submitted in the second quarter of FY 2012. The report states:
As of January 7, 2013, the vast majority of new tobacco product submissions FDA received from manufacturers were made under the SE pathway. CTP has finished initial review steps (jurisdiction and completeness reviews) for most SE submissions, but CTP has not made final decisions for most submissions . . . 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.
According to the GAO Report, CTP officials cited “insufficient information from manufacturers in SE submissions” as the main cause of the delay. Industry countered that “guidance provided by CTP was neither timely nor adequate for manufacturers to provide what CTP would consider SE submissions with sufficient information.” In particular, manufacturers pointed to the “environmental assessment” as an example of the type of information that FDA did not indicate was required until after the majority of SE submissions had been made. Industry makes a good point. A January 2011 guidance document, “Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products,” does not mention the need for an environmental assessment. However, in September 2011, CTP issued a frequently asked questions document stating that manufacturers must include an environmental assessment in their submissions (FDA, Draft Guidance for Industry and FDA Staff, Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions (Sept. 5, 2011)). This guidance simply refers the reader to 21 C.F.R. Part 25 for additional information and states: “If you have questions regarding what you should include in your environmental assessment, and would like to discuss your questions with the agency, please contact CTP to request a meeting . . . .”
The GAO Report noted several steps that CTP is taking to reduce the time for review of SE submissions, including the creation of a standardized form for manufacturers to use when submitting new tobacco product information for review, and increasing the number of CTP reviewers. However, the GAO Report noted:
While CTP is moving forward with its reviews of SE submissions and efforts to improve review times, CTP does not have time frames for reaching a final decision on submissions. Time frames would allow CTP to evaluate its efficiency and effectiveness and help it make appropriate adjustments. Under federal standards for internal control, control activities that establish performance measures, such as time frames, and the monitoring of actual performance against measures are an integral part of operating efficiently, achieving effective results, and planning appropriately. There are no time frames set by statute for the SE pathway, and CTP has not established performance measures that include time frames for making final decisions on the review of SE submissions. Although CTP officials agreed that establishing time frames would be useful for performance evaluation, CTP has not identified specific plans to establish such time frames. According to CTP officials, they have not yet established time frames because they first need to collect and analyze information about how long each review step should take. Yet without time frames, CTP is limited in its ability to evaluate policies, procedures, and staffing resources in relation to its review process and this, in turn, limits CTP’s ability to reasonably assure efficiency and effectiveness. As a result, CTP is limited in its ability to determine the adjustments needed to make improvements.
In its written comments to the GAO Report, The Department of Health and Human Services (“HHS”) stated that FDA will identify performance measures and time frames for SE reviews within six months, monitor performance, and modify the review process, if appropriate, in order to meet agency objectives.
These proposals by CTP are laudable goals. However, there remains a disconnect between industry’s ability to prepare “complete” SE submissions, and CTP’s ability to review them. This is not entirely unexpected, considering that neither industry nor CTP had any experience with creating or reviewing SE submissions. Nevertheless, it is at least an open question whether CTP really needs all of the information it currently requires. For example, in 1997, FDA exempted the vast majority of human drug and biologics, medical device, animal drug, food, and food additive submissions from the requirement of an environmental assessment. At that time, FDA noted that the action “increases the efficiency of the agency’s implementation of [the National Environmental Policy Act] by substantially reducing the number of [environmental assessments] required to be submitted by industry and reviewed by FDA and by providing for categorical exclusions for additional classes of actions that do not individually or cumulatively have a significant impact on the human environment.” National Environmental Policy Act; Implementation; Federal Regulatory Review, 62 Fed. Reg. 40,570 (July 29, 1997). In light of these existing categorical exclusions, it is not immediately obvious why an environmental assessment plays a more critical role in reviewing a tobacco product SE submission, particularly for minor changes in tobacco product design or manufacture. FDA should consider adding categorical exclusions for certain tobacco product submissions.
Under the Tobacco Control Act, FDA can not issue a regulation “banning all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little cigars, all pipe tobacco, or all roll-your-own tobacco products.” The longer these CTP SE reviews drag on, the greater the perception that a “ban” on new products is exactly what is happening.