FDA Week: Industry Warns Of Poor Data, Exclusion From New Tobacco Activities

A regulatory watchdog group and industry representatives are expressing concern with how a new FDA menthol advisory panel is proceeding, contending that agency data for a forthcoming report is flawed and could set the precedent for using inadequate information for other tobacco-related reports. The panel, whose members are mostly non-governmental experts, is charged with evaluating how the use of menthol in cigarettes affects smoking patterns. (emphasis supplied)

Meanwhile, non-voting industry members of the menthol subcommittee were also disappointed at being left out of the writing responsibilities for the menthol report required under recent legislation, disputing an FDA claim that the omission of their input reflects the agency’s desire to maintain trade secrets.

The Center for Regulatory Effectiveness recently filed an Information Quality Act petition to address concerns about data for writing a report on menthol that had been presented to the whole Tobacco Products Scientific Advisory Committee, questioning the agency’s statistics on cessation and initiation, the group’s Jim Tozzi said.

He added that the subcommittee’s administration will set the precedence for the entire TPSAC, which was established under the Family Smoking Prevention and Tobacco Control Act. The law, which brought tobacco regulation under FDA’s jurisdiction, requires the committee to report to HHS on menthol.

“This suggests that there are likely to be similar deficiencies in many of the other studies considered by the TPSAC or in the FDA presentation of those other studies,” according to the petition, which was filed Sept. 20. The agency has 60 days to respond.

The menthol panel held its first meeting Monday to discuss the structure of the upcoming report.

While CRE has challenged the data, it supported FDA’s decision to remove itself from the process and not write the report. Instead, the non-industry members of the subcommittee will prepare the draft report.

Because FDA said it would not be writing the report, Tozzi said it changed the tone of the meeting and stimulated more public discussion about the procedural aspects of the report. “The implication went way beyond that statement,” he said.

Prior report deliberations, he said, have not encouraged discussions about deadlines, industry participation and other procedural issues that will impact the report. The subcommittee includes seven voting members and three non-voting members from industry. It is chaired by Jonathan Samet, a professor at the University of Southern California.

“The fact that they said they aren’t going to write the report adds a lot of legitimacy to the report,” he said, adding that the outcome of the petition could also affect issues raised during the Monday (Sept. 27) menthol panel meeting.

Industry representatives were told they would not contribute to the final report, but could author their own study. John Lauterbach, of the Georgia-based Lauterbach and Associates, said the decision caught industry members by surprise. The industry representatives said they would meet by the end of the week to discuss how to proceed with their analysis.

“We were promised full participation in the menthol report writing committee,” said Lauterbach, who represents small business tobacco manufacturers.

But, an FDA spokesman said the agency never suggested that industry could participate in drafting the report. He said the industry representatives were kept from the overall analysis to maintain trade secrets.

“At no time were members of the industry told they were going to be allowed to participate in the writing of the report,” an FDA spokesman said.

Because the industry representatives are working as contractors, Lauterbach said they will focus objectively on the science. The trade secrets, he said, would not be an issue.

“At the end of the day pretty much everybody knows what everybody else is doing,” he said.–Alaina Busch

2 comments. Leave a Reply

  1. James Hill

    An amazing piece by FDA Week. I seem to remember stories in the Boston Globe and Washington Monthly about how effective the DQA is in stopping the use of flawed scientific data. I don’t care the issue; bad science is bad science.

    In particular I’m familiar with some of the cessation studies you cite in the filing. It seems the TPSAC is trying to use studies that looked only at individuals who went to cessation clinics (a tiny percentage of people who attempt to quit smoking would ever go to a clinic) and extrapolate that to the quit rates of the general smoking population. That would be a ridiculous use of otherwise good cessation clinic studies that were designed to examine the effectiveness of pharmaceutical products not to measure the quit rates of menthol cigarette smokers.

    Editors Note: Mr. Hill, you have an excellent memory regarding the DQA. With respect to using data from cessation clinics, several of the authors of the papers stated that the studies were conducted for reasons other than determining the impact menthol has on cessation but surprisingly FDA used the studies anyway.

Leave a Reply

Please Answer: *