Dr. Michael Siegel’s Comment on CRE’s Statement that FDA is Violating FACA

Center for Regulatory Effectiveness Charges that TPSAC Tobacco Product Constituents Subcommittee Violates the Federal Advisory Committee Act

In an August 29 memorandum, the Center for Regulatory Effectiveness (CRE) charges that the Tobacco Product Constituents Subcommittee of the Tobacco Products Scientific Advisory Committee (TPSAC) is acting in violation of the Federal Advisory Committee Act (FACA) because the Subcommittee is structured so as to be unduly influenced by the FDA.

The TPSAC is an advisory committee to the FDA set up under the Family Smoking Prevention and Tobacco Control Act. One of its initial charges is to develop a list of hazardous constituents in tobacco smoke in order to guide the development of “safety standards” to make cigarettes safer by removing or reducing the levels of various toxic components. To accomplish this task, a subcommittee was formed.

According to the CRE memorandum: “the FDA has not established any guidelines to assure that the recommendations of the Subcommittee will not be inappropriately influenced by the FDA. In contrast, it seems the Subcommittee was established to achieve this very result—to be unduly influence by the FDA. The Subcommittee consists of fourteen members. Three of the members of the Subcommittee are currently employed by the FDA and six members are employees of the Federal Government. Furthermore, of the fourteen members of the Subcommittee, only one member is a voting member of the parent committee, TPSAC. Given the composition of the Subcommittee, it is quite difficult to find how any report or recommendation of the Subcommittee would not be inappropriately influenced by the FDA. The operation of the Subcommittee undermines the very independent judgment and expertise that Congress intended advisory committees to provide to executive agencies when it passed FACA.”

The second charge made by CRE is that the membership of the Subcommittee violates FACA’s requirement that the membership of advisory committees be “fairly balanced” in terms of the points of view represented in light of the functions to be performed. The memorandum argues that: “the Subcommittee is not “fairly balanced” because it is overrepresented by the FDA and the federal government. The overrepresentation by the FDA and the Federal government undermines the very spirit of FACA that Congress intended. By passing FACA, Congress intended to provide for advisory committee that were transparent, independent, and balanced that could provide agencies with technical expertise. FACA did not envision advisory committees that would rubberstamp agency policies, which is the very danger posed by the overrepresentation of the FDA on the Subcommittee. While Congress has provided little guidance on the metric of what constitutes fairly balanced, it is clear that the composition of the Subcommittee does not meet the fairly balanced requirement.”

The memorandum concludes: “In sum, as a subcommittee, the Tobacco Product Constituents Subcommittee clearly falls under the definition of an “advisory committee” governed by FACA. As an advisory committee governed by FACA, the Subcommittee has been improperly established and has been operating in violation of FACA. Your response is requested not later than October 15, 2011.”

The Rest of the Story

I have to admit that I was quite surprised when I learned of the Subcommittee’s membership. I had assumed that like most subcommittees, this one would be a subset of TPSAC members designated to review the tobacco constituents. I was surprised when I read the CRE memo and learned that only one voting TPSAC member is on the Subcommittee and that three government officials and three FDA officials took part in the proceedings.

I tend to agree that with three FDA officials at these subcommittee meetings, it gives the Agency an undue influence on the proceedings. To truly be an advisory committee, the FDA itself shouldn’t really serve on the committee or on any of its subcommittees. I certainly understand the value of having an FDA official present at the meetings to serve as a conduit for information in both directions, but what CRE describes above does seem a bit excessive.

While I appreciate CRE’s concerns, I frankly am more concerned about the conflicts of interest of the members chosen to serve on the TPSAC. That, I believe, violates FDA’s own standards for advisory committee membership and precludes the possibility of unbiased science being the driving force behind the committee’s deliberations.

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    Siegel Bio


    Michael is a physician who completed his residency in Preventive Medicine at the UC Berkeley School of Public Health and trained in epidemiology for two years at the Centers for Disease Control and Prevention in Atlanta before coming to Boston. His primary research interest is in the area of tobacco control, focusing on secondhand smoke health effects, exposure, and policies, cigarette advertising and marketing practices and their effects on youths, and evaluation of tobacco control policies and their impact on youth and adult smoking behavior. His primary teaching is in the areas of mass communication, marketing, and public health advocacy. He is co-author of a book, entitled “Marketing Public Health: Strategies to Promote Social Change,” that grew out of his teaching experience at the School. He has been active in promoting smoke-free bar and restaurant policies throughout the country and has served as an expert witness in several major tobacco litigation cases.

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