Center for Regulatory Effectiveness Asks from FDA Transparency

Tobacco World

 The watchdog group Center for Regulatory Effectiveness (CRE) today launched an initiative to bring sunlight and transparency to the Food and Drug Administration’s tobacco advisory committee examining the potential regulatory efforts surrounding menthol cigarettes, dissolvable tobacco products and other issues.  As to the broader issue of governance, the tobacco advisory committee is an operating arm of FDA, not an ad hoc committee of experts who render advice on select issues assigned by a regulatory agency and as such should be transparent and accountable to the public.

 Through the launch of a new Web-based Interactive Public Docket (IPD), members of the public will now be able to voice their support or concern about the work of a government panel that is currently looking into the regulation of tobacco products. The IPD will allow the public to weigh in on the FDA’s Tobacco Products Scientific Advisory Committee hearings and activities since the panel has refused to have an open process where the public could participate.

 “The FDA is closely examining issues that directly affect the public, while at the same time it is not allowing for the public to meaningfully and continually contribute to the dialogue,” said Jim Tozzi, Member, Board of Advisors, of the CRE. “The IPD will allow the FDA, the scientific committee, the Congress, and others to actively participate with each other in plain sight.  It is an essential that this process be as transparent as possible.”

 The FDA established the Tobacco Products Scientific Advisory Committee (TPSAC) as part of the Family Smoking Prevention and Tobacco Control Act, signed into law by President Obama in 2009.  Its role is to serve as an advisory committee to give advice on nearly every major element of tobacco production and use.  To this end, the advisory committee is an operating arm of FDA, not an ad hoc committee of experts who render advice on select issues assigned by a regulatory agency.

 An Interactive Public Docket (IPD) provides the public a forum to communicate to federal advisory committee members.  The objective of the IPD is to make the advisory committee’s operations as transparent as possible in keeping with President Obama’s Open Government Directive.  To ensure a fair debate, users can post comments anonymously if they wish.

 The IPD has several key components, in which any member of the public can both read and post information within:

        .   A home page that includes a description of the most significant events affecting the committee.

  • The Governance and Data Quality Compliance forum, which highlights how the advisory committee operates and whether it complies with the Data [Information] Quality Act.
  • The Member Statements forum, which highlights and discusses relevant statements by members of the advisory committee.
  • The Studies and Concepts Under Review forum, which includes in-depth analyses and commentary on the scientific issues that are intended to drive the committee’s decision making in tobacco regulation.
  • The TPSAC News forum that contains current information on the activities of TPSAC.

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