Telling the Public Health Story to the FDA

Audience: Staff from state and local tobacco control programs and non-government organizations.

Key Points: For the federal regulatory process to function effectively, there must be active public involvement.  The tobacco industry will respond to every formal request for comments and information published by the FDA.  Their responses will be exhaustive, persuasive, and totally one-sided: the best that money can buy.  In the absence of a robust public health response, the record on which the FDA must act will be tilted away from the public health and FDA will find it more difficult to act boldly or defend its actions in court.   Unfortunately, many members of the public health community still do not fully understand the federal regulatory process, the procedure for interacting with FDA as a regulatory authority, or the types of information and evidence that will allow the FDA to act decisively.  This session will give the public health community this understanding.

Educational Experience: Campaign and Consortium staff will present a brief overview of the federal regulatory process, emphasizing its application in the Tobacco Control Act.  We will also discuss the fact that submitting comments to the FDA does not constitute lobbying, a fact not always understood by the public health community.  Finally, we will walk the audience through the FDA’s website, show them the topics for which the agency is requesting comments, and demonstrate the agency’s online submission form.

Benefits: Participants will leave with a better understanding of the federal regulatory process and how their stories can influence federal regulation.