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Consumer Demand Conference Potential FDA Regulation

Consumer Demand Conference Potential FDA Regulation. Mitch Zeller Pinney Associates May 4, 2007. Past Legislative/Regulatory Efforts. 1996: FDA assertion of jurisdiction Overturned by U.S. Supreme Court in 2000

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Consumer Demand Conference Potential FDA Regulation

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  1. Consumer Demand ConferencePotential FDA Regulation Mitch Zeller PinneyAssociates May 4, 2007

  2. Past Legislative/Regulatory Efforts • 1996: FDA assertion of jurisdiction • Overturned by U.S. Supreme Court in 2000 • 1997/1998: Provisions in proposed settlement of state lawsuits requiring legislative codification • Resulted in McCain bill • A divided public health community • Collapsed under its own weight on Senate floor • 2004/2005: Kennedy/DeWine and farmer buy-out “marriage of convenience” • Buy-out passed; FDA failed

  3. Current Legislative Effort • Essentially same bill as Kennedy/DeWine • Vastly different political environment • Democratic control of House and Senate • Supported by broad coalition of public health groups (and Philip Morris) • Views of Bush Administration not known

  4. Key Provision Related to Treatment • Non-binding language that urges FDA to take a more flexible approach to the review of NRT, including: • Fast track evaluation and approval • Extended duration of use • Additional indications, including craving relief and relapse prevention • Will serve as platform to call attention over time to Congress' intent • Can be used as reason for ongoing Congressional scrutiny of FDA behavior if agency continues “business as usual” approach • Does not guarantee a change in agency behavior, but has worked in the past with FDA

  5. Key Provisions on Tobacco • Pre-market evaluation of any express or implied health claim for tobacco products under rigorous scientific standards • Ban the use of “light” and similar descriptors • Authorization for warning labels on up to 50% of the front and back package panels

  6. Prospects for Passage • Conventional wisdom puts it as high as 50/50 • No target date for passage • Senate mark-up scheduled for April 25 postponed until late May/early June • House action not yet underway

  7. Implications • Passage of the bill will “level the playing field,” especially if FDA honors the language regarding treatment • Rigorous pre-market evaluation of tobacco health claims minimizes chances of a repeat of the “lights” public health disaster • Two generations of would-be quitters were lost to the false promise of “lights”

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