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Recent Withdrawals

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Title: Developing Consumer Marketing Claims within the Clinical Development Process Author: Lou Morris Created Date: 9/29/2000 3:30:09 PM Document presentation format – PowerPoint PPT presentation

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Title: Recent Withdrawals


1
Recent Withdrawals
  • Seldane? (terfenadine) 2/98
  • Posicor ? (mibefradil) 6/98
  • Duract ? (bromphenac) 6/98
  • Hismanal ? (astemizole) 6/99
  • Roxar ? (grepafloxacin) 11/99
  • Propulsid ? (cisapride) 3/23/00
  • Rezulin ? (troglitazone) 3/21/00
  • Lotronex ? (alosetron HCl) 8/24/00
  • Raplon ? (rapcuronium) 3/01
  • Baycol ? (cerivaxtatin) 8/8/01
  • Vioxx ? (rofecoxib) 9/30/04

92 NMEs from 1998-2000
2
Rezulin Withdrawal
  • FDA took this action after its review of recent
    safety datashowed that Rezulin is more toxic to
    the liver than the other two drugs HHS News,
    3/21/00
  • And weve had to withdraw drugs from the market
    that would have been safe if used according to
    label instructions Janet Woodcock, Temple
    University, 4/4/00

Not to mention the pain in the pain reliever
market
3
Top 20
4
FDA RM Guidances
  • Concept Papers, March 2003
  • Hearings April 2003
  • Draft Guidances, May 2004
  • Final Guidances, March 2005
  • Premarketing Risk Assessment
  • Development and Use of Risk Minimization Action
    Plans (RiskMAPs)
  • Good Pharmacovigilance Practices and
    Pharmacoepidemiologic Assessment

5
Questions About the New Era
  • What is the responsibility for a company when it
    comes to a new (or old) drug?
  • Labeling, PMS, how it is used, even if used
    incorrectly?
  • Risk Perception what is know to science, what
    is know to user, what is controllable?
  • How safe must a drug be before it is marketed?
  • Safer than other drugs in the class?
  • How many (what size) studies must be done?
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