Quality Safety of Generic Drugs in the World Market

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					Quality & Safety of Generic Drugs
       in the World Market
                World Bank Conference
                “Good Intentions – Bad Drugs”
                March 10, 2005
                Washington, D.C.
                Christine Simmon
                VP, Public Affairs & Development
                Generic Pharmaceutical Association
GPhA: Who We Are

   The organization representing the entire generic
    drug industry
     – Single, unified voice to FDA, legislators, public
     – >140 members
          Manufacturers, API suppliers, CROs, others
     – Members produce >98% of generic drugs sold in
       the U.S.
Counterfeit & Substandard Products: A
Growth Industry

   FDA counterfeiting investigations have increased
    400% over the last several years.
   Global problem
    –   WHO estimates counterfeits comprise 5-8% of world market
    –   WHO survey found 60% of counterfeit medicine cases
        occurred in poor countries; 40% in industrialized countries.
   Factors Driving Counterfeiting:
    –   Economic Factors
    –   Weaknesses in the drug distribution system
    –   Importation of unregulated medicines
    –   Internet pharmacies
Quality is Paramount

   Substandard Medicines Concern Brand & Generic Sectors
    –   Mislabeling
    –   Fraudulent packaging
    –   Subpar ingredients
   Adverse Health Consequences
    –   Emerging resistance for infectious diseases
    –   Inadequate treatment
    –   Death
   Adverse Economic Consequences
    –   WHO estimates sales of counterfeit medicines at US $32 billion
        annually
Setting Standards

   FDA
   USP
   Competent Regulatory
    Authorities/Counterparts
Systemic Problem, Systemic Solutions

   Governmental approaches
    –   Regulation
    –   Enforcement
    –   Global Information Exchange
    –   Education
   Implicates all parts of the drug distribution chain
    –   API Suppliers
    –   Manufacturers
    –   Wholesalers
    –   Distributors
GPhA: Partnering In Quality Assurance
Worldwide

   FDA RFID & Other Measures
   USP International Monograph
   WHO’s Counterfeiting & Drug Quality
    Working Group/IGPA
   U.S. Department of Commerce
   CUMVIVIUM
            Thank You!
           Christine Simmon
Vice President, Public Affairs & Development
    Generic Pharmaceutical Association
     703-647-2494; 703-647-2481 (fax)
         csimmon@gphaonline.org
      2300 Clarendon Blvd., Ste. 400
            Arlington, VA 22201