Quality & Safety of Generic Drugs in the World Market

World Bank Conference“Good Intentions – Bad Drugs” March 10, 2005Washington, D.C.Christine SimmonVP, Public Affairs & DevelopmentGeneric 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 & DevelopmentGeneric Pharmaceutical Association703-647-2494; 703-647-2481 (fax)

csimmon@gphaonline.org2300 Clarendon Blvd., Ste. 400

Arlington, VA 22201