231653 Can the FDA be an International Police Force?

Tuesday, November 9, 2010 : 9:42 AM - 10:00 AM

R. Cherie Robertson, PharmD , International Health Department, Tulane University School of Public Health and Tropical Medicine, Baton Rouge, LA
Jessica Charles, MPH , Social Sectors Development Strategies, Inc., Boston, MA
Maggie HuffRousselle, PhD, MBA, MA , Social Sectors Development Strategies, Inc., Boston, MA
One proposed solution to rising US healthcare costs is to legalize reimportation of branded medications and regulate internet pharmacies operating outside of the US. The FDA is under pressure to address the logistics of reimportation, but the Agency is not prepared to support prescription drug reimportation yet. With contaminated medications entering the US supply chain (e.g. the 2008 contaminated blood thinner from China linked to 80 US deaths), limited regulation of international manufacturing practices, and the growing number of counterfeit medications entering the US, the FDA already has serious problems to address before tackling reimportation. The FDA has limited jurisdiction over international wholesalers and manufacturers where many of the medications used in the US originate. Americans once used drugs that were mostly manufactured domestically. Now up to 40% of the drugs we take are imported, and up to 80% of the active pharmaceutical ingredients in the drugs we use are imported. A 2007 law gave the FDA more power to crack down on safety hazards of drugs that have reached the market. With that law, the FDA has expanded its presence in foreign countries by opening offices in India, China, Africa/Asia, Latin America, Europe, and the Middle East to better oversee imported products. This presentation discusses the implications of FDA international jurisdiction and the global public health threat of an uncontrolled medication supply chain.

Learning Areas:
Provision of health care to the public
Public health administration or related administration
Public health or related laws, regulations, standards, or guidelines
Systems thinking models (conceptual and theoretical models), applications related to public health

Learning Objectives:
Explain the US medication supply chain and the origin of ingredients used in medicines Discuss jurisdiction concepts for regulating medications both domestically and internationally and the role of other regulating agencies such as WHO- IMPACT and NAFDAC Describe the FDAs previous role in drug safety and monitoring and discuss the expanded regulatory role as indicated in the 2007 FDA Amendments Law

Keywords: Consumer Protection, Drug Safety

Presenting author's disclosure statement:

Not Answered

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