Importation: Learn More About Studies on Safety

Many different groups have highlighted the serious safety concerns associated with currently imported pharmaceutical products, foremost among them, the U.S. Dept. of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA). A number of the studies and articles on safety and viability of importation are presented below.

• Report on Prescription Drug Importation - U.S. Dept. of Health and Human Services (HHS), December 2004
  This comprehensive report represents an exhaustive review of current information about the safety of pharmaceutical importation to the U.S. and whether importation would benefit U.S. consumers. The report concludes that importation of pharmaceuticals is not safe, and that there would be little cost-savings for consumers associated with importation.
  • Download the Report
• Imported Drugs Raise Safety Concerns - FDA Consumer magazine
  This article published in the Sep.-Oct. 2002 issue of FDA Consumer magazine highlights the dangers of unapproved drugs that come into the United States from foreign countries.
  • View the Article
• Canadian Prescription Drug Re-Importation: Is There a Safety Issue? - Statement of William K. Hubbard, FDA Associate Commissioner for Policy and Planning, before the U.S. House of Representatives Committee on Government Reform, June 2003
  These are statements from William K. Hubbard, Associate Commissioner for Policy and Planning at the U.S. Food and Drug Administration, before a June 2003 congressional hearing on importation of pharmaceuticals from Canada. In his remarks, Hubbard notes that the FDA is currently ill-equipped to deal with the safety issues surrounding importation, and that it cannot guarantee the safety of imported drugs.
  • Read the Statements
• Combating Counterfeit Drugs: A Report of the Food and Drug Administration - FDA, February 2004
  The actions described in this report are based on the work of an internal FDA Counterfeit Drug Task Force, which was formed in July 2003 by Commissioner of Food and Drugs with the goals of preventing counterfeit drugs and biologics from entering the U.S. drug distribution chain, facilitating the identification of counterfeit drugs and biologics, and other related aims.
  • View the Report
• Consumer Education: What You Should Know About Buying and Using Drug Products - FDA Center for Drug Evaluation and Research, Updated April 2004
  • Ensuring Safe Use of Medicines
  • Buying Medicines
  • Misuse of Medicines
• FDA/U.S. Customs Import Blitz Exams Reveal Hundreds of Potentially Dangerous Imported Drug Shipments - FDA Press Release September 2003
  A recent series of spot examinations of mail shipments of foreign drugs to U.S. consumers conducted by the Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) revealed that these shipments often contain dangerous unapproved or counterfeit drugs that pose potentially serious safety problems. The findings of these "blitz" examinations are discussed in this FDA press release.
  • Read the Press Release

Last Updated September 2007