Chairman Pitts, Ranking Member Pallone and members of the Health Subcommittee, thank you for the opportunity to present testimony. I thank you for holding this hearing and, in particular, applaud Representatives Bilbray and Matheson for introducing a bipartisan bill that would help protect Americans from counterfeit drugs.
Through research and critical analysis, the Pew Health Group seeks to improve the health and well-being of all Americans by reducing unnecessary risks to the safety of medical and other consumer products and supporting medical innovation.
The focus of my testimony today is the drug distribution system – the risks of counterfeit and stolen drugs, and the pragmatic steps Congress can take to reduce those risks.
In July of 2011, Pew released a report entitled “After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs.”1 The report, which underwent extensive external review, was based upon information from regulatory and public documents, peer-reviewed journal articles and interviews with dozens of supply chain experts from numerous perspectives. It was informed by a two-day conference we hosted in March 2011 that included representatives of brand and generic pharmaceutical manufacturers, active drug ingredient makers, major and secondary pharmaceutical wholesalers, chain and independent pharmacies, consumer and health professional organizations, the U.S. Food and Drug Administration (FDA), state regulators and independent supply chain experts.
1 Pew Health Group. “After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs.” (2011) http://www.prescriptionproject.org/after_heparin_report
2 United States Attorney's Office, Southern District of Florida. Three Indicted for Diversion of Prescription Drugs Press Release. March 18, 2010. http://www.justice.gov/usao/fls/PressReleases/100318-01.html, Accessed October 20, 2010.
3 U.S. Food and Drug Administration. Update to FDA Alert About Stolen Insulin. August 26, 2009. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm180320.htm. Accessed November 12, 2010.
4 Ciolek, Michelle M., Special Agent, Office of Criminal Investigations, U.S. Food and Drug Administration. Affidavit in support of search warrant. July 21, 2009. USA v. Altec Medical Inc and RX healthcare Inc. Document number: 8:09-cr-00814-WMC
5 Forsaith, Chuck. Corporate Director, Supply Chain Security, Purdue Pharma L.P. “Cargo Theft.” Presentation, 2010 PDA/FDA Pharmaceutical Supply Chain Workshop. Bethesda, MD. April 26-28, 2010.
6 Serono, Inc. Serostim [somatropin (rDNA origin) for injection]. Press Release, January 2001. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm173895.htm. Accessed February 17, 2011.
7 Otto, Alex. Counterfeit Serostim Found Nationwide. Pharmacy Today. American Pharmacists Association. March 1, 2001. http://www.medscape.com/viewarticle/406804. Accessed October 13, 2010.
8 Dutchess Business Services Inc. v. Nevada State Board of Pharmacy. No. 46345. September 11, 2008. http://caselaw.findlaw.com/nv-supreme-court/1219556.html. Accessed February 17, 2011.
9 Williamson, Joyce P. Statement of Serono before the task force on drug importation. http://archive.hhs.gov/importtaskforce/session2/presentations/Serono.pdf, Accessed February 17, 2011.
10 Counterfeit Pharmaceutical Inter-Agency Working Group Report to the Vice President of the United States and to Congress. March 2011. http://www.whitehouse.gov/sites/default/files/omb/IPEC/Pharma_Report_Final.pdf. Accessed April 22, 2011.
11 Administration's White Paper on Intellectual Property Enforcement Legislative Recommendation