Testimony of Allan Coukell on the Lack of a National Pharmaceutical Tracking System
Testimony before the House Committee on Energy and Commerce, Subcommittee on Health
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.
Download the PDF to read the complete testimony from Alan Coukell.
- Date added:
- Mar 8, 2012
- Project:
- Drug Safety Project
- Topics:
- Drug Manufacturing and Distribution, Drug Safety
- Related Expert:
- Allan Coukell
- References:
- Collapse All
close
1 Pew Health Group. “After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs.” (2011) http://www.prescriptionproject.org/after_heparin_reportReferences:
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 Recommendatio
Related Resources
''Drug Manufacturer Agrees to $500 Million Penalty''
''A subsidiary of India's largest pharmaceutical company has agreed to pay a record $500 million in fines and penalties for selling adulterated drugs and lying to federal regulators in a case that is part of an ongoing crackdown on the quality of generic drugs flowing into the U.S."
More info''Community Pharmacies Will Now Back Supply Chain Legislation''
"As differing bills for securing the pharmaceutical supply chain wind their way through the US House and Senate, a key hurdle to passing legislation may have just been cleared. Earlier this week, the National Community Pharmacists Association – which is a member of an influential industry coalition that has been floating its own proposals – is now willing to back either bill."
More info''Senators Say They Are Close to Writing a Final Pharmacy Compounding Bill''
"U.S. senators considering fundamental changes to how the practice of pharmacy compounding is regulated heard almost unanimous support for reform at a Washington committee hearing Thursday."
More info''Senate Moves Closer to Law to Prevent More Pharmacy Outbreaks''
"At least 67 people have died in 20 outbreaks caused by contaminated drugs since 2001, experts told a Senate hearing Thursday. The Food and Drug Administration says there have likely been more cases than that, but they have no way of telling now."
More info
