The appearance of counterfeit products in the drug supply chain has created challenges for the health care industry, law enforcement, and especially pharmaceutical and biotech therapeutic drug manufacturers, many of whom did not fully appreciate this threat just 10 years ago. This article summarizes a number of issues faced by manufacturers of branded medicines today and suggests some approaches from a broad biopharmaceuticals point of view that can be used to manage this new threat.
Pharmaceutical Security Institute. PSI 2005 Situation Report. February 2006:8-16.
2.
Lutter R.U.S. Food and Drug Administration. Speech before the RFID World Conference: Dallas, Texas, March 1, 2006. Available at: http://www.fda.gov/oc/speeches/2006/rfid0301.html.
3.
US Food and Drug Administration. FDA NEWS: FDA Alerts U.S. Residents to Recall of Counterfeit “Lipitor” Sold in the United Kingdom. Available at: http://www.fda.gov/bbs/topics/NEWS/2005/NEW01216.html.
4.
Authentication News. Counterfeit Drugs Issue Emerges in the U.S. 2000;6(5): 1-2.
5.
World Health Organization. Counterfeit medicines. Available at: http://www.who.int/mediacentre/factsheets/fs275/en/print.html.
6.
US Food and Drug Administration. Combating Counterfeit Drugs: A Report of the Food and Drug Administration Annual Update. Available at: http://www.fda.gov/oc/initiatives/counterfeit/update2005.html.
7.
US Food and Drug Administration. Recent FDA/U.S. customs import blitz exams continue to reveal potentially dangerous illegally imported drug shipments. Available at: http://www.fda.gov/bbs/topics/NEWS/2004/NEW01011.html.
8.
US Food and Drug Administration. Combating counterfeit drugs: A report of the food and drug administration. Available at: http://www.fda.gov/oc/initiatives/counterfeit/report02_04.html.
9.
The White House: President George W. Bush. Fact sheet: President Bush signs the Stop Counterfeiting in Manufactured Goods Act. Available at: http://www.whitehouse.gov/news/releases/2006/03/20060316-6.html.
10.
Partnership for Safe Medicines. Welcome to SafeMedicines.org. Available at: www.SafeMedicines.org.
11.
California State Board of Pharmacy. Enforcement committee meeting. Available at: http://www.pharmacy.ca.gov/meetings/agendas/06_mar_enf.pdf.
12.
US Food and Drug Administration. FDA Anti-counterfeit Drug Initiative public workshop and vendor display. Available at: http://www.fda.gov/rfidmeeting.html.
13.
US Food and Drug Administration, FDA Office of Public Affairs. Fraudulent, unapproved influenza-related products. Available at: http://www.fda.gov/fdac/features/2006/206_influenza.html.
14.
US Department of Health and Human Services. Anti-counterfeit Drug Initiative Workshop and vendor display. Vol. 71-77: 1759-1763. Available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/06-249.htm.
15.
Amgen. Comments to FDA. Available at: http://www.fda.gov/ohrms/dockets/dockets/05n0510/05N-0510-EC16-Attach-1.pdf.
16.
US Food and Drug Administration. Radiofrequency identification feasibility studies and pilot programs for drugs. November 2004. Available at: http://www.fda.gov/oc/initiatives/counterfeit/rfid_cpg.html.