A new federal law, the Drug Supply Chain Security Act, passed in 2013, will help protect patients by better securing our nation’s pharmaceutical supply chain.1
The U.S. drug supply is among the world’s safest, but troubling deficiencies and risks persist. For example, several times in 2012 and 2013, the Food and Drug Administration informed doctors’ offices and clinics that they may have purchased counterfeit vials of the cancer drug, Avastin.2 The fake products, which contained no active ingredient, came from foreign sources and passed through a series of intermediaries, including at least one licensed U.S. wholesaler.3 It is unknown how many cancer patients received these products. In 2014 two individuals were charged with obtaining unapproved, adulterated, and counterfeit cancer prescription drugs and smuggling them into the United States.4
Counterfeit drugs are not the only threat: stolen, diverted, and contaminated medicines have all been found on the U.S. market as recently as 2014.5
To improve safety, the Drug Supply Chain Security Act will:6
Between now and 2023, there will be opportunities to include additional features—such as automatic checks of transaction information and routine verification of package serial numbers—that can further improve detection of illegitimate medicines before they reach patients. Automating these features might also lower costs by reducing expenses associated with labor and human error.7
1 Title II of the Drug Quality and Security Act of 2013, H.R. 3204, 113th Cong. (2013).
2 “Counterfeit Version of Avastin in U.S. Distribution,” U.S. Food and Drug Administration, accessed May 1, 2014, http://www.fda.gov/drugs/drugsafety/ucm291960.htm;“Altuzan (bevacizumab): Counterfeit Product—Contains no Active Ingredient,” U.S. Food and Drug Administration, accessed May 1, 2014, http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/ucm338283.htm; “Another counterfeit cancer medicine found in U.S.—Illegal practice puts patients at risk,” U.S. Food and Drug Administration, accessed May 1, 2014, http://www.fda.gov/drugs/drugsafety/drugintegrityandsupplychainsecurity/ucm298047.htm; “Health Care Provider Alert: Another Counterfeit Cancer Medicine Found in United States: Purchasing Unapproved Drugs is Risky Business,” U.S. Food and Drug Administration, accessed May 1, 2014, http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/ucm338283.htm.
3 “Counterfeit Version of Avastin in U.S. Distribution,” U.S. Food and Drug Administration.
4 “Two Turkish Nationals Indicted for Smuggling Counterfeit Cancer Drugs,” United States Attorney’s Office, Eastern District of Missouri, press release. Jan. 16, 2014, http://www.fda.gov/ICECI/CriminalInvestigations/ucm383001.htm.
5 “FDA Conducts Preliminary Review of Agency’s Diversion and Counterfeit Criminal Case Information,” U.S. Food and Drug Administration, accessed May 1, 2014, http://www.fda.gov/downloads/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/UCM272150.pdf.
6 U.S. Food and Drug Administration website, “Drug Supply Chain Security Act (DSCSA),” accessed May 1, 2014, http://www.fda.gov/drugs/drugsafety/drugintegrityandsupplychainsecurity/drugsupplychainsecurityact/default.htm.
7 PWC (formerly Booz & Company), “Next-Generation Supply Chains: Efficient, Fast and Tailored” (2012), http://www.pwc.com.uy/es_UY/uy/publicaciones/assets/pwc-global-supply-chain-survey-2013.pdf.