Eighty percent of the active and bulk chemical ingredients in U.S. drugs originate overseas,1 according to estimates by the Food and Drug Administration. The increasingly global and outsourced production of drugs creates vulnerabilities in the pharmaceutical supply system, which, without sufficient oversight by industry and regulators, can put patients’ lives at risk.
In early 2008, the U.S. Centers for Disease Control and Prevention identified a series of illnesses in dialysis patients, most of whom had received the blood thinner heparin.2 Investigations revealed that an adulterant with toxic effects had been introduced during heparin’s manufacture in China.3 Dozens of Americans were sickened, and some died.4
Title VII of the FDA Safety and Innovation Act of 2012 establishes new safeguards for global drug production. The law directs FDA to prioritize inspections of the highest-risk manufacturing sites, overseas and domestic, and provides the agency with important new authority, such as the ability to block the importation of a drug or ingredient if the manufacturing plant has refused or delayed an FDA inspection.5
1 U.S. Government Accountability Office, Food and Drug Administration: Improvements Needed in the Foreign Drug Inspection Program (Publication No. GAO/HEHS-98-21, March 1998), http://www.gao.gov/assets/230/225564.pdf.
2 U.S. Centers for Disease Control and Prevention, “Acute Allergic-Type Reactions Among Patients Undergoing Hemodialysis: Multiple States, 2007–2008,” Morbidity and Mortality Weekly Report (Feb. 1, 2008),http://www.cdc.gov/mmwr/preview/mmwrhtml/mm57e201a1.htm.
3 Takashi Kei Kishimoto et al., “Contaminated Heparin Associated With Adverse Clinical Events and Activation of the Contact System,” New England Journal of Medicine (June 5, 2008) 358: 2457–67; and Steve Usdin, “The Heparin Story,” International Journal of Risk and Safety in Medicine (2009) 21: 99–103.
4 U.S. Government Accountability Office, Food and Drug Administration: Response to Heparin Contamination Helped Protect Public Health; Controls That Were Needed for Working With External Entities Were Recently Added (October 2010, Publication No. GAO-11-95) http://www.gao.gov/assets/320/311879.pdf.
5 U.S. Food and Drug Administration, “FDASIA Title VII Drug Supply Chain Provisions,” http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm365919.htm.