Drug Supply Developments

2008

› In April, in a move to create uniform federal standards for the tracking of prescription drugs that would supplant individual state initiatives, Representatives Jim Matheson (D-UT) and Steve Buyer (R-IN) introduced the Safeguarding America's Pharmaceuticals Act (H.R. 5839). To read the bill, click here.

› In March, the California's Board of Pharmacy voted to again delay implementing a state plan requiring electronic pedigrees for all prescription drugs as they move through the supply chain, beginning with the manufacturers. The new effective date will be 2011 (originally 2007). To read the full decision, click here. To read an article about pedigree regulation, click here.

2007

› By December, 26 states took steps to protect the drug supply, passing laws or regulations that restrict wholesale licenses and required pedigrees.

› In September, the federal government passed the Food and Drug Administration Amendments Act of 2007, to "develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs." To read a summary of the law, click here. To read the full text, click here.

2006

› On December 26, Attorney General Eliot Spitzer announced an agreement with Cardinal Health Inc. stating that the company will no longer buy pharmaceuticals on the secondary market. This agreement helps to establish a new standard for safety within the pharmaceutical industry. To read the press release, click here.

› The FDA announced it will implement 18-year-old regulations requiring drug pedigrees in either paper or electronic form. New technologies will continue to be developed and implemented, such as radio-frequency identification (RFID), that electronically tracks the movement of medications through the drug supply chain. To read the full report, click here. To read the press release, click here.

› On December, a U.S. District Court in New York sided, in part, with secondary wholesalers, granting their request to halt implementation of the FDA's drug pedigree regulations or so-called "final rule." To read the court order, click here.

2005

› On November 11, McKesson Corporation told Kevin Fagan that it would no longer buy pharmaceuticals from secondary sources. "...on a going forward basis, [drugs] will only be purchased directly from the manufacturer or from the manufacturer's designated sole distributor," McKesson General Counsel Ivan D. Meyerson wrote to Fagan. With this decision, the nation's three largest pharmaceutical wholesalers have pledged to stop buying brand-name pharmaceuticals from secondary wholesalers, the Wall Street Journal reports.

› On November 1, Katherine Eban testified in the hearings "Sick Crime: Counterfeit Drugs in the United States," before the U.S. House of Representatives, Committee on Government Reform, subcommittee on Criminal Justice, Drug Policy, and Human Resources. To watch the hearing, click here, then click on the link “House Hearing on Counterfeit Drugs,” or click here to read the transcript. For the written testimony, click here.

› On September 22, AmerisourceBergen announced that it would stop buying prescription drugs from secondary wholesalers for its U.S. consumers. Click here to read the press release.

› On August 7, U.S. Senator Chuck Schumer (D-NY) stood with Tim Fagan and his parents and announced federal legislation to crack down on counterfeit medicine. Click here to read the press release.

› CVS announced that it will stop doing business with pharmaceutical wholesalers who buy drugs from the secondary market. USA Today cites Dangerous Doses in an article on CVS's decision.

› On May 9, Rep. Steven Israel (D-NY) stood with Katherine Eban and announced federal counterfeit-drug legislation, Tim Fagan’s Law named after the Long Island teenager who received counterfeit Epogen after a liver transplant.

› On May 5, Cardinal Health announced it would close a pharmaceutical trading division that buys drugs from secondary wholesalers. The Wall Street Journal cited Dangerous Doses as an impetus.

› In April, New York State Attorney General Eliot Spitzer launched an investigation into the buying practices of the nation’s largest pharmaceutical wholesalers, Cardinal Health, AmerisourceBergen and McKesson.