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REP. ISRAEL CALLS ON THE FDA TO MOVE BEYOND RHETORIC AND TOWARD SECURING THE SAFETY OF AMERICA'S DRUG SUPPLY

AS FDA BEGINS PUBLIC WORKSHOP ON RFID TECHNOLOGY AND COUNTERFEIT DRUGS, ISRAEL URGES HIS COLLEAGUES TO PASS GROUNDBREAKING LEGISLATION

02/08/06 Washington, DC-Congressman Steve Israel (D-NY-02), the sponsor of legislation to combat the threat of counterfeit prescription drugs, responded today to the FDA's pubic workshop on the use of Radio-Frequency Identification (RFID) technology to provide for the track-and-trace of prescription drugs. It is widely believed that RFID technology has the capability of providing "e-pedigrees" that show the previous buyers and sellers of a prescription drug, but the technology is complicated and it may be years before its use on prescription drugs is possible. Federal law mandates drug "pedigrees" that would track the path of prescription drugs from production to point of sale, but the FDA has placed a stay on their implementation since 1987.

"What Americans don't know is that in between the manufacturer and pharmacy, prescription drugs can change hands up to a dozen times where they can be tainted, diluted, relabeled and counterfeited," Israel said. "That's why, as members of Congress, we have a responsibility of taking a comprehensive approach to securing our nation's drug supply. We need to do more than simply hold a workshop, Congress needs to pass 'Tim Fagan's Law,' which calls for pedigrees and gives the FDA the tools it needs to fight this growing epidemic."

In 2002, after Israel's 16-year old constituent Tim Fagan underwent a liver transplant, Tim's parents purchased prescription drugs at a major pharmacy; however, the drugs they purchased, which he was injected with for weeks, turned out to be counterfeit. The current distribution system for prescription drugs has significant loopholes that allow criminals to introduce counterfeits into our drug supply that reach reputable pharmacies.

Last May, Israel introduced groundbreaking legislation "Tim Fagan's Law" that gives the FDA the authority to recall drugs; implement harsher penalties for criminals who pawn fake medicine off on innocent consumers, and requires paper pedigrees. Since the introduction of Israel's legislation in May, all of the so-called Big Three wholesalers have pulled out of the secondary market. Additionally, CVS has announced it will not buy drugs from those that engage in the secondary market.

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