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Counterfeit Drugs
What is the danger of counterfeit drugs?
Tim
Fagan's Law |
On May 9, 2005, Rep. Israel
announced the introduction of Tim Fagan's Law, which
seeks to to increase criminal penalties for the sale
or trade of counterfeit prescription drugs; to modify
requirements for maintaining records of the chain-of-custody
of prescription drugs; and to establish recall authority
for the FDA. |
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In October 2003, Rep.
Israel first met with the Fagan family to announce initial
legislation designed to halt the prevalence of counterfeit
drugs. |
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In
2002, my 16-year old constituent, Tim Fagan, underwent a liver transplant.
While recovering from the transplant, he was taking the drug Epogen,
in order to fight his related anemia. His parents bought the Epogen
from the local branch of a reputable, nationwide pharmacy. In order
to help her son, his mother dutifully injected the Epogen into his
arm. After waking up in pain many nights in a row and not knowing
why, the family received a telephone call. The Epogen that his mother
had been injecting to help her son recover was counterfeit.
Counterfeit drugs have become a bigger problem in the last few
years. In 2003, the public learned that the popular cholesterol
drug Lipitor was counterfeited and 200,000 bottles were recalled.
The same year, Procrit, which is another drug to treat anemia, was
found to be counterfeited. Procrit was selling at $500 a vial, which
raises the interest of criminals because of the potential profit
involved.
There are many opportunities for counterfeiters to enter the American
pharmaceutical distribution system. More than half of all drugs
go through a series of wholesalers. The drugs go from the manufacturer
to a large wholesaler, then through a number of smaller wholesalers,
until it finally gets to the local pharmacy.
What is Rep. Israel doing to counter this threat?
In May 2005, Rep. Israel introduced legislation to increase criminal
penalties for the sale or trade of counterfeit prescription drugs;
to modify requirements for maintaining records of the chain-of-custody
of prescription drugs; and to establish recall authority for the
FDA. The legislation is titled Tim Fagan's Law (H.R. 2345).
What does Tim Fagan's Law do?
• Give the FDA recall ability, in the same way that the FDA
can recall faulty equipment;
• Increase criminal penalties for counterfeiting;
• Mandate that drug manufacturers must alert the FDA in
2 days when they learn that one of their drugs has been counterfeited;
• Authorize funds specifically for spot-checking ($300 million
over 5 years);
• Implement the safeguards outlined in Combating
Counterfeit Drugs: A Report of the Food and Drug Administration;
• Require the FDA to remove the stay placed on paper pedigrees,
which were mandated in the Prescription Drug Marketing Act of 1988.
Counterfeit Drug News from Congressman Israel
February 2006
Rep. Israel Calls on the FDA to
Move Beyond Rhetoric and Toward Securing the Safety of America's
Drug Supply
(02/08/2006)
November 2005
Rep. Israel, Author of Groundbreaking
Legislation, Introfuces Counterfeit Drug Victim at Congressional
Hearing (11/01/05)
May 2005
Rep. Israel Cites News
of CVS Severing Ties with Secondary Wholesalers as Renewed Call
to Pass Legislation Stopping Counterfeit Prescription Drugs
(05/24/05)
Israel Announces Groundbreaking
Legislation, "Tim Fagan's Law," to Fight Counterfeit Prescription
Drugs (05/09/05)
Legislator
Trying To Stop The Sale Of Counterfeit Drugs (WCBS-TV 05/09/05)
October 2003
Rep. Steve Israel Introduces
Legislation to Fight Counterfeit Prescription Drugs (10/10/03)
Related Counterfeit Drug Web Links
United
States Food & Drug Administration Counterfeit Drugs Webpage
(FDA)
The
Full Report from the Food & Drug Adminstration on "Combating
Counterfeit Drugs" (FDA)
Dangerous Doses: An
investigative reporter's look into the world of counterfeit prescription
drugs.
The Turkewitz Law Firm
Counterfeit Drug Resource Page
Protect Yourself From Counterfeit
Drugs: (The National Consumers League)
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