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Counterfeit Drugs

What is the danger of counterfeit drugs?

Tim Fagan's Law

Rep Israel calls for higher penalties  for  the sale or prescription of counterfeit drugs

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.

 

Rep. Israel and the Fagan family speak out against counterfeit drugs

In October 2003, Rep. Israel first met with the Fagan family to announce initial legislation designed to halt the prevalence of counterfeit drugs.

 

FDA Reports

Combating Counterfeit Drugs (02/18/04) PDF

The Prescription Drug Marketing Act- Report to Congress (06/01)

Counterfeit DrugsIn 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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