[Congressional Record (Bound Edition), Volume 151 (2005), Part 7]
[Extensions of Remarks]
[Pages 9629-9630]
[From the U.S. Government Publishing Office, www.gpo.gov]




                THE INTRODUCTION OF ``TIM FAGAN'S LAW''

                                 ______
                                 

                           HON. STEVE ISRAEL

                              of new york

                    in the house of representatives

                         Thursday, May 12, 2005

  Mr. ISRAEL. Mr. Speaker, I rise to introduce legislation that will 
make our Nation's prescription drugs safer by making it harder for 
counterfeit drugs to enter the distribution system and increasing 
penalties for those who try.
  In 2002, a teenage constituent of mine, named Tim Fagan, learned 
first hand about the problem of counterfeit drugs in this country. He 
was recovering from a liver transplant, and was taking the drug Epogen, 
in order to fight his related anemia. His parents bought the Epogen 
from the local branch of 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 from a liver transplant was 
counterfeit.
  It is imperative that Congress does everything they can to ensure 
this never happens again. The Epogen that Tim had taken was the 
equivalent of a three-dollar bill. The medicine should have gone into 
the dumpster outside of the drug store, and not on the drug store 
shelf.
  Tim is not the only victim of counterfeit drugs.
  Counterfeit prescription drugs are becoming an increasingly severe 
problem in the United States. In the past three years, Lipitor, 
Procrit, Epogen, and Serostim have been recalled due to a prevalence of 
counterfeits. According to the Pharmaceutical Security Institute, the 
value of counterfeit, seized and diverted drugs in the United States 
was almost $200 million in 2003, seven times more than 2002. The World 
Health Organization has stated that worldwide, the counterfeit drug 
industry was worth about $32 billion in 2003.
  Counterfeit drugs may contain inactive substances like water or 
saline. They may also be re-labeled to show they have a higher dosage 
than what is actually in the vial, which leads patients to take much 
less medicine than is required. They may also contain wrong ingredients 
or contaminants. Since people taking these counterfeited drugs are 
already sick, it is harder for fakes to be detected. Victims of 
counterfeiting may believe that they are just not getting better or the 
worsened symptoms are an effect of their illness and not counterfeited 
drugs.
  There are many opportunities for counterfeiters to enter the American 
pharmaceutical distribution system. New York State Attorney General 
Eliot Spitzer recently subpoenaed the three largest wholesales, 
AmeriSourceBergen, McKesson, and Cardinal Health. However, there are 
about 12 large regional wholesalers and an estimated 6,500 smaller drug 
wholesalers.
  More than half of all drugs go through this series of middlemen. The 
drugs go from the manufacturer to a large wholesaler, then through a 
number of smaller wholesalers, until finally making it to the local 
pharmacy. With

[[Page 9630]]

prescription drugs repeatedly changing hands and the prospect of high 
profits, counterfeiters have the ability and the motive to interject 
these fake drugs into America's prescription drug distribution system.
  My legislation aims to make it more difficult for counterfeiters to 
infiltrate the system. My bill calls for an audit trail of everyone's 
hands the drugs have been in, from manufacturer to pharmacy. It calls 
for the utilization of the best anti-counterfeiting technologies. It 
gives the FDA authority to recall drugs that may have been tampered 
with. It authorizes funds for spotchecking and education. Finally, it 
increases the criminal penalties for counterfeiters, including up to 
life in jail.
  It is my hope that this Congress will address the issue of 
counterfeiting, and I am looking forward to working on a bipartisan 
basis to enact this legislation.

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