[Congressional Record (Bound Edition), Volume 149 (2003), Part 15]
[Extensions of Remarks]
[Pages 21052-21053]
[From the U.S. Government Publishing Office, www.gpo.gov]




                               H.R. 2473

                                 ______
                                 

                            HON. MIKE ROGERS

                              of michigan

                    in the house of representatives

                      Wednesday, September 3, 2003

  Mr. ROGERS of Michigan. Mr. Speaker, I intend to vote ``no'' on H.R. 
2473 because it carelessly threatens the safety of American consumers. 
In a recent hearing before the House Oversight and Investigations 
Subcommittee, of which I am a member, we heard from numerous 
individuals including William Hubbard, the Associate Commissioner for 
Policy and Planning with the Food and Drug Administration. Commissioner 
Hubbard testified that since late 1996, the FDA has initiated 73 
counterfeit drug cases that have netted in 44 arrests and 27 
convictions. He further testified that they have seen an increase in 
drug counterfeiting activity targeting high volume, high cost drugs 
primarily those used for treating cancer and AIDS patients.
  One case, cited by Florida's Assistant Statewide Prosecutor, revealed 
a 2001 investigation that discovered South Florida criminals had 
counterfeited Procrit, a drug used to boost the immune systems of 
cancer and HIV/AIDS patients. The criminals re-labeled approximately 
110,000 bottles of low strength Epogen to make the bottles appear to 
contain high strength Procrit, a drug 20 times the strength of the 
Epogen in the bottles. The criminals resold the relabeled drugs into 
the wholesale market with forged pedigree papers, passing the drugs 
through four states. Investigators located 800 boxes of the counterfeit 
Procrit at a large Texas wholesaler, which had unknowingly purchased 
the counterfeit Procrit. In addition, investigators found some of the 
product in Kentucky. In all, investigators recovered less than 10% of 
the counterfeit Procrit.
  In conclusion, ``the imported drugs arriving through the mail, 
through private express couriers, or by passengers arriving at ports of 
entry are often unapproved new drugs that may not be subject to any 
reliable regulatory oversight. FDA cannot assure the safety of drugs 
purchased from such sources,'' stated Commissioner Hubbard. It is for 
these reasons that I can not support such legislation that we have no 
way of knowing of its content or origin. I am firmly committed to 
continuing efforts to reduce the out-of-pocket costs for 
pharmaceuticals for all Americans but H.R. 2473 and drug reimportation 
without any safety measures is the wrong approach.

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