H.R. 2473
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…
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.