(Excerpt from the Congressional Record of Congressman John D. Dingell's statement before the House of Representatives on July 24, 2003, as found at Thomas Legislative Information on the Internet [thomas.loc.gov].  Also available is GPO's PDF.)

July 24, 2003       CONGRESSIONAL RECORD--HOUSE      H7597-H7598

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Mr. DINGELL. Mr. Speaker, I yield myself 3 1/2 minutes.

(Mr. DINGELL asked and was given permission to revise and extend his remarks.)

Mr. DINGELL. Mr. Speaker, this is a bad bill. On its face it would appear to be a good bill. It is not. It will allow this country to be flooded with unsafe, counterfeit drugs; drugs that will not do what they should; drugs that are unsafe; drugs that will kill the American people. I tell Members, it is a bad bill, and I ask them to remember the experiences that were reported by my colleague from Louisiana.

This bill would reduce the capacity of the Food and Drug Administration to protect our people from unsafe prescription pharmaceuticals, which will begin to flood the country if and when it is passed.

H.R. 2427 is a prescription for trouble. They open our borders. They provide millions of Americans with access to perhaps drugs which are cheaper, but drugs which are unsafe and which evade the responsibility and the ability of Food and Drug to protect the American people.

Mr. Speaker, do not take my word for that. Listen to what the health care professionals and regulators say.

The American Medical Association says, ``We believe H.R. 2427 would be so dangerous to patient safety that we must oppose it. This legislation would eliminate most of the important restrictions on reimportation of pharmaceuticals in current law and replace them with a system of unverifiable and unsafe provisions.''

The National Medical Association has said, ``This legislation would result in counterfeit, adulterated, and dangerous drugs entering the United States. We do not believe that H.R. 2427 should be enacted at the risk of jeopardizing patient safety.''

The American Osteopathic Association says, ``H.R. 2427, while increasing the possible number of drugs reimported into the United States, does nothing to ensure the safety and efficacy of these drugs. There is no bargain to be found for our patients who purchase drugs that are ineffective or contaminated.''

The Food and Drug Administration says, ``H.R. 2427 would authorize the importation of prescription drugs from foreign sources without adequate assurances that such products are safe and effective. H.R. 2427 creates a wide channel for large volumes of unapproved drugs and other products to enter the United States that are potentially injurious to public health and pose a threat to the security of our Nation's drug supply. The bill would do so by taking unprecedented steps that limit FDA's authority to assure the safety of prescription drug products to be used by American consumers.''

Mr. Speaker, this will enable foreign manufacturers to import into Canada for reimportation into the United States tons of counterfeit foreign drugs, drugs which are ineffective, over-age, unsafe, unregulated and improperly manufactured in ways which will offer threats to the United States, to our citizens and to the people who are looking to you to see to it that their food, drugs and cosmetics are safe.

Mr. Speaker, let us look at it. Foreigners are going to use this device to enter Canada to sell unsafe drugs to the American people. Do not deceive yourself to think that any one of those importers will be bound by any requirements of American law or that they will, in fact, sell those drugs at less price. They will simply sell them at U.S. market prices, and you are going to have on your hands the possibility that you have voted to injure, sicken, hurt or kill the American people by allowing the importation of unsafe drugs.

Recent Counterfeits

COUNTERFEIT LIPITOR

Lipitor, a cholesterol-lowering medicine, is used by 11 million Americans each year to help prevent serious heart disease. Last month, according to FDA, a large quantity of fake Lipitor entered the U.S. market. The product was imported to the U.S. and repackaged here, for sale to distributors and pharmacies. To date, FDA and Lipitor manufacturer Pfizer have recalled 200,000 bottles of this dangerous phony product.

FAKE AND MISLABELED ZERIT

Counterfeit Zerit, a medication to treat HIV infection, was first discovered in 1997. According to the real manufacturer, Bristol-Myers Squibb, this not only was not its authentic product, but the labels incorrectly told consumers they were taking 30 mg, when in fact the capsules inside the bottles allegedly contained 40 mg of the active ingredient. Patients were exposed both to a product of unknown origin and the dangerous possibility of an overdose.

PHONY CLARITHROMYCIN

This antibiotic, called Biaxin, is used to treat infections such as pneumonia, bronchitis, and ear infections--including infections in children. Recently, according to the drug's manufacturer, Abbott, counterfeit Biaxin, containing absolutely no active ingredient, has been found in Russia (where counterfeits make up 15 percent of the prescription drug market). Because the legal system in Russia makes pursuit and punishment of these counterfeiters difficult, these dangerous products remain available in Russia as well as for export to other lucrative markets like the U.S.

COUNTERFEIT NEURONTIN, ACCUPRIL, AND CELEBREX

Counterfeits of these Pfizer products--Neurontin, for seizures in children 3 and older and adults and for treating shingles pain in adults; Accurpril, for high blood pressure; and Celebrex, for treating debilitating arthritis pain--have recently been found in California, at a company called NuCare Pharmaceuticals. Laboratory analysis confirmed no active ingredient in any of the tablets, which actually were vitamins. Neither the origin of the bottles nor the disposition of the original medications is known.

FAKE ALLEGRA

Fexofenadine, an important active ingredient in products to treat allergies, is sold under the name Allegra in the U.S. Recently, security personnel of the product manufacturer, Aventis, ordered Allegra from an internet site purported to be based in the UK. The product shipped was one called Telfast, a fexofenadine product sold in other countries, but not approved by the U.S. FDA. Furthermore, a stick-on label indicated an expiration date of 1/03; the product actually had expired in 1/02. Finally, although the web site appeared to be promising products from a ``safe'' country in the UK, this product came not from the UK but from Vanuatu, an island off the coast of New Zealand well known for businesses trafficking in illegitimate prescription drugs destined for the U.S.

FAKE LOSEC

Losec (omeprazole), a treatment for ulcers and other gastric conditions, is sold in the U.S. as Prilosec. A generic version of Prilosec is also on the market in the U.S. Counterfeit Prilosec, according to its manufacturer AstraZeneca, was manufactured in an underground facility and distributed through an affiliated wholesaler. The counterfeiter boasted that the copies were sufficiently clever to avoid detection by the government and, in fact, only AstraZeneca had the technical information necessary to determine this product was a fake.

COUNTERFEIT MONOPRIL

Fakes of this high-blood-pressure medication were discovered earlier this year by the LA County Sheriff's Office. The counterfeit operation was uncovered after a local printing company contacted the sheriff to report a suspicious order for thousands of drug product labels. The product, vitamins substituted for the real pills, bottle caps, and seals were all counterfeit. Arrested individuals were owners of prescription drug diversion businesses in Canada, Europe, and Asia. Many other drugs found in the LA raid were

[Page: H7598] GPO's PDF

expired or fake, then repackaged, relabeled, and sold to American doctors and pharmacies.

COUNTERFEITS FROM INDIA

According to FDA, an American patient ordered product from an internet site promising ``Canadian drugs manufactured in the U.S.'' The drug he appears to have needed was a seizure medication called gabapentin. What he received was a knock-off from India, labeled ``Gabantin.'' What IS ``gabantin?'' Only the counterfeiter in India, and the so-called ``Canadian'' on-line pharmacy knows. The patient was the unwitting dupe.

COUNTERFEIT PROCRIT

Epoetin alpha, marketed as Procrit, treats anemia in patients with chronic kidney disease, HIV, and cancer. The first discovery of counterfeit Procrit was made in 2002; subsequent discoveries followed. The counterfeit, of unknown origin, has been found at two large wholesalers and a number of retail outlets. The counterfeit, some with 20 times less active ingredient than the real drug and some with no active ingredient but bacteria-contaminated water, appeared identical with the authentic product. Sophisticated anti-counterfeiting technology used on this product failed to challenge the ingenuity of the counterfeiters, who quickly learned to mimic it.

FAKE CRIXIVAN, PEPCIDINE, ZOROXIN, AND ZOCOR

According to Merck, the manufacturer of these products, substantial quantities of counterfeits were found in a police raid on a home in Bogota, Columbia. In addition to these products, the home possessed many other counterfeits. English language labeling suggested the final destination for many; unwary U.S. patients.

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