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The FDA Deceives Congress
There is no inherent reason why prescription drugs should cost so much in the U.S. The identical medications can be purchased in Europe and Canada at far lower prices. The trouble is that the FDA has fabricated sworn testimony to mislead Congress into believing that drugs from other countries are counterfeit, contaminated, or dangerous. Life Extension has shown that the FDA’s assertions are baseless, false, and misleading (see “The FDA Versus The American Consumer,” Life Extension magazine-October 2002).
On June 7, 2001, the FDA told Congress that it wants to halt almost all small shipments of foreign drugs mailed to consumers in the U.S. The only exemption would be for compassionate use, so that seriously ill patients who have exhausted all approved treatments could order drugs from overseas. The FDA told Congress:
“We need to be able to make a blanket assessment that these things are not safe for American consumers and should be turned back.”
In response to the FDA’s assertions, Life Extension sent Freedom of Information Act requests in June 2001 asking the FDA to substantiate its sworn testimony before Congress that drugs imported from other countries are dangerous.
Even though the FDA is legally mandated to respond to Freedom of Information Act requests, it has ignored our repeated written requests and phone calls to substantiate its sworn testimony about the supposed dangers of imported medications.
More than two years have now passed since the FDA told Congress that medications imported from other countries are counterfeit, contaminated, and dangerous. As more Americans learn they can obtain identical drugs from Canada and other countries at lower prices, the flow of imported drugs has grown enormously. Yet the FDA has yet to produce a single report of an adverse reaction from an imported prescription drug, despite being highly motivated to find just one “victim” to parade before Congress.
That does not mean there have not been any victims of prescription drugs ordered from other countries. The facts are that FDA-approved prescription drugs kill over 100,000 Americans every year. Since these same FDA-approved drugs are being imported from other countries in record amounts, undoubtedly some Americans have suffered adverse effects, just as they would have had they bought the same drug at their local pharmacy.
The undeniable fact, however, is that prescription drugs used by Canadians and Europeans are identical to those sold in American pharmacies. In fact, when regulators alleged that a generic European Hydergine product was “adulterated,” Life Extension had the product assayed and proved that this European Hydergine was identical to the name brand (Sandoz) sold in the United States.
The FDA’s assertion that prescription drugs imported from other countries are dangerous is a hoax that never had a credible basis. It is a scare tactic to protect the pharmaceutical industry’s stranglehold over the American consumer.
Counterfeit Drugs Sold in American Pharmacies
Counterfeiters tend to copy expensive items. You don’t find many fake $5 bills, but $100 bills have long been a favorite of those involved in criminal currency counterfeiting.
Prescription drugs sold in other countries don’t cost a lot, so the incentive to counterfeit them is not great. These same drugs sold in the United States, however, are so expensive that counterfeit drugs are increasingly showing up in American pharmacies.
Procrit® is a drug used to treat anemia. Cancer patients often use Procrit® to guard against chemotherapy-induced hypoxia (a low oxygen environment that enables cancer cells to thrive). The CBS News program 60 Minutes reported on an epidemic of Procrit® counterfeiting that is occurring as illicit wholesalers sell bogus Procrit® to American pharmacies. The counterfeit Procrit® has little or no active ingredient and some batches are contaminated with bacteria that have made patients very ill. The startling part of this story was when CBS News asked the FDA about Procrit® counterfeiting, the FDA responded that this was a problem for state pharmacy boards to address and was not in the FDA’s jurisdiction.
The FDA’s statement that Procrit® counterfeiting is not its problem is grossly inconsistent and hypocritical, considering its vigorous opposition to American consumers importing lower-cost medications from other countries. Cancer patients who buy Procrit® from Canada often do so because they cannot afford to pay inflated American prices for this life-saving drug. The FDA seeks to deny these desperate people access to lower- cost Procrit® under the assumption that it might be dangerous, while virtually ignoring egregious counterfeiting going on in the American marketplace.
Growing reports of Procrit® counterfeiting have since motivated the FDA to take limited action. The FDA later stated that fake Procrit® poses a serious danger to patients and posted a warning on its website (www.fda.gov). To help identify the dangerous counterfeit, the maker of Procrit® has posted pictures of the real and fake version on its website, www.procrit.com.
When American pharmacies recently became flooded with 130,000 bottles of counterfeit Lipitor®, the FDA did take more aggressive action. Lipitor® is the most popular cholesterol lowering “statin” drug. Since the active ingredient for 90 tablets (10 mg) of Lipitor® costs only $2.18, which American consumers then pay over $170 for, it is easy to see the economic motivation for counterfeiting this drug.
The Pharmaceutical Market Access Act of 2003 requires all prescription drugs produced at home and abroad to use counterfeit-resistant packaging, similar to the technology used by the U.S. Department of the Treasury. The Pharmaceutical Market Access Act contains language written by the legal team at the FDA that requires wholesalers to test each pharmaceutical shipment, unless the packaging uses counterfeit-resistant technology. The FDA’s strict language was written to provide for the safety of imported pharmaceuticals from anywhere in the world.
What this means is that if this drug import bill is passed, lower- cost medications imported from other countries would be subjected to better scrutiny than those produced in the United States. Drug company (and Jerry Falwell) propaganda that imported drugs are dangerous has no basis in fact. The unfortunate reality is that expensive prescription drugs sold in the United States are being counterfeited because the profit opportunity is much greater than in other countries.
If the Pharmaceutical Market Access Act of 2003 is not passed, however, we fear that there may be more counterfeiting as increasing numbers of Americans are economically forced to turn to offshore pharmacies in order to afford medications they need to stay alive. There are so many elderly Americans importing drugs from other countries, that the FDA has admitted it cannot possibly intercept them all. So if this bill is not passed, personal use drug importation will continue with no regulatory protections in place.
Some members of Congress are alleging that some counterfeiting of Canadian drugs is already occurring, but as we just discussed, this problem exists for drugs sold in American pharmacies as well. Failure to pass this bill will result in more counterfeiting, as Americans increasingly turn to lower-cost sources (both foreign and domestic) for their medications.