On August 2, more than 610,000 doses of flu vaccine purchased by Illinois, New Mexico, Cleveland, and New York City expired without being used, and without even entering the country. It was a costly and embarrassing mistake by public officials apparently hoping to pressure Republicans and the Food and Drug Administration (FDA) to approve importing prescription drugs from foreign countries.
The drugs were ordered from European suppliers last fall, even though the transaction would have violated federal laws banning their importation. Illinois found it could not discount the flu shots for resale in the Southern Hemisphere. The state then tried to dump the expiring drugs in South Africa through donation to the Nelson Mandela Foundation. South Africa’s equivalent of our FDA scuttled that effort.
Now, Illinois Gov. Rod Blagojevich (D) and his colleagues are blaming Republicans and the Bush administration for refusing to approve the purchase.
They ought to blame themselves.
Had there been a genuine public health crisis that required importing the vaccine from abroad, the FDA probably would have granted a waiver of its rules. With plenty of local vaccine available and a milder than expected flu season, the FDA saw no need to lift its ban on importing drugs, which has been in place since 1988.
Blagojevich, who ordered for Illinois 256,000 flu shots at a cost of $2.5 million, would have us believe the Department of Health and Human Services, Food and Drug Administration, and Centers for Disease Control are engaged in some kind of conspiracy against the public interest by denying foreign-made vaccines to senior citizens. But it is much more likely that these government agencies, which have been guided by Democratic as well as Republican administrations during the past 16 years, have good reasons to enforce the ban on imported drugs.
A year ago, William K. Hubbard, then associate commissioner for policy and planning at the FDA, told the Senate Committee on the Judiciary, “Many drugs obtained from foreign sources that either purport to be or appear to be the same as U.S.-approved prescription drugs are, in fact, of unknown quality. Consumers are exposed to a number of potential risks when they purchase drugs from foreign sources or from sources that are not operated by pharmacies properly licensed under state pharmacy laws. These outlets may dispense expired, subpotent, contaminated or counterfeit product, the wrong or a contraindicated product, an incorrect dose, or medication unaccompanied by adequate directions for use.”
Hubbard went on to say, “The labeling of the drug may not be in English and therefore important information regarding dosage and side effects may not be available to the consumer. The drugs may not have been packaged and stored under appropriate conditions to prevent against degradation, and there is no assurance that these products were manufactured under current good manufacturing practice (CGMP) standards. When consumers take such medications, they face risks of dangerous drug interactions and/or of suffering adverse events, some of which can be life threatening.”
It is a mystery why liberals, who often feign concern over the tiny threats to health posed by exposure to a few parts-per-trillion of a chemical, nevertheless support exposing senior citizens to much greater risks by allowing foreign drugs into the country. A mystery, that is, until one realizes it is entirely a ploy to demonize conservative Republicans and large drug companies.
This whole episode serves only to illustrate why states have no business acting as brokers and wholesalers of drugs from foreign countries.
Joseph L. Bast ([email protected]) is president of The Heartland Institute, a 21-year-old nonprofit organization based in Chicago.