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Senator David Vitter wants the FDA to stop looking for dangerous or counterfeit imported drugs


Robert Goldberg, Ph.D.
Medical Progress Today
September 21, 2005

At a time when the FDA is under pressure to increase the safety of medicines developed and prescribed here at home, legislators such as Senator David Vitter of Louisiana want to deprive the agency of resources to increase vigilance against unapproved or counterfeit medicines from abroad.

George Santayana observed that “fanaticism consists in redoubling your efforts when you have forgotten your aim.” What else can explain the feverish attempts by Vitter and other supporters of drug importation to actually defund the Food and Drug Administration’s inspection and investigation of drug shipments to make sure they are safe and effective? At a time when the percentage of counterfeit drugs in Canada and Europe is at an all-time high, the idea that members of Congress would prevent the FDA from tracking and tracing the origin of medicines is incredible.

If Vitter and his fellow travelers really care about drug safety, why are they hell-bent on increasing the commercial quantities of medicines, from price-controlled countries, by whatever means possible?

Let us go back to the beginning of this issue. Importation proponents, like Congressman Gil Gutknecht, say that shipping drugs in from other countries would save us at least – at least - $630 billion over the next decade. That would mean nearly 40 percent savings on what America spends on medicines each year. Europe, however, saves less than one percent through its drug-importation system (called parallel trade), even though 20 percent of its drugs are imported from low price controlled nations. Mark-ups from middlemen, and government regulations, eat up the rest of the savings.

As a recent Health and Human Services drug-importation task-force report made clear, there are simply not enough price-controlled drugs for the import plan to work – not even in the one country from which it might be safe to import them. For the second time in a year, Canada asserted that it will not honor any bulk orders of any medicines to protect its limited stocks. Importation proponents have no real plan to come up with the rest of the medicines, except by barring the FDA from searching for fake drugs. They ignore the fact that even Canada, which is a net importer of medicines, receives shipments of drugs from countries such as Iran, Romania, Pakistan and India—which are major sources of counterfeit medicines.

If Vitter is so concerned with safety, moreover, why would he force the FDA to allow the importation of drugs not approved by the FDA into the United States? Vitter and others would require the forced importation of products that are, by definition, completely different than those available in America. Dosing and formulations of drugs in Europe vary widely; most serious side effects are a result of taking the wrong dose or a sub-optimal route of administration. Hence, for all their professed concern about safety in the post-Vioxx era, the importation lobby’s cavalier approach to drug safety will jeopardize American patients.

The drug-importation advocates have invoked “free trade,” but their claims have not provoked careful scrutiny. If importation-advocates really want price-controlled medicines so badly, they should propose them here, instead of forcing the importation of drugs that will inevitably be produced in Iran, Romania, Brazil and India, but shipped from France or Canada or Germany. They should, in short, come clean on the main policy question: Will we impose price controls, and outsource our flourishing biomedical industries to the Far East? Or will the U.S. will remain as the world’s best hope for fighting disease and biomedical innovation, enriching life for generations to come?


Robert Goldberg, Ph.D. is director of the Center for Medical Progress at the Manhattan Institute for Policy Research.

 
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