- The Washington Times - Sunday, March 7, 2004

If you are Sens. John McCain and Byron Dorgan, your browbeating of Food and Drug Administration Commissioner Mark McClellan must qualify as a low watermark of your careers in the Senate. The pair are furious that Dr. McClellan has warned that importing medicines from Canada and leading producers of counterfeit drugs, such as South Africa, is unsafe. So they have cut a profile in petulance, threatening to hold up his nomination to oversee Medicare until he either changes his mind or shuts up.

Dr. McClellan is an excellent FDA commissioner who has done much to lower drug prices in his short tenure. He has increased funding and reduced red tape for generic drug approvals and is paving the way for shifting whole classes of medicines from prescription to over-the-counter status. And he is seeking to cut the cost and time of drug development sharply, which would translate into lower than expected launch prices for the newest drugs. At the same time, Dr. McClellan has made the issue of Canadian and European free riding on American drug development through their price controls a global trading issue.

Dr. McClellan is also considered bright, fair and hardworking. He is a reformer who will not only implement the new Medicare bill, but will seek to improve the qualityofMedicare by promoting the use of the best technology regardless of whose political interests are unsettled.

But he has determined that the FDA cannot vouch for the safety of imported drugs or determine that importing drugs can save money. And because Dr. McClellan won’t give Messrs. McCain and Dorgan (the latter has fought against the importation of Canadian cattle because of safety concerns) the answer they want, the pair are set to drive this highly qualified individual out of public service. It would be one thing if Dr. McClellan was acting out of ignorance, pique or political ambition. But the FDA’s refusal to allow drug importation is based on a growing body of evidence that the quality of drugs is often suspect and the distribution system here and abroad is open to counterfeiters and medical errors.

Messrs. McCain and Dorgan would have us believe that the FDA should allow anyone to import drugs from any source at any time, and that it would save $635 billion each year under their bill. That’s astounding, since Americans only spend $170 billion on drugs each year. Politicians of all stripes were pushing the claim that importation of medicines from other countries or their purchase via the Internet without a strict chain of custody and legal liability, upgraded enforcement and the creation of a sophisticated tracking and detection system could be as safe as importing beef from Canada until the FDA got into the act.

Mr. McCain mocked Dr. McClellan’s concern about medicines coming from “that ThirdWorld,poverty stricken, unregulated nation from the North.” The senator doesn’t know how right he is. Canada has been steadily increasing the quantities of medicines it brings in uninspected from countries such as India, Pakistan and Iran. Those countries are major suppliers of bogus drugs in Afghanistan and Iraq. In fact, if Mr. McCain had bothered to read any of the reports about drugs interdicted by the FDA, he would know that most of them are not from Canada. Also, many drugs obtained through at least one of the pharmacies that Minnesota plans to purchase drugs from were apparently not even of Canadian origin.

As a result of Dr. McClellan’s efforts, even states toying with the idea of violating federal law in this regard — including Illinois — now propose to limit the types of drugs to less than a hundred to buy in manufacturer’s packaging and ship through a centralized pharmacy to reinspect and test all products. Indeed, such programs save little money. Covering the costs of shipping and insurance and establishing a chain of custody and a centralized pharmacy would virtually wipe out any savings.

Finally, Dr. McClellan notes that with the introduction of the Medicare drug discount card, drugs from Canada aren’t always cheaper. In fact, a survey of the 50 most prescribed medicines in American found that 55 percent are more expensive or about the same price in Canada once American discounts and Canadian mail order shipping costs are taken into account.

All this infuriates Messrs. McCain and Dorgan, because it exposes importation as a cheap political trick. They are holding Dr. McClellan hostage — not because they disagree with him but because they want to shut him up.

Robert Goldberg is director of the Manhattan Institute’s Center for Medical Progress.

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