REAL RE-IMPORTS

The Food and Drug Administration is right to be concerned about the sharp rise in the number of counterfeit drugs being sold in the United States, but the federal government should not confuse the increase in these drugs with the reimportation of lower cost prescriptions.

A new interim FDA report cite the rise in counterfeit drugs from about five reported cases a year in the late 1990s, to more than 20 today. Counterfeit drugs may contain nothing of value or have far lower dosages or be long past their effectiveness date. They are most likely harmful not in what they do, but in what they do not – deliver needed medication to the person taking them. Secretary of Health Tommy Thompson has been trying to link drug reimportation and counterfeit drugs for a couple of years. In 2001, he said, “Moving from the current ‘closed’ distribution system with relatively few importers to an ‘open-border’ distribution system would significantly increase the risk that counterfeit, misbranded, and adulterated drugs would show up on U.S. drug store shelves and in American homes.”

But at a recent news conference FDA commissioner, Dr. Mark McClellan, emphasized that counterfeiting and reimportation were separate issues, according to news reports. He added that counterfeit drugs could be made within the United States.

Nevertheless, several members of Congress recently wrote to Dr. McClellan to protest his agency’s “blitz exams” of re-imported drugs, in which the members claim the agency did no testing of the drugs but declared them unsafe anyway. Rep. Bernard Sanders of Vermont wrote to the commissioner Oct. 6, “At exactly the time the pharmaceutical industry is spending millions to defeat the prescription drug market legislation overwhelmingly passed by the House of Representatives in July, your agency has suddenly become active in highlighting the perils of pharmaceutical products entering the U.S. market from abroad.”

Part of the problem of counterfeit drugs can be found in which drugs criminals choose to fake. The counterfeit market barely bothers with low-cost drugs; it goes for the ones with the highest prices. And given that 30 percent of seniors cannot afford to purchase the medicine their doctors prescribe, say the members of Congress, it is not surprising that unscrupulous people have seized on an opportunity via the Internet. Lowering the cost of drugs – including through the legitimate and safe pharmacies outside the United States – reduces, though hardly cures, both these problems.

Consumers worried about counterfeit drugs can either stay with their local pharmacy or be sure to look for the seal saying “Verified Internet Pharmacy Practice Sites,” which is issued by the National Association of Boards of Pharmacy. Almost all prescription drugs taken in the United States are safe, a few additional steps can increase that number without ending consumers’ access to less expensive drugs from outside the country.