House Approved Measure Allowing Individuals to Reimport Rx Drugs
The House yesterday approved a measure to allow individuals to purchase FDA-approved prescription drugs from certain foreign countries, but rejected a proposal to allow drug distributors and marketers to import drugs for sale to U.S. consumers, the Los Angeles Times reports (Rosenblatt/Chen, Los Angeles Times, 7/12). The votes, both offered as amendments to the fiscal year 2002 agricultural appropriations bill, came one day after HHS Secretary Tommy Thompson said that he would not "certify" a law passed last year allowing wholesalers or pharmacies to reimport drugs because the FDA cannot guarantee their safety. By a vote of 324-101, the House passed an amendment, sponsored by Rep. Gil Gutknecht (R-Minn.), that allows consumers either to purchase drugs in the other seven G-8 industrialized nations or to mail-order them from these countries (Gordon, Minneapolis Star-Tribune, 7/12). The amendment would, for example, allow U.S. consumers who currently travel to Canada to purchase lower-cost drugs to "forgo travel and instead legally use the Internet or a fax machine," the Times reports (Los Angeles Times, 7/12). Commenting on the disparities between drug prices in the United States and in other countries, Gutknecht said, "My amendment ensures that law-abiding citizens will be able to import legal, FDA-approved prescription drugs made in FDA-approved facilities" (Pear, New York Times, 7/12). Current law does not "specify" whether it is legal for individuals to import drugs, but the FDA "often sends letters" to consumers who import drugs, "warning [that] they might be in violation of federal law," the Los Angeles Times reports (Los Angeles Times, 7/12). Later yesterday, the House approved the entire appropriations bill by a vote of 414-16 (Carroll/Lueck, Wall Street Journal, 7/12).
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The FDA, saying it cannot "guarantee whether imported medications are safe or effective," opposed both amendments considered yesterday, as did the pharmaceutical industry (Brasher, AP/Philadelphia Inquirer, 7/12). Last month, citing fears about counterfeit drugs, FDA officials recommended that almost all small foreign prescription drug shipments found by U.S. Customs Service agents at mail-inspection sites be returned to their sender. The House yesterday agreed in part with these safety concerns, rejecting by a vote of 267 to 159 an amendment by Rep. Bernard Sanders (I-Vt.) that would have prevented the FDA from enforcing a 13-year-old ban on reimportation of U.S.-made drugs by wholesalers and pharmacies (Minneapolis Star-Tribune, 7/12). Many members of Congress said that large-scale reimportation would jeopardize drug safety. Rep. David Obey (D-Wis.) said, "I agree we need to control the cost of prescription drugs to seniors. But we should not run the risk of allowing large numbers of adulterated drugs into this country" (New York Times, 7/12). The agricultural appropriations bill now moves to the Senate, where it faces an "uncertain fate" and "tough opposition from the Bush administration" and the pharmaceutical industry, the Los Angeles Times reports. Alan Holmer, president of the Pharmaceutical Research and Manufacturers of America, said his organization would "continue to oppose" the Gutknecht amendment, which "would open up the possibility for individuals to bring into the country medicines that may not be as safe or effective as they appear," he said (Los Angeles Times, 7/12).