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Kennedy Endorses Drug Importation Sen. Edward M. Kennedy (D-Mass.) gave a limited endorsement yesterday to city and state governments that want to buy low-cost prescription drugs from Canada, saying he would support the Boston Tea Party-style rebellions despite warnings about safety risks. Kennedy's shift came at a critical time for leaders from Boston, New Hampshire and Minnesota who say they are pressing ahead with their arguably illegal importation programs. Although each plan differs in its details, the Food and Drug Administration has steadfastly refused to give its blessing to any attempt to import prescription drugs from Canada on a large scale. Yesterday William Hubbard, a senior associate commissioner at the FDA, reiterated the agency position that "anything that sends American citizens to a foreign country to buy an unapproved drug is going to be risky." But the FDA's adamancy has served to embolden the growing number of elected officials across the country who say they are desperate for a way to reduce skyrocketing drug bills and score political points with consumers. Standing beside Boston Mayor Thomas Menino at a Capitol Hill news conference, Kennedy said the city's plan to develop a mail-order Canadian drug program contained sufficient safety protections to win his support. The Boston program will direct 7,000 city employees and retirees to a handful of licensed Canadian pharmacies that meet additional safety requirements that deal with the packaging and shipping of medicine. "Mayor Menino is standing up for the citizens of Boston, and I'm proud to stand with him," Kennedy said. "The people of Boston want action." As Kennedy and Menino touted the Boston plan, Minnesota Gov. Tim Pawlenty (R) dispatched a team of health officials to investigate several Canadian pharmacies interested in partnering with his state. Like Boston, Minnesota intends to work only with licensed Canadian pharmacies. The state will give its "seal of approval" to those drug distributors it deems safe and reliable, and to make the information available to all state residents. "There is a misperception that reimportation from Canada is some risky endeavor in which we give up safety to use a Third World apothecary just to save a dime," Pawlenty said at a recent congressional hearing. "Canada's pharmaceutical regulatory system is strong and effective." New Hampshire's Republican Gov. Craig Benson announced recently that his state will begin buying medicine for prison inmates and Medicaid recipients from Canadian firms. State officials in Illinois, Iowa, Maine and West Virginia have also been studying the possibility of buying medications for their employees or residents from outside the United States. For some, the savings could be millions of dollars. The FDA never made a fuss over senior citizens who, for nearly a decade, have been taking buses to buy medications in Canada, where they can cost as much as 70 percent less than in the United States. But as nonprofit consumer groups, profit-making companies and the city of Springfield, Mass., began importing drugs in larger numbers, the FDA has stepped up its rhetoric and enforcement activity. In harshly worded letters, the agency has warned that city and state governments could be sued if someone received an inferior drug through one of its programs. As prices have climbed, however, even those sympathetic to the FDA's concerns have grown frustrated that the agency has shown little inclination to devise innovative ways to safely import cheaper medicines. Kennedy has long agreed with the FDA and backed legislation that required safety certification of imported drugs by the secretary of health and human services. But aides said he has "become convinced the secretary will never certify" an importation program and so decided to push alternative approaches. Kennedy's frustration was evident yesterday. "This issue is not about the safety of prescription drugs," he said. "The administration is worried about the safety of the profits of the prescription drug industry." Kennedy and Menino argue that the recently passed Medicare prescription drug law gives regulators the authority to create a safe importation program, perhaps by granting waivers to some cities or states or by setting up demonstration projects. But Hubbard said lawyers at the FDA do not agree with that interpretation. Currently there is a "cottage industry" of shady drug importers, Menino said. "Why can't we regulate drug importation?" Anticipating legal battles over interpretation of the Medicare provisions, Kennedy is sponsoring a bill that would explicitly instruct the administration to develop a safe importation program using licensed Canadian pharmacies and approved ports of entry. The bill would require the FDA to monitor those imports and impose user fees to pay for additional FDA inspectors. Kennedy remains reluctant to permit Internet sales from outside the United States, because he worries that those transactions would be harder to track. Copyright
© 2002 Global Action on Aging |
