Drug Companies Tell Task Force That Reimportation of Prescription Drugs Is Unsafe

Reimporting prescription drugs from other nations would be "neither safe nor cost-effective," pharmaceutical companies and distributors said on Monday at the second meeting of the Task Force on Drug Importation, the Los Angeles Times reports (Kemper, Los Angeles Times, 4/6). The 13-member task force is holding the meetings as part of a study mandated by the new Medicare law on the safety of reimportation and its effect on drug development (Groppe, Gannett/Indianapolis Star, 4/6). The task force, members of which were appointed by HHS Secretary Tommy Thompson, can consult with other federal officials and will hold a total of six "listening sessions" with consumer advocates, health care purchasers, providers, health care industry representatives, international stakeholders and the public. In the first meeting, consumer advocates testified that a safe reimportation system could be established (California Healthline, 3/22). The results of the study must be reported to Congress by Dec.1, although Thompson wants the task force to finish by mid-summer (Los Angeles Times, 4/6).

During Monday's three-hour session, John Dempsey of Ortho Biotech said that reimportation "is neither a panacea nor a long-term solution to our country's need for meaningful and affordable prescription drug coverage within health insurance" (Baldor, AP/Minneapolis Star Tribune, 4/6). Drug company executives said that allowing reimportation would "reduce incentives to invest in new treatments," Bloomberg/Philadelphia Inquirer reports. One meeting participant said that drug companies lose as much as 40% of their profit on each prescription reimported from Canada (Dodge, Bloomberg/Philadelphia Inquirer, 4/6). Gordon Johnston, vice president of the Generic Pharmaceutical Association, said that allowing reimportation would "hurt the generic drug industry and erode incentives for providing the lower cost generics," the AP/Star Tribune reports (AP/Minneapolis Star Tribune, 4/6).

Most of the testimony centered on prescription drug counterfeiting, which drug company executives said is a growing problem involving organized crime and some terrorist groups, the Times reports (Los Angeles Times, 4/6). Dillard Howell, director of global product protection for Eli Lilly, said, "We have significant concerns regarding counterfeit syndicates and the flow of product into the United States from Canada, the Internet and other illegal and unsafe distribution channels" (Bloomberg/Philadelphia Inquirer, 4/6). Howell said that many counterfeit drugs come "with packaging that is often indistinguishable from our own, even by experts," adding, "Imagine the impact these highly evolved counterfeiting rings could have in a world where drug importation was legalized" (Gannett/Indianapolis Star, 4/6). S. Lawrence Kocot, senior vice president and general counsel of the National Association of Chain Drug Stores, said that U.S. residents who reimport drugs "assume an incredible risk." Dempsey said that while technologies are being developed to combat counterfeiting, widespread use of such technologies is "as least five years away, maybe 10" (Los Angeles Times, 4/6). Pamela Williamson, vice president at Serono Laboratories, said, "Any perceived or potential cost savings for U.S. consumers achieved through drug importation would be far outweighed by the potential costs to patient safety, product integrity and confidence in the U.S. drug distribution system." She added that to legalize reimportation, FDA would have to establish an "extensive and costly systems to inspect drugs, track shipments and monitor labeling and recalls," the AP/Star Tribune reports (AP/Minneapolis Star Tribune, 4/6). Task force member Mike O'Grady, HHS assistant secretary for planning and evaluation, told the drug industry officials that they "all made a compelling case about the problems of counterfeiting" (Gannett/Indianapolis Star, 4/6). O'Grady added that he is "not so sure consumers are really aware of ... the (counterfeiting) horror stories," adding, "This seems a fairly important topic to add to your communication plans." Surgeon General Richard Carmona, task force chair, ended the meeting by asking if it is "reasonable to think there could ever be a cost-effective importation system where we could guarantee safety to the American public." With other drug industry officials "nodding their heads in agreement," Dempsey said, "I don't know how we could do it," the Times reports (Los Angeles Times, 4/6).

New Hampshire has launched a prescription drug Web site that links state residents to a Canadian Internet pharmacy, Gov. Craig Benson (R) announced Monday, the Boston Globe reports. The new Web site is linked to the governor's home page and directs users to the Internet pharmacy CanadaDrugs.com. In addition, the Web site includes links to a report by two state pharmacists on the safety of CanadaDrugs.com and a report on the laboratory analysis of the differences between drugs reimported from the Canadian pharmacy and drugs bought from local pharmacies (Rowland, Boston Globe, 4/6). "I will not stand by and watch our seniors overpay for lifesaving medication," Benson said, adding, "The pharmaceutical industry has balanced their books on the backs of seniors for too long" (Love, AP/ St. Petersburg Times, 4/5). FDA Associate Commissioner William Hubbard said that Benson's Web site, like similar Web sites in Minnesota and Wisconsin, could allow potentially harmful drugs to reach New Hampshire residents, the Globe repots. Hubbard said that Web sites like Benson's "are illegal activities" and that FDA might have to "ask a federal judge to referee this situation at this point" (Boston Globe, 4/6). David Minnis, a spokesperson for the New Hampshire Pharmacists Association, said, "You don't try and circumvent health and safety by price controls," adding that Benson is "in effect saying that we, the state of New Hampshire, sanction this Web site as safe. This is not a healthy Web site" (AP/ St. Petersburg Times, 4/5).