Federal Task Force Holds Third Meeting on Prescription Drug Reimportation
The federal Task Force on Drug Importation on Wednesday held a third meeting to allow the public to comment on the reimportation of prescription drugs from other nations, Reuters/Philadelphia Inquirer reports (Richwine, Reuters/Philadelphia Inquirer, 4/15). The 13-member task force has held a series of meetings as part of a study -- mandated by the new Medicare law -- on the safety of reimportation and the effect of the practice on prescription drug development. Task force members, who 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 the Unites States could establish a safe reimportation system. In the second meeting, pharmaceutical company executives testified that reimportation would reduce the incentive for companies to invest in new medications and allow more counterfeit treatments to enter the United States. The task force must report the results of the study to Congress by Dec. 1, although Thompson has said that he hopes to complete the study by mid-summer (California Healthline, 4/14).
About three dozen witnesses testified at the meeting on Wednesday. Wisconsin Gov. Jim Doyle (D), who established a state prescription drug Web site that links residents to Canadian online pharmacies, testified, "People are going to Canada whether we like it or not. They are going in bigger and bigger numbers. The simple dollars demand it" (Sherman, AP/Las Vegas Sun, 4/14). Doyle added, "It is time for the FDA to stop doing the bidding of the drug lobby and start helping" U.S. consumers. Officials for the state of Illinois said that they had to file a "four-inch thick citizens petition to get the FDA to consider a request" to establish a pilot reimportation program, the Washington Post reports (Connolly, Washington Post, 4/15). Tom Curb -- a pharmacist who has helped Montgomery, Ala., city employees reimport prescription drugs from Canada -- testified that FDA has a responsibility to ensure the safety of reimported medications to prevent a "grave and imminent danger to American consumers" (Reuters/Philadelphia Inquirer, 4/15).
Two patient advocacy groups from Canada -- the Consumer Advocare Network and the Canadian Treatment Action Council -- testified that reimportation has caused problems for Canadian patients and that legalization of the practice in the United States "would exacerbate the problem," CongressDaily reports. Reimportation "cannot be a permanent solution for the access problems that Americans are having," Derhane Wong-Rieger, chair of CAN, said, adding, "When you have a country that is one-tenth the size of the U.S., ... our supply is clearly not going to be sufficient." Louise Binder, chair of CTAC, said, "FDA should stand firm on its opposition to cross-border Internet pharmacies and find a permanent solution." Officials for both groups said that for the first time, pharmaceutical companies in 2003 raised some prescription drug prices to the maximum allowed under Canadian law because of reimportation. In addition, they said that sales to U.S. consumers by Canadian online pharmacies have led to shortages of treatments for diabetes and cancer in Canada. The groups also said that legalization of reimportation would "increase pressure on Canada to deregulate its drug-pricing system," CongressDaily reports (Heil, CongressDaily, 4/14).
Rick Roberts, who received counterfeit AIDS medication from a U.S. pharmacy, testified that the legalization of reimportation would allow more counterfeit medications to enter the United States because the "longer the distribution chain, the more doors that are open to let these bad guys do what they do, which is to make money off of sick people" (Reuters/Philadelphia Inquirer, 4/15). Former New York City Police Commissioner Bernard Kerik, whose consulting company was hired by the Pharmaceutical Research and Manufacturers of America to investigate reimported prescription drugs, said that the legalization of reimportation could "invite terrorists to launch a biological attack under the guise of a legal purchase," the Post reports. Former Justice Department attorney Jeffrey Axelrad testified that groups or municipalities that help facilitate reimportation could face liability risks. James Green, an executive with King Pharmaceuticals, said that his staff ordered reimported prescription drugs from Canada, Fiji and Pakistan and found a "dangerous bait-and-switch scam" in which consumers who ordered the thyroid medicine Levoxyl, manufactured by King, received Synthroid. FDA has approved Synthroid, manufactured by Abbott Laboratories, to treat thyroid insufficiency, but the medication is not "therapeutically equivalent" to Levoxyl, Green said (Washington Post, 4/15). Kurt Hilzinger of the Healthcare Distribution Management Association, said that the new safety and authenticity standards for reimported prescription drugs could "erase the price advantage" of such medications, Gannett/Detroit News reports. Hilzinger added that U.S. prescription drug wholesalers have concerns about the management of recalls, nation-of-origin labels and package requirements for reimported medications (Tumulty, Gannett/Detroit News, 4/15). Surgeon General Richard Carmona, chair of the task force, said that reimportation is "an extraordinarily complex topic that challenges the best minds in the field" (Reuters/Philadelphia Inquirer, 4/15). He added, "This task force is first and foremost about the facts and the science. And we will go as far as the facts and the science lead us" (Gannett/Detroit News, 4/15).
PBS' "Nightly Business Report" on Wednesday reported on the task force meeting. The segment includes comments from Doyle; Kuhlik; and Mike O'Grady, HHS assistant secretary for planning and evaluation (Gersh, "Nightly Business Report," PBS, 4/14). The complete transcript is available online. In addition, MPR's "Marketplace" on Wednesday reported on Canadian online pharmacies that have begun to seek supplies from Europe. The segment includes comments from Daren Jorgenson, CEO of Canadameds.com; David Robertson, president of Crossborderpharmacy.com; and Jeff Trewhitt, a spokesperson for PhRMA (Palmer, "Marketplace," MPR, 4/14). The complete segment is available online in RealPlayer.This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.