Task Force To Hold Third Hearing on Prescription Drug Reimportation; Focus on HIV/AIDS Drug Norvir

The federal Task Force on Drug Importation will hold its third meeting on Wednesday, focusing on the HIV/AIDS drug Norvir, the New York Times reports (Harris, New York Times, 4/14). Wisconsin Gov. Jim Doyle (D) will also testify before the task force about reimportation and his state's Web site that links residents to Canadian Internet pharmacies (Ross, AP/St. Paul Pioneer Press, 4/14). 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. The task force, whose members 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. In the second meeting, drug company executives testified that allowing reimportation would lower companies' incentive to invest in new medications and allow more prescription drug counterfeiting, which the executives said is a growing problem. The results of the study must be reported to Congress by Dec. 1, although Thompson has said he wants the task force to finish by mid-summer (California Healthline, 4/7).

According to the Times, Norvir has become a "touchstone" for the debate over reimportation, and many consumer advocates and members of HIV/AIDS groups will testify in favor of the practice at the meeting. In January, Abbott Laboratories increased to about $7,800 per year from $1,500 per year the price of Norvir, a protease inhibitor that is part of many HIV/AIDS treatment regimens. A year's supply of Norvir costs about $700 in Canada, the Times reports. Abbott officials said that they had to raise the price of Norvir to fund research into other HIV/AIDS drugs and could not raise the price of the drug in other countries whose governments control drug prices. In addition, Abbott officials said that the price increase is intended to recoup losses from patients who are taking smaller than expected doses of Norvir. "To continue the work in HIV and other therapeutic areas, we decided the appropriate thing to do to resource our program was to make up our losses with the price increase," Dr. John Leonard, an Abbott vice president in charge of drug development, said. However, James Love, director of the Consumer Project on Technology, said that because Norvir was developed with the help of a grant from NIH, "it should be cheaper in the United States." Love will testify before the reimportation panel Wednesday. Reimportation advocates contend that reimporting Norvir is the only way to make the drug affordable for people in the United States, according to the Times. However, Alan Holmer, president of the Pharmaceutical Research and Manufacturers of America, said, "The cost of AIDS medicines today is what funds the research for the better treatments and cures for tomorrow," adding, "It's true that other developed countries are free-riding on American research and we need to address that, particularly in trade agreements." Norvir also will be the subject of a yet-to-be-scheduled NIH hearing on whether the federal government should "take the unusual step" of allowing generic versions of the drug before its patent expires, the Times reports. According to the Times, because Norvir was developed using federal funds, the U.S. government has the right to demand "reasonable" prices for the drug but has never taken such a step (New York Times, 4/14).

Canadian Internet pharmacies that sell to U.S. consumers are looking to Europe for prescription drugs after several drug companies limited their shipments to such pharmacies, the AP/Detroit Free Press reports. Pfizer, Eli Lilly and AstraZeneca all recently have taken steps to limit supplies to Canadian pharmacies selling to U.S. customers, the AP/Free Press reports. In response, Canadameds.com will begin selling drugs from England on its Web site within the next week. Universaldrugstore.com will begin selling drugs from Ireland in the next month and might begin selling drugs from New Zealand. Crossborderpharmacy.com is negotiating with several pharmacies in England and intends to announce an agreement in three weeks. Officials for all three Canadian pharmacies said that they have investigated the safety and regulatory standards of the European pharmacies with which they will work. They also said that U.S. consumers will be given the option of purchasing the European drugs on their Web sites and that the treatments will be shipped directly from Europe to the consumers. According to the Canadian pharmacy officials, prices of the European medicines will be less than in the United States, but some drugs might be more or less expensive than their Canadian counterparts. Jeff Trewhitt, a spokesperson for PhRMA, said that, like drugs from Canada, drugs from Europe could be counterfeit or unsafe because of improper labeling or storage, the AP/Free Press reports (Agovino, AP/Detroit Free Press, 4/14).

FDA on Tuesday began implementing its "Looks Can Be Deceiving" program against reimportation in Virginia, the Richmond Times-Dispatch reports. As part of the campaign, 1.5 million fliers and other materials warning consumers about the possible dangers of reimporting drugs will be distributed to 1,500 pharmacies in Virginia. The campaign's slogan is: "Remember, medicines you buy outside the United States may be unsafe or ineffective. It's not worth risking your health!" The FDA program has been implemented in California, Illinois, Maryland and Texas (Hostetler, Richmond Times-Dispatch, 4/14).