AARP To Endorse Senate Bill To Allow Reimportation of Prescription Drugs From Other Nations

Officials for AARP on Tuesday announced that the 36 million-member organization will endorse a bill (S 2328) that would allow the reimportation of prescription drugs from other nations, the Boston Herald reports (Heldt Powell, Boston Herald, 6/16). Under the bill, sponsored by Sen. Byron Dorgan (D-N.D.), U.S. residents could reimport as much as a 90-day supply of prescription drugs from FDA-approved Canadian pharmacies for personal use. After 90 days, the legislation would allow licensed pharmacists and prescription drug wholesalers to reimport medications from Canada. In addition, U.S. residents who travel to Australia, Japan, New Zealand, Switzerland or current European Union nations could return with as much as a 90-day supply of prescription drugs for personal use. After one year, pharmacists and wholesalers could reimport medication from Australia, Japan, New Zealand, Switzerland or European Union nations that were members as of Jan. 1, 2003. Pharmacists and wholesalers that reimport prescription drugs would have to register with FDA; pay fees of as much as 1% of the price of the medications to fund the cost of additional federal inspectors and customs agents; and track and document the chain of custody of medications from manufacturer to consumer (California Healthline, 6/1).

AARP on Wednesday will officially announce the endorsement of the bill at a news conference, CQ Today reports (Schuler, CQ Today, 6/15). Steve Hahn, a spokesperson for AARP, said, "Our members want lower drug costs, and this is one of many measures that can help get them" (Washington Post, 6/16). Hahn said that AARP officials have worked with cosponsors of the bill to strengthen some safety provisions in the legislation, adding that "some changes have already been made," CQ Today reports. In addition, Hahn said that AARP officials plan to "talk about the merits of the (reimportation) bill and to give the senators their due credit" at the news conference (CQ Today, 6/15). Sen. Edward Kennedy (D-Mass.), a cosponsor of the bill, said that the AARP endorsement "is another indication of the political power of this issue and its importance to senior citizens" (Boston Herald, 6/16). Sen. John McCain (R-Ariz.), also a cosponsor of the bill, said that the AARP endorsement might help convince congressional leaders to act on reimportation legislation, adding that "there's only one thing that matters, and that's votes -- and we have them" (Heil, CongressDaily, 6/16).

However, pharmaceutical industry officials called the AARP endorsement a "setback," the Herald reports (Boston Herald, 6/16). The endorsement also "deals a blow" to a "more restrictive" rival bill introduced by Senate Health, Education, Labor and Pensions Committee Chair Judd Gregg (R-N.H.), CongressDaily reports (CongressDaily, 6/16). The Gregg bill would require FDA to establish a system to allow the reimportation of prescription drugs from Canada within one year and the reimportation of medications from the European Union nations within three years. In addition, the bill would require pharmaceutical companies, prescription drug wholesalers and other entities involved in reimportation to register with FDA and pay a fee that would supplement the cost of implementation and maintenance of the system. The legislation would only allow the reimportation of FDA-approved medications from FDA-approved manufacturing facilities. The legislation also would require pharmaceutical companies to label reimported medications separately from other U.S.-manufactured treatments. The bill would allow HHS Secretary Tommy Thompson to restrict, inspect and control the ports of access through which reimported medications enter the United States. In addition, the legislation would require online pharmacies to obtain licenses and would mandate that physicians in other nations cosign prescriptions for reimported medications. The legislation would not penalize pharmaceutical companies that limit the number of prescription drugs available for reimportation (California Healthline, 6/3). FDA Director of Pharmacy Affairs Tom McGinnis raised concerns that neither of the two Senate bills would provide the agency with adequate resources to ensure the safety and effectiveness of reimported prescription drugs. He added that the Dorgan bill likely is not "implementable" because the 1% cap on fees paid to FDA by wholesalers and pharmacists would not provide the agency with adequate funds (CongressDaily, 6/16).

The three Canadian pharmacies listed on the Wisconsin prescription drug Web site shipped unauthorized prescription drugs to state residents, "underscoring federal concerns about state and local programs that encourage" reimportation, the AP/Las Vegas Sun reports (Frommer, AP/Las Vegas Sun, 6/15). The three pharmacies -- Vancouver-based Granville Pharmacy, Winnipeg-based CanadaDrugs.com and Calgary-based Total Care Pharmacy -- also appear on similar Web sites administered by Minnesota, New Hampshire and San Francisco (California Healthline, 6/15). FDA on Tuesday released separate letters dated April 27 from the Wisconsin Department of Health and Family Services that informed the three pharmacies they had shipped generic medications not approved for sale in the United States. In addition, the state health department cited CanadaDrugs.com for improper shipment of insulin, which requires refrigeration, to a Wisconsin resident. FDA Associate Commissioner William Hubbard said that the letters confirm "our concerns that people are promised high standards, and they don't get them." However, Dan Leistikow, a spokesperson for Wisconsin Gov. Jim Doyle (D), said that the letters indicate the "state is being vigilant in ensuring that the agreement is being followed and that we have a safe system in place." Leistikow added that three pharmacies have corrected the problems and that the state health department has found no additional violations since the letters were sent (AP/Las Vegas Sun, 6/15).