Senators Introduce Bill To Allow Reimportation of Prescription Drugs From Other Nations
As expected, a bipartisan group of senators on Wednesday introduced a bill (S 2328) that would allow the reimportation of prescription drugs from other nations, the New York Times reports (Pear, New York Times, 4/22). The group includes Senate Minority Leader Tom Daschle (D-S.D.) and Sens. Edward Kennedy (D-Mass.), Byron Dorgan (D-N.D.), Debbie Stabenow (D-Mich.), Tim Johnson (D-S.D.), Mark Pryor (D-Ark.), Russell Feingold (D-Wis.), John McCain (R-Ariz.), Olympia Snowe (R-Maine), Lincoln Chafee (R-R.I.) and Trent Lott (R-Miss.) (Schuler, CQ Today, 4/21). The "Pharmaceutical Market Access and Drug Safety Act" would allow U.S. residents to reimport as much as a 90-day supply of prescription drugs from Canada for personal use (Shogren, Los Angeles Times, 4/22). However, U.S. residents could reimport medications only from FDA-approved Canadian pharmacies; the agency Web site would include a list of such pharmacies (New York Times, 4/22). 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 (Los Angeles Times, 4/22). After 90 days, the legislation would allow licensed pharmacists and prescription drug wholesalers to reimport medications from Canada. 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 and pay fees of as much as 1% of the price of the medications to fund the cost of additional federal inspectors and customs agents. In addition, pharmacists and wholesalers would have to track and document the "chain of custody" of medications from manufacturer to consumer, the Times reports. Under the bill, FDA could require pharmacists and wholesalers to use new technologies to block counterfeiters. The legislation also would provide the federal government with "sweeping new power" to punish pharmaceutical companies that attempt to block reimportation and would define such efforts as antitrust violations, the Times reports (New York Times, 4/22).
"Americans understand fairness, and they know it's wrong that Americans pay far too much for prescription drugs -- more than Canadians, more than the British, more than in any other country in the world," Kennedy said. "We're now well beyond the question of the necessity to allow for safe, regulated drug importation," Snowe said, adding, "A drug can be safe and effective, but what good is it if you can't afford to take it? It is simply unconscionable that American consumers are subjected to price discrimination" (Los Angeles Times, 4/22). Dorgan said that the bill "has a strong base of support to pass through the Senate" (Rovner, CongressDaily, 4/21). On Tuesday, Barry Piatt, a spokesperson for Dorgan, said that earlier this year Senate Majority Leader Bill Frist (R-Tenn.) promised Dorgan a vote on a reimportation bill in exchange for his decision to lift a hold on the nomination of Mark McClellan as CMS administrator (California Healthline, 4/21). Rep. Jo Ann Emerson (R-Mo.) said that for reimportation "to gain such support in the Senate is a major victory." Rep. Rahm Emanuel (D-Ill.) said that the new Senate bill and continued efforts by state and municipal officials to reimport medications makes the practice "inevitable." Both Emerson and Emanuel voted in favor of a bill (HR 2427) approved by the House last July that would allow reimportation from 25 industrialized nations (Rovner, CongressDaily, 4/22). John Rother, policy director for AARP, said that the decision by Lott to support the bill "is a signal to everybody" that such legislation will pass, adding, "Even Frist knows he doesn't have the votes to stop it anymore" (Radelat, Gannett/Tennessean, 4/21).
Alan Holmer, president of the Pharmaceutical Research and Manufacturers of America, said that the bill "opens the door for un-approved and un-traceable medicines to flow onto pharmacy shelves across America." He added, "This bill undercuts the FDA's ability to protect patients' health and will potentially allow foreign versions of medicines from over 22 countries into the United States, including medicines from places like Latvia, Estonia and Slovenia" (Rowland, Boston Globe, 4/22). Frank Palumbo, director of the Center on Drug and Public Policy at the University of Maryland School of Pharmacy, said that although the sponsors of the bill hope to reduce prescription drug prices for U.S. residents, "the fact of the matter is they're skirting the edges of a well-working regulatory process that is designed for the protection of the American public" (Barfield Berry, Long Island Newsday, 4/22). FDA Associate Commissioner William Hubbard said that because the bill would allow the reimportation of "equivalent" prescription drugs, the legislation would establish a two-tiered system in which those with health insurance receive FDA-approved medications but those who reimport treatments could "get medicines that are similar but not necessarily the same and might not work in the same way," CongressDaily reports (Rovner, CongressDaily, 4/22). Tom McGinnis, FDA director of pharmacy affairs, said that because the bill requires pharmacies that reimport medications to pay a $10,000 fee every six months, small pharmacies in rural areas "might be excluded" (Tumulty, Gannett/Detroit News, 4/22). He added that fees collected from pharmacies and wholesalers would not provide adequate funds to ensure the safety of reimported medications and that the bill sponsors never consulted with FDA officials about the legislation (Long Island Newsday, 4/22).
Sen. Chuck Grassley (R-Iowa) on Wednesday said that representatives from the pharmaceutical industry "intruded" on town meetings in Iowa held to provide beneficiaries with information about the new Medicare law and lobbied against a reimportation bill he has introduced, the Des Moines Register reports (Norman, Des Moines Register, 4/22). Earlier this month, Grassley introduced a bill (S 2307) that would allow U.S. residents to reimport medications from Canada. The legislation would establish a 90-day deadline for FDA to develop a system to register and inspect Canadian prescription drug suppliers. After that time, U.S. residents could purchase prescription drugs only from Canadian suppliers inspected and registered by FDA. After two years, the bill would allow the reimportation of prescription drugs from other nations, such as Australia, Japan and European Union nations. Under the bill, U.S. residents would have to obtain prescriptions from U.S. physicians before they could reimport medications and could only reimport FDA-approved treatments. The bill would not allow the reimportation of some prescription drugs, such as certain painkillers (California Healthline, 4/13). "We had drug company representatives show up and try to denigrate my efforts for the importation of drugs," Grassley said, adding that the "industry plants ... tried to take over the meeting." Grassley said that the pharmaceutical industry representatives, who at first did not identify themselves as representatives, attended four of the 12 meetings he held last week. However, Grassley refused to identify the pharmaceutical companies whose representatives questioned him about reimportation at the meetings. Officials from PhRMA did not comment on the issue (Des Moines Register, 4/22).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.