Sen. Judd Gregg Introduces Bill To Allow Prescription Drug Reimportation From Canada, Europe
As expected, Senate Health, Education, Labor and Pensions Committee Chair Judd Gregg (R-N.H.) on Wednesday introduced a bill that would allow the reimportation of lower-cost prescription drugs from Canada and 15 European Union nations, the AP/Manchester Union Leader reports (AP/Manchester Union Leader, 6/3). The legislation 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 (California Healthline, 6/2). 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 co-sign prescriptions for reimported medications (Heil, CongressDaily, 6/3). The legislation would not penalize pharmaceutical companies that limit the number of prescription drugs available for reimportation (Sherman, AP/Kansas City Star, 6/2). According to Gregg, FDA officials have agreed to support the legislation, the AP/Union Leader reports.
The legislation marks the third reimportation bill introduced in the Senate (Zaneski, Baltimore Sun, 6/3). A bipartisan bill (S 2328) introduced in April by Sen. Byron Dorgan (D-N.D.) would allow U.S. residents to 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). Sen. Chuck Grassley (R-Iowa) and Sen. John McCain (R-Ariz.) also have introduced reimportation bills (Baltimore Sun, 6/3). Gregg said that he plans to move the legislation through the Senate HELP Committee "before the summer's political conventions" in late July, according to the AP/Star. Senate Majority Leader Bill Frist (R-Tenn.) has not committed to a vote on the bill, although he asked Gregg to prepare the legislation (AP/Kansas City Star, 6/2).
The legislation has received "only Republican support," but "it is too soon to assess" whether the legislation will receive adequate bipartisan support to pass in the Senate, Reuters/Arizona Daily Star reports (Reuters/Arizona Daily Star, 6/3). Gregg said, "The fee structure for the FDA, we don't think is onerous," adding that the fees would have only a small effect on the profits of pharmaceutical companies. Sen. Norm Coleman (R-Minn.), a co-sponsor of the bill, added, "While no system is foolproof, I have confidence that the safety provisions in this bill effectively address most of my concerns." New Hampshire state Sen. Burt Cohen (D) added that the bill would provide a "temporary fix" to the issue of high prescription drug costs (AP/Union Leader, 6/3). However, Dorgan said that the legislation would not allow an adequate number of reimported medications, adding, "There are a lot of ways to write this to make sure reimportation doesn't happen" (CongressDaily, 6/3). Peter Corr, vice president of science and technology at Pfizer, said, "The whole issue of importation is frankly about importing price controls," adding, "If we want to have price controls, we should just have price controls in the [United States] and not put the population at risk" (Bloomberg/Boston Globe, 6/3).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.