Sen. Judd Gregg Delays Markup Session for Prescription Drug Reimportation Legislation
Senate Health, Education, Labor and Pensions Committee Chair Judd Gregg (R-N.H.) on Monday delayed a markup session scheduled for Wednesday for a bill (S 2493) he has proposed that would allow the reimportation of prescription drugs because of a conflict with a White House bill signing ceremony for the Project BioShield Act (S 15), CongressDaily reports. Gregg may re-schedule the markup session for later on Wednesday, a spokesperson for the senator said. According to CongressDaily, the markup session has "long been in question" because some believe the bill does not have the required votes for committee approval. A number of committee members support a rival bill (S 2328) proposed by Sen. Edward Kennedy (D-Mass.) and a bipartisan group of senators that includes Sens. Byron Dorgan (D-N.D.), Olympia Snowe (R-Maine) and John McCain (R-Ariz.) (Heil, CongressDaily, 7/20).
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. Under the bill, HHS Secretary Tommy Thompson could 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 bill would not penalize pharmaceutical companies that limit the number of prescription drugs available for reimportation.
Under the Kennedy bill, which AARP has endorsed, 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, 6/17).
According to CongressDaily, although the existence of rival Senate reimportation bills this late in the legislative session in most years would "spell doom" for the legislation, late-session action this year "cannot be ruled out" because of the "popularity of the topic" and the "need for both parties to seek support from senior-citizen voters" (Heil, CongressDaily, 7/19).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.