Senate Committee Approves Bill To Legalize Reimportation of Prescription Drugs
The Senate Commerce Committee on Thursday voted 14-8 to pass a Federal Trade Commission reauthorization bill that includes an amendment under which U.S. residents could reimport lower-cost prescription drugs from other nations, the New Orleans Times-Picayune reports (Alpert, New Orleans Times-Picayune, 7/22).
The bill would authorize $1.2 billion for FTC over five years. Sens. Byron Dorgan (D-N.D.) and Olympia Snowe (R-Maine) sponsored the amendment, which they had introduced as a separate bill (S 334) earlier this year (CQ Today, 7/21).
The amendment would allow residents to reimport prescription drugs for personal use from FDA-approved Canadian pharmacies. After 90 days, the amendment would allow licensed pharmacists and prescription drug wholesalers to reimport medications from Canada. After one year, pharmacists and wholesalers could reimport medications from Australia, Japan, New Zealand, Switzerland or EU 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 and track and document the chain of custody of medications from manufacturer to consumer. In addition, the amendment would phase in FDA review of notices of the foreign versions of FDA-approved prescription drugs to determine whether they are the same or different than current medications approved for use (California Healthline, 4/20).
The amendment also includes three provisions from a separate bill (S 109) introduced earlier this year by Sen. David Vitter (R-La.). The provisions would mandate that packages for reimported prescription drugs use counterfeit-resistant technologies and require the HHS secretary to designate nations other than Canada from which U.S. residents could safely reimport prescription drugs in the event that Canada ends or restricts sales of medications to the U.S.
Dorgan said, "Today's action makes clear there is strong bipartisan support for this legislation in the Senate." Vitter said that the amendment "will create leverage for our efforts" to legalize prescription drug reimportation, as the Senate "definitely wants to pass" the FTC reauthorization bill (New Orleans Times-Picayune, 7/22).
Committee Chair Ted Stevens (R-Alaska) opposed the amendment, which he said would threaten the passage of the FTC reauthorization bill. He also said that the committee does not have jurisdiction over prescription drug reimportation. Stevens added that either he or Senate Health, Education, Labor and Pensions Committee Chair Mike Enzi (R-Wyo.) will place a hold on the bill (CongressDaily, 7/21).