August 20, 2004
Oregonians could buy lower-cost medication from Canada through local pharmacies under a proposal Gov. Ted Kulongoski forwarded Thursday to the Bush admin- istration.
The proposal was greeted with skepticism by the Food and Drug Administration, which has questioned the safety of allowing U.S. consumers to access prescription drugs from beyond the nation's borders.
Kulongoski requested a federal waiver to allow Oregon to import federal Food and Drug Administration-approved medications under what he called the "Pioneer Prescription Drug Project." The Democratic governor also asked that the feds respond within 30 days.
Kulongoski said the feds' approval represents the final step necessary "for us to provide the relief Oregonians need from the skyrocketing price of prescription drugs."
Kulongoski's health policy adviser, Dr. Bruce Goldberg, said Oregonians could realize savings of between 25 percent and 60 percent. Pharmacists, who voluntarily choose to participate in the program, would be able to offer Canadian as well as generic alternatives to a name-brand drug. Goldberg said the program would initially be open only to those without insurance coverage for prescription drugs because they face the steepest costs.
"These are the ones who are most vulnerable and facing the highest cost for health care out of everybody," said Goldberg, who is administrator of the Office for Oregon Health Plan Policy and Research.
An FDA official said that while he would need time to assess Oregon's waiver request, on first glance it appeared to carry the same shortcomings as those from other states, such as Rhode Island where a newly passed law allows for drugs from Canada to be sold in the United States.
"We told the folks in Rhode Island it would be both ill-considered and cause the importation of potentially dangerous drugs," said William Hibbard, the FDA's associate commissioner for policy and planning.
Hibbard said Oregon and other states that have proposed to import only "FDA-approved" drugs would most likely be unable to fully ensure the safety of such medications, since the federal agency could not vouch for the safety of drugs that have been manufactured outside the country.
U.S. Rep. Peter DeFazio, D-Ore., said he would push federal regulators to approve the waiver. He chided the Bush administration for using "scare tactics" by claiming reimported drugs from Canada were unsafe.
"The truth is that the drug supply chain in Canada is safer and more closely regulated than the drug supply chain in the U.S.," DeFazio said.
Goldberg said that while Oregon officials shared the feds' concerns that only safe drugs should be available to U.S. patients, the state's plan had adequate safeguards to assure that that would happen.
Oregon's regulatory body, the Board of Pharmacy, would impose stringent licensing requirements for Canadian pharmaceutical wholesalers, he said. Those wholesalers allowed to sell drugs from Canada to Oregon pharmacies would be required to meet the same safety standards the Board of Pharmacy requires of U.S. wholesale drug outlets. Goldberg said that would make Oregon's proposal unique among those being pursued by various states.
"This is different from what other states have done, and that's where we believe we are meeting the same safety standards," he said.
Maribeth Healey of the union-backed group Oregonians for Health Security, said Kulongoski's proposal had promise to help Oregon consumers. She said the long-term solution, however, would not be to let U.S. consumers access lower-priced drugs from other countries, but to use the same tactics as those in Canada and most other nations: set limits on what pharmaceutical companies can charge or allow governments to negotiate for lower prices through bulk purchasing.