St. Paul, Minn. — Pawlenty's proposal adds significant momentum to a national drive to open the doors to prescription drug imports from Canada and other countries. The governors of Illinois and Iowa -- both Democrats -- are pursuing similar plans. Pawlenty's announcement makes him the first Republican governor to join the movement.
"And, yes, this will ruffle feathers. There's no question about that, including some of... our good friends in the Bush administration. But we feel strongly enough about this that we're going to forge ahead in any event," Pawlenty said on Wednesday.
Pawlenty didn't have exact figures for how much the state might save by relying on cheaper foreign drugs. But he says the figures could run into the tens of millions of dollars per year.
Pawlenty envisions a plan in which state employees and those receiving state-subsidized healthcare could purchase drugs from approved foreign sources. They would then be reimbursed by state-funded health plans. He also has asked administration officials to examine how such a proposal could be expanded to include all Minnesota citizens. But President Bush has resisted attempts to loosen import controls on foreign drugs.
William Hubbard, a senior associate commissioner at the Food and Drug Administration, says the administration is mainly concerned that imported medications won't meet guidelines established for the U.S. market.
"When you go offshore to buy drugs, you lose all those regulatory protections. And further the foreign countries, including Canada, that might assure the safety of exports say they can't and won't. So therefore the patient or consumer that buys these drugs is doing so totally in trust of the person that sells it to them," he says.
The Pharmaceuticals Research and Manufacturers of America also cites safety concerns in opposing the governor's plan.
Pawlenty says he'll only proceed with an importation plan if he can be sure it's both safe and legal. He's asked Attorney General Mike Hatch and Human Services Commissioner Kevin Goodno to examine potential hurdles. And while Pawlenty acknowledges the FDA has a role in regulating drug imports, he says says he find's it difficult to believe that Canadian drugs would be suspect.
"We're going to pay deference to the FDA. But we're also going to challenge them, and say we're not talking about a country that is remote or primitive in its regulatory or business practices. We're talking about a country that is closer to us in key respects than California," Pawlenty says.
Pawlenty says state regulators could even produce a list of foreign pharmacies approved for Minnesota consumers to help address safety concerns. The FDA's Hubbard says that would help offset the Bush administration's concerns. But he remained slightly skeptical.
"There are ideas out there that we have heard and some we've proposed that ameliorate our safety concerns and lessen them. However, you're still -- no matter what you do if you access foreign drugs is you're still going around a very-well established, proven safety system," says Hubbard.
Hubbard stressed that the various proposals in Illinois, Iowa, and Minnesota remain ideas under discussion and not much more at the moment. Hubbard says it's too early to say whether the FDA would take any regulatory or legal action to block the plans if they move foward.
But health care activist Kip Sullivan says the FDA has little ground to stand on. Sullivan helped arrange trips to Canada for Minnesota seniors in the mid-'90s. He says the FDA doesn't have as much power to block imports as the administration has claimed.
"It is beginning to dawn on people, including, I presume, Gov. Pawlenty, that the FDA ... there's something fishy about the FDA's position, something ambiguous and unclear. And it's time to challenge it and get clarity," according to Sullivan.
Sullivan says the senior trips continue today with little interference.