Tue 24 Feb 2004
ST. PAUL (AP) The Food and Drug Administration has sent Minnesota governor Tim Pawlenty a harsh warning, calling a state program to help Minnesotans buy low-priced prescription drugs from Canada “unsafe, unsound and ill-considered.”
The letter sent Monday stopped short of ordering a shutdown of the month-old Minnesota RX Connect Web site, which directs people to state-approved Canadian pharmacies, but urged Pawlenty to “reconsider your action.”
By endorsing foreign pharmacies and going “outside of our regulatory system,” the letter said, “you … shine a bright light on a path used not only by profiteers masquerading as pharmacists, but by outright criminals.”
The site will remain online despite the FDA’s complaints, state Human Services Commissioner Kevin Goodno said. He said nothing in the letter changed his opinion that the state is operating within the law.
“We feel very strongly that we’re right, so we have to stand up for what we believe,” he said.
An FDA associate commissioner who wrote the letter, Bill Hubbard, said the federal agency is not threatening legal action yet.
But, he said, “We think this letter is very strongly worded and makes the point that what he (Pawlenty) is doing is unsafe. … Obviously, it would be a good thing if he stopped.”
What the FDA fails to recognize, Goodno said, is that Minnesotans already were purchasing discount drugs from questionable sources, both domestically and abroad, in their search for affordable medicine. “We decided to step in as a state and be a source of reliable information,” he said.
Hubbard said that should the state persist in directing Minnesotans to foreign pharmacies, “this is a potential violation of the law.” While FDA officials want to work with the state, he said, they cannot tolerate wholesale defiance of the law.
Pawlenty issued a statement late Monday calling the FDA’s letter “good news” because it fell short of legal action to shut down the state’s Web site.
“We appreciate FDA’s critique of our effort but disagree with their conclusions,” Pawlenty said.
Pawlenty was in Washington, where he was due to co-host a prescription drug summit Tuesday for other governors with Illinois Gov. Rod Blagojevich, who has expressed strong interest in linking his state’s Web site to Minnesota’s. He said the governors of North Dakota, Michigan and Wisconsin had expressed a similar interest.
“The FDA has completely lost all perspective on this issue,” said Peter Wyckoff, executive director of the Minnesota Senior Federation metro region. About 6,000 members buy Canadian drugs through the federation’s Web site program, which has been in place for more than a year.
“I can’t imagine the state will close its Web site unless it is ordered to,” Wyckoff said. “If that happens, the FDA will be declaring war on efforts to control rising drug costs.
“They say they’re concerned about safety, but the fact is I’m not aware of anybody getting sick from tainted or counterfeit Canadian drugs. The problems I’m aware of have all been with drugs purchased in the U.S., not Canada,” he said.
The Minnesota RxConnect Online site is located at MinnesotaRxConnect.com.
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