FDA Warns Minnesota on Drug Importation

Published April 1, 2004

A strongly worded letter from the U.S. Food and Drug Administration (FDA) warned Minnesota Governor Tim Pawlenty (D) that his decision to establish a Web site offering prescription drugs from Canadian pharmacies is “unsafe, unsound and ill-considered.” The letter all but orders a shutdown of the Minnesota Rx Connect Internet site, launched in January, urging Pawlenty to “reconsider [his] action.”

By endorsing pharmacies “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.”

FDA Associate Commissioner Bill Hubbard, who wrote the letter, said the agency is not threatening legal action at this point. Hubbard told the Minneapolis Star Tribune, “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.”

But Minnesota Human Services Commissioner Kevin Goodno said, “We’re not shutting this Web site down.”

Hanging Tough

“We think we’re within the law,” Goodno said, “and nothing in this letter changes my opinion of that.” Acknowledging the FDA could bring civil action against the state, Goodno defended the Web site, saying, “We feel very strongly that we’re right, so we have to stand up for what we believe.”

Hubbard said that if the state persists in directing Minnesotans to foreign pharmacies, “this is a potential violation of the law.” (See “Drug Reimportation Remains Illegal,” Health Care News, February 2004.)

While FDA officials want to work with the state, they cannot tolerate wholesale defiance of the law. Hubbard told the Star-Tribune he could not predict whether legal action would be taken against the state, but he did say the agency is not about to let the state off the hook.

Pawlenty issued a public statement from the National Governors Association meeting in Washington, DC, saying, “Today’s communication from the FDA is good news because it is not a legal action designed to shut our state Web site down. We appreciate FDA’s critique of our effort but disagree with their conclusions.”

Pawlenty went on with his business in Washington, co-hosting a prescription drug meeting with fellow governors Rod Blagojevich (D-Illinois), John Hoeven (R-North Dakota), Jennifer Granholm (D-Michigan), and Jim Doyle (D-Wisconsin). All have expressed interest in linking to Minnesota’s Web site. On February 25, Doyle added several Canadian pharmacies to the state’s prescription drug savings Web site, www.drugsavings.wi.gov. On February 27, local newspapers were reporting the site received more than 80,000 hits after linking to the Canadian pharmacies.

Pushing the Envelope

Pawlenty said he had been warned the FDA might take action against the state and confessed he was nervous. “I was hoping the FDA would just let us coast along a bit.” If a half-dozen states jump on Minnesota’s bandwagon, Pawlenty thinks the FDA will support the effort in some fashion.

Pawlenty has been pushing the envelope ever since he advanced the idea for a Web site allowing state residents to buy price-controlled drugs from Canada. His original idea was to also lower the state’s drug costs by having state workers fill their prescriptions across the border.

When told this would be a deliberate violation of federal law, Pawlenty backed off and instead tried to make the case that Minnesota’s Web site should be considered a pilot project.

Twila Brase, R.N., president of Citizens’ Council on Health Care in St. Paul, Minnesota, criticized Pawlenty’s action. She told Health Care News, “To encourage the purchase of drugs from Canada is to put a stamp of approval on price controls. In other words,” she said, “the antithesis of free-market policy.”

Brase added, “While Governor Pawlenty’s idea is politically popular, his administration should put their collective heads together to come up with solutions that don’t depend on or endorse the socialization of health care.”

Rock and a Hard Place

“The FDA has completely lost all perspective on this issue,” complained Peter Wyckoff, executive director of the Minnesota Senior Federation metro region (MSF). About 6,000 MSF members buy Canadian drugs through the federation’s Web site program, which has been in operation for more than a year. “I can’t imagine the state will close its Web site unless it is ordered to. If that happens, the FDA will be declaring war on efforts to control rising drug costs,” Wyckoff said.

“We’re sympathetic to their concerns,” Hubbard responded. “This is a difficult issue. But there are other ways.” For example, Hubbard pointed out, greater efforts could be made to promote the use of approved domestic generic equivalents, which can be even cheaper than name-brand drugs purchased from Canada.

Conrad F. Meier is managing editor of Health Care News. His email address is [email protected].