WASHINGTON — States leading the drive for legal purchases of lower-cost medicines from Canada are not backing down despite threats by federal regulators. One state health official accuses the Bush administration of raising "bogus" safety concerns to protect drugmakers' profits.

More than a dozen states are moving ahead with various programs. Some would direct their residents to approved drug sources in Canada. Some states intend to buy the drugs for state workers and retirees or help pharmacies purchase them.

The Food and Drug Administration and the Health and Human Services Department have threatened lawsuits and even criminal action to stop the states' plans.

The federal officials say importing any drugs from Canada, even those manufactured at FDA-monitored plants for sale in this country or handled by regulated Canadian pharmacies, would violate federal law and risk exposing consumers to tainted or fake products.

"This is going to be an unenforceable law," says Kevin Concannon, Iowa's director of human services. "The statements they make about consumer safety or drug safety are the most bogus words I've seen spoken from a government agency. ... There's more protection of pharmaceutical manufacturers than there is of patients."

The hardening positions on both sides signal a looming legal and political confrontation.

Governors in both parties want to lower their drug costs in a time of budget austerity as well as aid people who lack drug insurance. The Bush administration says any foreign purchases violate the law and erode the FDA's authority, a position countered by overwhelming support in opinion polls for cheaper drug imports.

"All that we are doing is enforcing the law as it is written," says William Pierce, spokesman for Health and Human Services Secretary Tommy Thompson.

"If Congress wants to give us the authority and resources to oversee an import program, we'll do that," FDA Senior Associate Commissioner William Hubbard says. There are moves in both houses of Congress to do that.

No state has directly challenged the administration's interpretation of the law yet, but state officials say federal regulators would have to back down. "It would just create a firestorm," Concannon says. "They would lose in the court of public opinion."

Iowa Gov. Tom Vilsack, a Democrat, hopes to begin a program next year authorizing local pharmacists to buy drugs from Canada.

Officials in New Hampshire, Minnesota and Illinois are developing programs to import cheaper drugs from Canada or to point consumers to approved Canadian retailers.

The Bush administration's latest expression of opposition to imports came in response to a request by Illinois Gov. Rod Blagojevich, a Democrat, who formally sought approval of a test program. Federal officials say the request is certain to be rejected.

A growing number of cities and states have voiced interest in Canadian drug purchases. Of the four states furthest along in their planning, two are headed by Republican governors who find themselves at odds with the Republican administration:

• New Hampshire Gov. Craig Benson "is committed to finding solutions to the prescription drug problems through reimportation of Canadian drugs," spokesman Wendell Packard says.

The state plans to have a Web site to help residents buy Canadian drugs next month.

• Minnesota Gov. Tim Pawlenty plans to establish a Web site by January steering state residents to Canadian retailers approved by Minnesota inspectors. "We believe the Web site is totally legal," says Jason Rohloff, Pawlenty's director of federal affairs.

Even advocates of legalizing imports don't see buying drugs in Canada as a long-term solution to high drug prices in the USA but as a way to pressure manufacturers to lower prices. Democrats also see it as a way to pressure Republicans in Congress and the White House on drug costs and to make the point that the new Medicare law does little to address drug prices.

Many governments, including Canadian provinces, negotiate prices with drugmakers. The United States does not, and the new Republican-sponsored Medicare law prohibits the federal government from negotiating drug prices. Concannon, the Iowa health official, calls that provision "appalling" in light of high prices charged to consumers who lack drug insurance and must pay retail prices or go without medicine.

Contributing: Julie Appleby

© Copyright 2003 USA TODAY, a division of Gannett Co. Inc.

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