U.S.: Drug Imports Can't Be Safe and Cheap

Consumers would see little savings from a government-sanctioned system of prescription drug imports from Canada, the Bush administration says.

But a growing number of consumers already get their drugs north of the border, where prices on brand-name medicines are at least one-third less, and aren't likely to change their ways, despite a report Tuesday from the administration depicting safety concerns with imported medicines.

Advocates for opening the borders to prescription drugs said the report ignores reality. "Call 1,000 seniors in Minnesota who currently get their drugs from Canada, I bet you won't find a single one who'd say tomorrow morning, 'You know, Hazel, I think we'd better quit buying it from Canada,'" Rep. Gil Gutknecht (search), R-Minn., said.

Ten million illegal shipments of prescription drugs worth $1.4 billion entered the United States in 2003, about half of them from Canada, the report said. Authorities have not prosecuted individuals who buy drugs abroad and inspectors are overwhelmed by the sheer number of packages.

Drug imports represent less than 1 percent of U.S. drug spending, but the number is five times greater than it was in 2001, the report said. A growing number of cities and states are helping employees and retirees buy drugs from Canada, over the objections of the Food and Drug Administration (search).

The administration recently negotiated the purchase of up to 4 million doses of flu vaccine from Germany to make up some of this year's shortage, but will require every patient to sign a consent form acknowledging the possibility of risks.

Lawmakers in both parties said they are convinced majorities in both houses of Congress support drug imports because of constituent complaints about fast-rising drug prices. Gutknecht and others said they would renew their push for importation legislation next year, despite opposition from Republican congressional leaders and the administration.

Several bills in the Senate would have permitted imports from Canada, where brand-name medicines cost one-third or more less. Legislation passed the House last year, but Senate Majority Leader Bill Frist (search), R-Tenn., a surgeon, refused to allow a vote in the Senate.

Medicare chief Mark McClellan, a member of the task force that produced the report, said none of the bills that have been introduced satisfies the administration's safety concerns.

Medicare's prescription drug benefit begins in 2006, and the administration is betting that older and disabled people, who consume most prescription medicine, will see sufficient savings to depress the drive for cheaper drugs from abroad. The importation report was part of last year's Medicare law.

The report severely limited the circumstances in which drug imports could be safe. Individual drug shipments through the mail and package services should not be made legal at all, the report said.

Commercial importation from Canada, using licensed wholesalers, could be considered, the report said. But the savings would be small because taxpayers would have to spend several hundred million dollars to increase substantially the regulation of drug manufacturers and distributors, the report said. Middlemen also would skim off most of the savings, it said.

Shipments of imports must require a drug pedigree to trace their path from manufacture to entry into the United States, the report said. The FDA, however, repeatedly has declined to put in place a requirement for drug pedigrees, instead relying on voluntary measures.

Consumers would be better off increasing their use of generic medicines, which often are cheaper in the United States than elsewhere, the report said.

Some opponents of importation said current questions about the FDA's ability to monitor the safety of drugs that can be sold legally in the United States provide even more reason to bar drug imports.

President Bush had dangled his support for legalizing prescription drug imports before voters during this year's presidential election campaign. He said he would wait for the report before making up his mind.

"And we've just got to make sure, before somebody thinks they're buying a product, that it works. And that's why we're doing what we're doing," Bush said at the second presidential debate. "Now, it may very well be here in December you'll hear me say, 'I think there's a safe way to do it.'"

In May, Health and Human Services Secretary Tommy Thompson said the president should not veto drug importation legislation, noting the political potency of the issue.

On Tuesday, Thompson and Commerce Secretary Don Evans — in a letter to Republican congressional leaders that accompanied the report — said Bush should veto legislation that doesn't address safety concerns.

HHS spokesman Bill Pierce said there was no contradiction between the statements. Thompson's earlier comment "was a general answer to a very general question."

The American Medical Association applauded Tuesday's report for its focus "on ensuring access to drugs that are safe and effective, as well as affordable."

"Patients must be protected from unapproved drugs that could be unsafe, expired, counterfeit, adulterated, misbranded or inappropriately labeled," AMA trustee Edward L. Langston said in a statement Tuesday night.