Feds: Regulating Drug Imports Too Costly

WASHINGTON -- President George W. Bush dangled his support for legalizing prescription drug imports before voters during this year's campaign, but his administration declared Tuesday it's too costly to do safely.

Regulating the purchase of prescription medicines from abroad would wipe away most savings and diminish investment in new drugs, said a report from an administration task force studying the feasibility of legalized drug imports.

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

Proponents of drug imports, including some Republican lawmakers, said the report's conclusions were not surprising because many task force members have been staunchly opposed to importation. "It sounds like PhRMA could have written the report," Rep. Jo Ann Emerson, R-Mo., said, referring to the drug industry trade group.

An Associated Press poll this year found that nearly two-thirds of those surveyed said the government should make it easier to buy cheaper drugs from Canada or other countries.

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.

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.

Bush said during the campaign that he would wait for the report before making up his mind about drug imports as a way to help bring down prices. Many top-selling, brand-name drugs are at least one-third cheaper in Canada and elsewhere.

"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 in response to a question 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."

Lawmakers inserted a provision in last year's Medicare prescription drug law requiring the report to mollify colleagues who back drug imports. They set a December deadline to insure that Congress would not have to deal with the issue until after the election.

But the fierce partisan fight over the Medicare law and continued increases in prescription prices helped keep drug imports in the spotlight during the year.

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."

Evans and Thompson also put forward a Bush administration favorite as a remedy for high drug prices. "Congress should take steps to address the cost of excessive litigation," they wrote.

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.

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.

Advocates for opening the borders to prescription medicines said the report ignores the reality that Americans are buying cheaper drugs from abroad safely. "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, R-Minn., said.

Minnesota Gov. Tim Pawlenty, a Republican, said the federal government is sticking its head in the sand. He said he understands the concerns for safety, but "Canada and other developed Western nations have safeguards that keep their citizens safe. Again I say to the feds 'show me the dead Canadians."'

The American Medical Association, however, said it was "pleased with the report's 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 issued Tuesday night.

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, R-Tenn., a surgeon, refused to allow a vote in the Senate. For more information, click on the Web site of the HHS Task Force on Drug Importation.