Bush Administration Suggests Limited Drug Imports

WASHINGTON —  The Bush administration opened the door a tiny crack Tuesday to granting consumers legal access to lower-cost prescriptions from abroad, but it proposed such tight restrictions that congressional backers of the idea reacted angrily.

“I don’t know whether to describe this as an insult or an embarrassment,” said Rep. Gil Gutknecht (R-Minn.), one of a growing number of Republicans who say they are willing to confront President Bush about whether Americans should be able to buy imported brand-name drugs.

Such drugs are commonly priced 35% to 55% below U.S. market prices.

In a letter to congressional leaders, the administration said it might accept an import program if it were limited to a specified list of drugs and if the drugs came only from Canada, following protocols to be laid down by the Food and Drug Administration. Individuals would not be allowed to import their own medicines, but would have to go through authorized pharmacies, which would deal with Canadian wholesalers.

Although it is technically illegal to do so, Americans import an estimated 10 million shipments of medicines a year, valued at close to $1.5 billion. About half the trade is with Canada.

“If Congress is willing to consider imports from Canada, then it must be regulated much like the FDA regulates the American movement of pharmaceuticals, so that manufacture, storage and shipment are all within U.S. guidelines,” said Surgeon General Richard H. Carmona, who led an administration task force that spent 10 months studying the issue.

“It could be done safely if it is structured, if it is regulated,” Carmona said. “Right now, the only trading partner we could possibly see doing that safely with would be Canada.”

The administration’s letter accompanied a report from Carmona’s task force that was mainly a compilation of arguments against allowing freer access to drugs from abroad. It cited anecdotal evidence of safety problems and worries about taking away the drug industry’s economic incentive to develop medications.

It also predicted that middlemen would get most of the profits, resulting in meager savings to patients in the U.S.

Brand-name drugs are cheaper in many other industrialized countries because their governments set the prices that pharmaceutical companies can charge. That forces drug makers to seek the bulk of their profits from U.S. consumers.

Defying the federal government, several local governments have set up programs for their employees to buy drugs from abroad. In California, Gov. Arnold Schwarzenegger recently rejected legislation that would have allowed Canadian prescriptions into the state.

The importation debate has split Republicans, pitting populists against pro-business lawmakers. Bush had hinted during the presidential campaign that his administration might soften its stance against imports, but Tuesday’s bid appeared to fall short.

“If you think there is a single senior in Minnesota who is going to read this report and say, ‘Oh boy, I guess I’ll stop getting my Prilosec from Winnipeg,’ then you’re living in a fool’s paradise,” said Gutknecht. Prilosec is a medicine for heartburn.

The issue is especially important for GOP lawmakers from the states bordering Canada.

Sen. Olympia J. Snowe (R-Maine) called the administration report a disappointment. Snowe said Europe could provide a model for a U.S. import system. It has allowed shipping of prescription medicines across borders for 30 years by regulated dealers, with no serious problems. “America is certainly up to this challenge,” Snowe said.

Democrats sensed a political opening. Sen. Byron L. Dorgan (D-N.D.) said he would reintroduce legislation next year to allow importation of FDA-approved drugs.

Dorgan has hinted that he may try to hold up the confirmation of Mike Leavitt as secretary of Health and Human Services unless Senate Majority Leader Bill Frist (R-Tenn.) agrees to a vote on drug imports.

“Millions of Americans obtain prescription medicines from Canada and other countries and do so safely,” said Dorgan. “The federal government itself is buying flu vaccine from abroad right now. The only thing endangered ... is the incredibly large profits of the drug companies.”

The Pharmaceutical Research and Manufacturers of America, an industry group, said Carmona’s report and a companion economic analysis from the Commerce Department validated its concerns.

“These reports substantiate that importation proposals represent a false promise to American consumers,” said Dr. Paul Antony, the group’s chief medical officer. Industry officials point out that many brand-name drugs have generic alternatives that are sometimes less expensive than imports.

Administration officials are hoping that demand for drugs from abroad will ease once the new Medicare prescription drug benefit goes into effect in 2006. The elderly are the heaviest consumers of prescription medicines.

But Gutknecht said that was wishful thinking. “It’s not just about seniors,” he said. “I’ve heard from an awful lot of working people, especially those with a sick child.” The House has previously passed legislation allowing drug imports, but the measure never came to a vote in the Senate.

Tuesday’s letter to Congress, signed by Health Secretary Tommy G. Thompson and Commerce Secretary Don Evans, carried a pointed warning that Bush might veto legislation that did not meet the administration’s requirements.

That would be a mistake, said Gutknecht. “This could be a huge issue in the next elections,” he said. “I think Republicans could get hurt really badly unless they get out in front of things.”