The Bush administration dug in its heels yesterday against importation of prescription drugs from Canada and other countries, questioning the savings and safety of such purchases.
Confronting the growing public and bipartisan popularity of such imports, the administration - which prior to last month's election suggested it could embrace importation - reverted to its earlier opposition and warned that legalization would hinder the development of new medicines.
In response, supporters of drug importation accused the administration of taking a "one-sided" approach that favors the U.S. pharmaceutical industry.
The Department of Health and Human Services stopped short of promising legal action against states - including Illinois, Wisconsin and Minnesota - that have defied government regulations and set up drug purchase programs with Canadian pharmacies. An administration spokesman said the department is leaving the door open to suits.
In a report submitted to Congress, the department outlined its concerns and objections to prescription drug imports, which amounted to $700 million last year from Canada alone, through Internet sales and personal travel.
"It would be extraordinarily difficult and costly for 'personal' importation to be implemented in a way that ensures the safety and effectiveness of the imported drugs," the HHS Task Force on Drug Importation said.
The 145-page report, unveiled in Washington by U.S. Surgeon General Richard H. Carmona, cited significant risks from importing drugs and long-term damage to the leadership role the U.S. drug industry plays in developing new medications. Although Carmona said he could not point to specific instances of people dying from imported drugs, he said there is a "great, great potential of harm" from people buying imported drugs.
Only two months ago President Bush, in the heat of the election campaign, left open the possibility of supporting drug importation. "Now, it may very well be here in December you'll hear me say, I think there's a safe way to do it," Bush said during the Oct. 8 presidential debate in St. Louis.
Now there is no doubt about the White House position.
The report provoked sharp responses from supporters of drug importation. The Alliance for Retired Americans said the report "stiffs" seniors who have sought to buy needed medications more cheaply in Canada.
Rep. Rahm Emanuel, an Illinois Democrat, joined a chorus of House members, saying it is "ironic that two weeks after the HHS announcement that millions of flu vaccine doses will be imported from Germany, HHS is releasing a report creating major roadblocks to drug importation." They called the report "one-sided" and said it reflects a commission that was made up entirely of opponents of drug importation.
A spokeswoman for Democratic Illinois Gov. Rod R. Blagojevich said the report's findings were not surprising, given the administration's previous statements, but added it would not deter Illinois efforts to seek cheaper medications abroad.
Under U.S. law, it is illegal for consumers to import prescription drugs. But the government, probably sensing the popularity and political sensitivity of the issue, has not moved to stop the traffic, nor has it moved against states and cities that have arranged drug purchase arrangements with Canadian pharmacies.
The nation's tab for prescription drugs has been increasing at a rate of 10 percent to 15 percent annually for several years, and Canada, where popular drugs can be bought at savings of 30percent to 70 percent, is a natural alternative. A recent study showed that 34 percent of Americans who buy prescription drugs are obtaining them from Canada or other nations.
The administration's challenge to the safety of drugs from other countries comes as questions have mounted recently about the reliability of drugs produced in the United States and blessed by the Food and Drug Administration, the chief regulatory agent.
On Monday, the FDA warned consumers not to exceed the recommended dose of naproxen, sold over the counter under the brand name Aleve, because clinical tests show the drug might increase the risk of heart attacks and stroke. There were earlier warnings about the popular Celebrex and Vioxx arthritis pain relievers.
The debate over importation has been simmering for two years, creating political fractures. Last year the House approved a bill legalizing importation but the Senate, under Majority Leader Bill Frist, a physician, blocked it.
While the White House points to benefits contained in the Medicare prescription drug law, critics point out that it does not take effect until 2006 and complain that many seniors will not benefit.
Tribune national correspondent Jill Zuckman contributed to this article. The Chicago Tribune is a Tribune Publishing newspaper.