A Bush administration task force said Tuesday that the safety of widespread drug importation (search) could not be assured and the practice would save little money.
Officials say that it cannot be done safely without massive amounts of federal spending and that actual cost savings for consumers would be minimal.
In a report delivered to members of Congress, a 13-member task force made up of administration officials concluded that there was essentially no way for the FDA to effectively police drug packages imported from Canada and elsewhere by individual consumers.
The report leaves the door open to importation by established commercial entities, such as drug wholesalers, under highly limited circumstances that appear to be non-negotiable from the administration’s point of view. They include restricting importation to high-cost, popular drugs, establishing clear records of every stop along the drug shipment chain, and avoiding price controls opposed by drug companies and the White House.
Millions of Americans have turned to buying drugs from Canada, where brand-name prescriptions can sometimes be filled for half the U.S. cost. While the practice of drug importation remains illegal, regulators have turned a blind eye to individuals who try to save money by importing less than a 90-day supply at one time.
But the report also warns that the U.S. would only save 1 to 2 percent on its total drug costs by allowing for wholesale importation and at the same time would have to spend “several hundred million dollars” to boost the FDA’s ability to properly monitor it, according to a senior administration official who briefed reporters.
“Overall national savings from legalized commercial importation would likely be a small percentage of total drug spending,” says surgeon general Richard Carmona, MD, who chaired the report task force.
Congress has already passed legislation allowing for some prescription drug importation, though the law was never put into effect because of a provision requiring the Health and Human Services secretary to certify that imported drugs pose no health risk to consumers.
Lawmakers last year ordered the administration to review the potential for legalizing drug importation, an effort that culminated in Tuesday’s report. The 145-page document also appeared to serve as a list of demands should Congress move to pass popular importation legislation again.
In a letter to House and Senate leaders accompanying the report, Health and Human Services Secretary Tommy G. Thompson and Commerce Secretary Donald Evans warned that White House advisors would recommend that President Bush veto any legislation that does not fully address the task force report.
Bush administration officials have never taken a positive view of drug importation, warning that it is potentially unsafe and could damage the ability of private drug companies to invest in research and development.
But the report represents a final position on the issue from President Bush, who said during his second presidential debate with Sen. John Kerry on Oct. 9 that he might agree to allow drug importation if the task force concluded that it could be done safely.
Tuesday’s report says that importation by individual consumers -- now widely practiced through Internet sales and, in some cases, via personal trips north of the border -- cannot be safely legalized.
Congress has debated several measures allowing for personal importation. Sen. Byron Dorgan, D-N.D., a leading proponent of legalized importation, attacked the report as biased and vowed to reintroduce a bill authorizing drug importation when Congress convenes next year.
"Of course it can be done safely," Dorgan says. "Millions of Americans obtain prescription medicines from Canada and other countries every year and do so safely. The federal government itself is buying flu vaccine from abroad right now. The only thing endangered by allowing Americans’ access to lower-priced FDA-approved medicines from abroad is the incredibly large profits of the drug companies who overprice their medicines inour market, just because they can."
By Todd Zwillich, reviewed by Michael W. Smith, MD
SOURCES: HHS Task Force on Drug Importation Report on Drug Importation, Dec. 21, 2004. Senior administration official. Richard Carmona, MD, surgeon general. Tommy G. Thompson, Secretary, U.S. Department of Health and Human Services. Donald L. Evans, Secretary, U.S. Department of Commerce. Sen. Byron Dorgan, D-N.D..
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