It is impossible to ensure the safety of imported drugs purchased individually by American consumers, and even a federally run program of bulk importation would pose medical and...

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WASHINGTON — It is impossible to ensure the safety of imported drugs purchased individually by American consumers, and even a federally run program of bulk importation would pose medical and economic risks to consumers, according to a pair of reports released yesterday by Bush administration officials.

The reports were ordered last year by Congress after the GOP leadership thwarted efforts to pass legislation legalizing expanded importation. Their contents suggest that despite hints to the contrary during his re-election campaign, President Bush may be in no hurry to liberalize rules governing the importation of cheaper drugs.

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The reports do not close the door on easier importation. But they make plain that Canada is the only country in a position to serve as foreign supplier of reliable prescription drugs. And considering the expense of setting up even a limited system with that country — and the harm that it may cause to U.S. drug companies — consumers would ultimately benefit very little, the reports conclude.

“If Congress were to pass legislation that did not address the serious safety concerns … or if Congress were to pass legislation that discouraged innovation or stifled competition … the President’s senior advisers would recommend a veto,” wrote Health and Human Services Secretary Tommy Thompson and Commerce Secretary Donald Evans in a letter to congressional leaders accompanying the two reports.

Advocates of drug importation immediately denounced the reports as predictable position statements from the administration and the U.S. pharmaceutical industry. Lawmakers on both sides of the aisle predicted the reports would only inflame public sentiment against the Food and Drug Administration and the drug industry, and vowed to push harder than ever for legislation.

“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 Bush over the issue.

Rep. Jo Ann Emerson, R-Mo., referring to the drug industry trade group, said: “It sounds like PhRMA could have written the report.”

Added Sen. Byron Dorgan, D-N.D.: “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 in our market, just because they can.”

One of the two reports — by the HHS Task Force on Drug Importation, chaired by Surgeon General Richard Carmona — confirmed that drug importation is common. Nearly 5 million shipments valued at about $700 million, entered the U.S. from Canada in 2003, it said, and an equivalent amount is coming in from the rest of the world.

The problem, according to the report, is that most of those medicines were produced in laboratories and distributed by suppliers that are not inspected by the FDA, calling into question their purity and safety.

The FDA could never achieve proper oversight of so many individual shipments, the report said. The agency could, in theory, oversee a federal system of bulk shipments from a single nation — Canada — it said. But the cost of putting such a system in place and the added cut that new middlemen would take would leave consumers saving only 1 to 2 percent overall, it said.

Moreover, the report suggested, the resulting decline in profits for U.S. drug makers would force them to reduce their spending on research and development, ultimately depriving consumers of important new medicines.

That argument stirred cat calls yesterday, given recent revelations about the potential risks of some popular FDA-approved drugs such as Vioxx, Celebrex and Aleve.

“The authors of this report don’t cite a single example where an American has been harmed by an imported drug, and we have thousands of examples now where Americans were harmed by FDA-approved drugs,” Gutknecht said.

Also yesterday, the Commerce Department released a report that concluded that while prescription drugs are indeed considerably cheaper in other countries — in large part because of government-imposed price controls — those reductions result in less innovation abroad.

The Pharmaceutical Research and Manufacturers of America, which represents the major drug companies, said the two reports’ findings “substantiate that importation proposals represent a false promise to American consumers.”

Public Citizen, a D.C. watchdog group, released its own report Tuesday calling into question the government findings.

“Seven of 13 members of the Drug Importation Task Force are Bush political appointees, not career employees,” the group noted. “Moreover, the administration included no independent outside experts on the task force.”

Ron Pollack, executive director of Families USA, a nonpartisan group that advocates for affordable health care, said, “Rather than taking a year and spending taxpayer dollars to write a report that simply repeats the pharmaceutical industry’s arguments against reimportation, the administration should have focused on developing a system to provide Americans with access to affordable prescription drugs.”

Material from the Los Angeles Times and The Associated Press is included.