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Deadline missed for report on drug imports

Administration must examine safety of practice

WASHINGTON -- The Bush administration missed a deadline yesterday to give Congress a report on prescription drug imports, a day after it finalized a deal to buy flu vaccine made in Germany.

The report, required by last year's Medicare prescription drug law, is supposed to examine whether medicines can safely be brought into this country from Canada, where brand-name drugs cost at least a third less, and elsewhere.

Health and Human Services Secretary Tommy Thompson said there was no effort to delay the report to avoid any embarrassing link with the government's decision that it could safely import flu vaccine from Germany.

Fluarix, the German-made vaccine, has not been licensed by the Food and Drug Administration for use in the United States and so will be available only as an investigational new drug. That means it can be used, but every patient must sign a consent form acknowledging the possibility of risks.

But Thompson said the vaccine ''received the same kind of inspection as if it had been licensed in the United States. That's completely different from just having individuals purchase drugs from a foreign country that have not been inspected by FDA."

Thompson said he expected to receive the report yesterday from a government panel that he established earlier this year. But he said he would not make it public until he returns next week from an official trip to Europe.

Despite broad public support to legalize drug imports, President Bush and Republican congressional leaders were able to keep the issue from coming to a final vote in Congress, in part by saying they were awaiting the study.

In other matters, Thompson said he would separate the initial approval of prescription medicines from the ongoing monitoring of drugs after they are on the market, responding to a recent spate of criticism that the FDA does a poor job reviewing drug safety.

The agency currently handles both functions, and Thompson said he was unsure at this point of the new structure. ''But there's going to be some separation from the way it is right now," he said.

The administration also announced, on the anniversary of the Medicare law's signing, that it has chosen private companies in nine regions to start up pilot programs to coordinate care among 150,000 to 300,000 Medicare beneficiaries with chronic illnesses.

These patients use up most health care dollars. The companies that coordinate patient care must show at least a 5 percent drop in the cost of health care claims or risk not getting paid.

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