Importing Drugs a Reality in U.S.

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Importing Drugs a Reality in U.S.

By Mark Sherman, the Associated Press

March 19, 2004

A government panel exploring whether prescription drugs can be safely imported got a clear answer Friday from consumer advocates who said Americans already are doing it to cope with skyrocketing drug bills.

"It's a reality now because the United States government has failed to develop a model that assures drugs are affordable to Americans," Gail Shearer of Consumers Union said at the panel's first meeting at Food and Drug Administration headquarters in suburban Maryland.

Laurie Young of the Older Women's League said her members are angry about FDA's "refusal to make what is a common practice legal."

The new Medicare prescription drug law mandated that the Bush administration give Congress a report by Dec. 1 on whether and how drugs could be safely imported. Some lawmakers have called for the report sooner, and Health and Human Services Secretary Tommy Thompson has said it could be done by the summer.

Future hearings will include health care providers and pharmaceutical company representatives, who oppose legalizing drug imports.

The 11 administration officials said little about their own views on drug imports, although one of them, Mark McClellan, has been the administration's leading opponent of allowing prescription drugs from abroad. McClellan, the FDA commissioner, is about to take over the federal agency that runs the Medicare program.

Surgeon General Richard Carmona, the panel's chairman, said the issues surrounding drug imports are complex. "We start with many more questions than answers. We start with many more beliefs about what is possible than facts," Carmona said.

But many advocates said the government could safely remove legal barriers to importation without compromising safety. "This problem is not rocket science," said Dianne Sterenbuch of the National Alliance for the Mentally Ill.

Several pointed to legislation that passed the House last year that would allow importing FDA-approved drugs from FDA-approved facilities in Canada , the European Union and seven other nations. The measure also would require imported medicine to be shipped in anti-tampering and anti-counterfeiting packaging.

The administration opposed the House bill last year. Similar legislation is pending in the Senate.

There was also a widely held view that drug imports were themselves just a temporary solution to the problem of high drug costs.

"We can't go to any part of the country where we don't hear people complaining about the high cost of drugs," AARP's David Certner said. AARP provided crucial support for the Medicare legislation last year, but has been campaigning for changes to it, including allowing imported drugs and giving Medicare the authority to negotiate directly with pharmaceutical companies.

Some consumer groups urged caution on opening U.S. borders to drug imports, saying counterfeiting would inevitably worsen and drug companies would have less incentive to develop new products.

"Is the cure - drug importation - worse than the disease - high prices?" said Frances Smith of Consumer Alert.