Head of FDA pressed to ease drug imports

Friday, March 12, 2004

By BART JANSEN, Portland Press Herald Writer

WASHINGTON — Members of a Senate committee urged the head of the Food and Drug Administration Thursday to ease the importation of prescription drugs from Canada. Mark McClellan maintained that protecting public health would make such an effort costly and complicated.

McClellan previously refused to testify at the Commerce Committee, where members, including Sen. Olympia Snowe, R-Maine, have sought to open the door to medications that cost half as much in Canada as in the United States. Because McClellan has been nominated to become head of the Centers for Medicaid and Medicare Services, senators threatened to hold up a Senate vote until he appeared.

The political storm worsened Wednesday, when Health and Human Services Secretary Tommy Thompson withdrew McClellan's designation as chairman of a task force that will study importation over the next year.

On Thursday, Snowe led others in urging McClellan to work with lawmakers to allow imports rather than remain one of the fiercest opponents in the administration. She suggested that legislation could be drafted so that the FDA would rely on wholesalers to import drugs safely, because they must meet with suppliers face-to-face and they must ensure that drugs aren't altered.

"We need to know what we can do to make it safe," Snowe said. "Why isn't that possible here and now?"

McClellan agreed to work with lawmakers on technical aspects of any legislation. But he said repeatedly that changing existing law, which guarantees safety, is difficult and that screening drugs from Canada would be costly. He estimated it would cost hundreds of millions of dollars to certify drugs from Canada alone, depending on how many types were allowed.

Importation is important in Maine because the elderly and uninsured routinely cross the border for government-capped prices in Canada. Individuals report saving thousands of dollars on six-month supplies of medication.

"We're not talking about an academic situation," said Sen. John McCain, R-Ariz. and committee chairman. "We're talking about seniors going to bed tonight making a decision about whether to buy their prescription drugs or to eat."

Congress has approved importation from numerous countries several times - so long as the Department of Health and Human Services certifies that the drugs are safe. Health secretaries in the Clinton and Bush administrations refused to offer such a guarantee because they couldn't track the drugs from the manufacturer to the customer's hands, as they do in the United States.

Drug makers represented by Pharmaceutical Research and Manufacturers of America contend that imports might be unsafe. They also contend that curbing profits would deter research on cutting-edge medication.

McClellan said that during a three-day blitz of airport shipments in November, inspectors found that 2,256 packages of drugs violated the law, out of 3,375, for including recalled drugs, bad labels, lack of proper storage conditions, or controlled substances such as codeine and valium.

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