- The Washington Times - Monday, October 20, 2003

The head of the Food and Drug Administration last night criticized a measure in Congress that would lift the ban on importing prescription medicine from Canada and other countries.

Foreign drugs may be more affordable, but it would be too risky to allow consumers to buy medicine that does not meet U.S. safety standards, FDA Commissioner Mark B. McClellan said.

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“People’s health is put at risk when doctors and pharmacists … are replaced by storefronts and bogus Internet sites that are there for private profit, not public health,” according to prepared remarks Mr. McClellan was scheduled to deliver in a speech to the National Press Club last night.

“Until we find solutions that do not force Americans to make choices between safety and affordability, all of us involved in policy cannot rest.”

It is illegal to purchase medicine outside the United States, although the federal government rarely prosecutes violators. Each year, about 2 million Americans drive across the Canadian border or shop online for medications that can cost as much as 75 percent less, according to published reports.

Mr. McClellan’s speech marked his harshest criticism to date of provisions in the House and Senate Medicare drug-benefit bills that would permit consumers to buy drugs legally in countries such as Canada.

As part of its Medicare overhaul bill this past summer, the Senate approved legislation that would allow reimportation of drugs, but only after the Department of Health and Human Services certifies it is safe — something Secretary Tommy G. Thompson has said he could not see doing.

The House, though, passed a broader version that does not give the secretary discretion. The Bush administration is adamantly opposed to that version, which a spokesman called “dangerous legislation.”

House and Senate negotiators working out the differences in the Medicare bills are expected to discuss the reimportation provisions this week.

In September, Mr. McClellan told AARP, the nation’s largest lobby for older Americans, that he did not rule out easing restrictions on buying prescription drugs from other countries, as long as strong protections against contaminated or counterfeit drugs were put in place.

AARP has endorsed the reimportation of drugs from Canada only if concerns about the safety of the medicine are addressed.

The Democratic presidential candidates also have backed drug importation.

U.S. pharmaceutical companies oppose drug importation. Executives say adapting foreign price controls will result in less money for research and development of new medicine.

Stephen Dinan contributed to this report.

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