Monday, May 07, 2007

Senate Likely to Back Drug Reimportation
Senate Likely to Back Drug Reimportation
Arguments Pit Savings Against Safety
By Christopher Lee
Washington Post Staff Writer

The Senate cleared the way yesterday for the likely adoption of a measure that would legalize the reimportation of lower-cost prescription drugs from Canada and other countries, a move supporters say would save consumers $50 billion over 10 years.

Ignoring a White House veto threat, lawmakers voted 63 to 28 to move to a final vote on adding the drug provision to a larger bill on the operations of the Food and Drug Administration.

"There is a pricing problem with prescription drugs," said Sen. Byron L. Dorgan (D-N.D.), who co-sponsored the amendment with Sen. Olympia J. Snowe (R-Maine). "The identical drug, FDA-approved, the same pill, put in the same bottle, made by the same company, is set virtually every other place in the world at a lower price. And the American consumer is told, 'You know what, we have a special deal for you: You get to pay the highest price in the world.' "

Sen. Mike Enzi (R-Wyo.), one of the lead sponsors of the FDA bill, opposed the amendment, saying the FDA has enough trouble determining whether domestic drugs are safe.

"I'm baffled that we want to take on all the hard work and effort to fix our drug system's problems and then throw it all away opening it up to more drugs," Enzi said. "Let's get it fixed at home before we open it up to the world."

A final vote on the provision, as well as one on the larger bill, is not expected until next week. The House has not yet taken up similar FDA legislation.

The provision would allow consumers to buy prescription drugs from Canada and permit commercial distributors to obtain them from Canada, Japan, Austria, Switzerland and other European Union nations, Dorgan's staff said. Imported drugs would have to be FDA-approved, manufactured in facilities inspected by the FDA and carry documentation about the chain of custody of the drugs.

Earlier this week, the White House said President Bush's advisers would recommend that he veto any reimportation provision that did not address safety concerns around imported drugs that were identified by a Department of Health and Human Services task force in 2004.

"The administration believes that allowing the importation of drugs outside the current safety system established by the FDA without addressing these serious safety concerns would threaten public health and result in unsafe, unapproved and counterfeit drugs being imported into the United States," the White House statement said.

Despite support in the House and Senate, the White House for years has blocked legislation opening the borders to the reimportation of U.S.-made pharmaceuticals, arguing that their safety cannot be assured. During the Clinton administration, Health and Human Services Secretary Donna E. Shalala similarly concluded that she could not guarantee a safe system for drug imports.

Sen. Thad Cochran (R-Miss.) has offered a further amendment that would require the federal government to certify the safety of imported drugs and determine whether importation brings any economic benefit. If the Bush administration reported an inability to certify the safety of the drugs, Dorgan and Snowe's amendment could be undercut.