A Senate push to allow wide-scale importation of lower-priced prescription drugs from Canada and other countries yesterday sidetracked a Senate plan to pass major drug safety legislation.

Senate leaders put off final votes on the drug safety measure until next week after Sen. Byron Dorgan, a Democrat from North Dakota, won a procedural vote allowing him to move ahead with the reimportation provision. Concerned that reimportation could jeopardize the eventual enactment of a new drug safety law, key lawmakers worked behind-the scenes to reach a compromise but no reported no progress.

The White House opposes reimportation, saying its inclusion would cause President Bush to the veto the bill because of concern it would result in “unsafe, unapproved and counterfeit drugs” into the US. Allowing lower cost imports also is opposed by drugmakers, which worry about profits and argue the move could leave the nation vulnerable to unsafe medicines.

But Dorgan and other proponents insist drugs can be imported safely under FDA supervision, ensuring lower costs for Americans. “The fact is, we are paying the highest prices for brand-name prescription drugs in the world and that’s not fair,” he says. “We ought to change that.”

The 63-28 vote allowing Dorgan to move forward with his amendment indicated strong support for his plan. A 2004 Congressional Budget Office found that allowing drug imports could cut drug spending by $40 billion over 10 years.

Opponents are hoping to add a requirement that the FDA first certify that imported medicines are safe and effective. Federal health officials since the Clinton administration have refused to make such a certification.

Wyoming’s Mike Enzi, a Republican and key sponsor of the safety bill, warned that Dorgan’s amendment “will throw open our borders to drugs that have much higher risks. We’ve come too far and made too much progress in reaching a bipartisan drug safety bill to allow his dangerous loophole in at the last minute. We want all affordable drugs. But a counterfeit or tainted drug is unsafe at any price.”

Posted by Robert Cohen of The Star-Ledger of New Jersey[tags]Counterfeit, PDUFA, Reimportation[/tags]