Drug Imports allowed from Canada

For more than two decades, Congress has been wrestling with the question of whether to allow prescription drugs to be imported from countries such as Canada, where prices are far lower than in the United States.

This year, the answer may be yes.

"I expect us to be able to send a bill to the president," said Sen. Byron Dorgan, D-N.D. "We'll see what he does with it."

Dorgan and Sen. Olympia Snowe, R-Maine, are sponsoring a bill he said would "introduce a little price competition into the market by allowing the safe importation of FDA-approved medicines from Canada and other Western industrialized nations."

Efforts to bring a similar bill to the floor last year were foiled by Majority Leader Bill Frist, R-Tenn., a thoracic surgeon. Since then, Frist has left the Senate and the leader of the now-majority Democrats, Sen. Harry Reid of Nevada, supports the bill.

"Things have changed around here," Dorgan said. "We are going to get this done."

Pressure to change the 1987 law prohibiting the importation of drugs from Canada and other countries has been growing as prescription prices have escalated here. Most brand-name prescriptions sold in Canada and other countries that regulate drug prices cost far less than in the U.S.

The ban on imported drugs allows American drug companies to "dictate the prices U.S. consumers pay," Dorgan said.

His bill would achieve two main objectives:

* Allow drugs manufactured in the United States and sold to Canada and other Western industrialized countries to be reimported into the U.S. as long as the Food and Drug Administration approves the "chain of custody."

* Allow drugs manufactured and packaged in Canada and other approved countries to be imported directly to U.S. consumers if the manufacturing and shipping facilities are FDA-approved.

It is unclear whether Bush would veto the bill. The president has not commented on the current legislation, but the White House issued a policy statement in 2003 that said the administration "strongly" opposed a similar bill.

That statement called the measure "dangerous legislation" and warned it would "expose Americans to greater potential risk of harm from unsafe or ineffective drugs, would be extremely costly to implement, and would overwhelm (the FDA's) already heavily burdened regulatory system."

A Dorgan spokesman said he questioned whether Bush would veto the current bill because Bush said during the 2004 presidential debates that he would support drug reimportation from Canada if he was convinced it was safe.

The spokesman would not predict whether there would be enough votes in both chambers of Congress to override a veto. A two-thirds vote would be needed in both the House and Senate to override a veto.

But the bill does have strong bipartisan support.

When an FDA official testified last week before Dorgan's interstate commerce, trade and tourism subcommittee, some of the sharpest comments about the FDA's position came from the panel's Republican members.

"We're hearing ... bureaucratic intransigence about coming up with a way in which to allow this to happen," Snowe chided Randall Lutter, the FDA's acting deputy commissioner for policy. "Why isn't there the can-do spirit where it's a can't-do spirit?"

Sen. Jim DeMint, R-S.C., noted the FDA already inspects and regulates the food supply coming into the U.S. from foreign countries and said it was inconsistent for the agency to say it could not inspect the prescription drug supply.

Lutter cited a 2004 government task force report warning that allowing drugs to be imported would open the floodgates to counterfeit drugs manufactured or packaged without FDA inspection and approval.

But Dorgan called the task force's report "a joke" because the panel was filled with Bush administration members who were on record opposing reimportation.

William Schultz, an attorney who served in the same role as Lutter during the Clinton administration, said American consumers are already purchasing drugs from Canada and other foreign sources with no way of telling which suppliers are safe.

Billy Tauzin, a former Louisiana congressman who is now the chief executive officer for the Pharmaceutical Research and Manufacturers of America trade group, warned that European countries that allow the movement of prescription drugs from one country to another have seen a recent surge in counterfeit drugs, mostly from China.

Tauzin, a Republican, argued that the reimportation bill is not needed because the Medicare Part D prescription drug benefit has lowered the price paid by beneficiaries to less than they would pay for Canadian and other foreign drugs.

But Snowe noted that many Medicare beneficiaries are forced to pay full price for their drugs when they hit the "doughnut hole" - the gap in which Part D plans do not cover drug costs.