Wednesday, March 7, 2007

The Bush administration yesterday favored keeping the ban on importing prescription drugs despite a new Democratic majority in Congress that supports allowing lower-priced medications from countries such as Canada.

The Senate Commerce, Science and Transportation Committee yesterday debated legislation introduced by Sen. Byron L. Dorgan, North Dakota Democrat, that would establish safeguards designed to ensure prescription drugs brought into the United States from Canada are not harmful. For instance, the bill directs the Food and Drug Administration to inspect Canadian drug exporters 12 times a year, far more frequently than U.S. drug makers.

“I think it’s wrong that consumers in the U.S. are forced to pay 98 percent more than Canadians for the very same medication,” Mr. Dorgan said. “My goal is not to force Americans to go to Canada to purchase their drugs but rather to create a little competition in the market so that we can put real downward pressure on domestic drug prices.”

Brand-name prescription drugs are significantly cheaper in Canada, which has led to a dramatic rise in the number of drugs being brought into the United States from Canada. Generic drugs are often affordable enough to purchase in the United States.

The senior citizens lobby AARP reported this week that the price of brand-name prescription drugs increased 6.2 percent last year, almost double the general inflation rate of 3.2 percent in 2006. The price for the popular sleep-aid drug Ambien jumped 29.7 percent, the group said.

However, the top drug lobby, the Pharmaceutical Research and Manufacturers of America (PhRMA), disputes AARP’s data and says prescription-drug prices increased 1.5 percent in 2006.

The administration’s position on importing prescription drugs is that it is unsafe. But under questioning from committee members, Randall Lutter, acting deputy commissioner for policy at FDA, said the agency would be overwhelmed with the additional responsibility of approving foreign-made drugs.

“The commercial importation of foreign versions of drugs would mean a substantial new FDA program,” Mr. Lutter said.

Mr. Dorgan’s legislation would create a program similar to the process the agency uses to approve generic drugs, he said. “We have 200 employees trying to approve 500 generic-drug applications annually. It would be a very significant expansion.”

Mr. Lutter said the FDA currently cannot ensure the safety of imported drugs because they do not fall under the agency’s oversight, and he highlighted the ongoing problem of counterfeit drugs sold over the Internet. The Internet has created an unregulated marketplace for the sale of unapproved prescription drugs, often marketed with fraudulent health claims.

Last month, the FDA issued an alert to consumers who placed orders on the Internet for Ambien, Xanax, Lexapro and Ativan but instead received products that contained haloperidol, a powerful anti-psychotic drug. Several people were treated in emergency rooms as a result of taking haloperidol.

“We have no way of tracking the Web sites that sell these unapproved drugs, and we can’t stop the drugs at the border with the resources we have,” Mr. Lutter said. In 2004, estimates showed that 10 million packages arrive in the United States from abroad containing 25 million types of drugs, Mr. Lutter said. Neither the FDA nor U.S. Customs and Border Protection tracks the amount of illegal prescription drugs entering the United States.

Billy Tauzin, president of PhRMA, raised the question of whether Canada and Europe would want to allow the United States to import prescription drugs. Because prescription-drug prices in Canada and Europe are controlled by their governments, opening their markets to the United States would drive up prices while lowering drug costs domestically.

Bernard Etzinger, spokesman for the Canadian Embassy, said currently there is no evidence of drug-price increases for Canadians as a result of selling their drugs to U.S. citizens.

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