U.S. senators vowed on Wednesday to move forward with legislation to legalize the importation of cheaper prescription drugs from certain countries, despite resistance from regulators and drugmakers.
One Democrat and three Republicans said their plan would provide money and safeguards for the Food and Drug Administration to assure the imports were not dangerous.
"I believe this legislation puts in place an effective regulatory framework to make importation of FDA-approved drugs safe for consumers," Sen. Byron Dorgan (news, bio, voting record), a North Dakota Democrat, said at a hearing.
Dorgan said the goal was to "create a little competition in the marketplace so we can put a real downward pressure on prescription drug prices."
The legislation would allow consumers, pharmacies and wholesalers to purchase FDA-approved medicines sold in Canada and other industrialized countries. Congress would provide money so the FDA could make sure the medicines and manufacturing sites met agency standards, supporters said.
One-third of senators already have backed the bill, said Dorgan, who chairs a subcommittee of the Senate Commerce, Science and Transportation Committee.
Many Americans already have bought medicines from abroad, often through Internet pharmacies, even though the practice is illegal.
The FDA has warned against congressional efforts to legalize importation, arguing the agency cannot vouch for drugs purchased from foreign sources.
Randall Lutter, acting deputy FDA commissioner for policy, said the agency remained "immensely concerned about unapproved, imported pharmaceuticals whose safety and effectiveness cannot be assured."
Importation backers told Lutter they were skeptical the FDA could not find ways to certify imported drugs when the agency allows a wide range of foods into the country.
"I don't understand at all why FDA, given the resources ... cannot do what others in the world can do," Dorgan said.
Republicans echoed Dorgan's view.
"It is doable, it is reasonable and I think, frankly, the time has come," said Maine Sen. Olympia Snowe (news, bio, voting record).
Lutter said the FDA would need to verify drugs bought overseas were safe, effective and equivalent those sold in the United States. That would require "a major expansion" of the agency's duties, he said.
Billy Tauzin, head of the Pharmaceutical Research and Manufacturers and America, said legalizing widespread importation would increase the chances of counterfeit drugs being sold to Americans.
"I just want to warn you ... one day we will rue the day we opened up that door," he said.
Copyright © 2007 Reuters