WASHINGTON -- The Senate, clearing the way for action on a major overhaul of the government's troubled drug safety system, has sidetracked a controversial amendment that would have let Americans buy medicines from foreign suppliers but threatened to stall action on the larger bill.
The drug import measure, which was tacked onto the FDA overhaul, could have saved consumers billions of dollars, its sponsors said.
But the pharmaceutical industry has argued that pharmacies risk being flooded with counterfeit drugs. And the White House, which also opposes importation, had threatened a veto of the drug safety bill if it eased restrictions.
That put the Senate's Democratic majority in a bind: Many favor direct drug importation, but the amendment threatened to stymie a reform of the Food and Drug Administration that is considered must-pass legislation..
So some Democrats straddled the issue yesterday by voting for the amendment but also for a proviso requiring the government to certify that imports are safe - a step the Bush administration is unlikely to take.
The 49-40 vote to approve the proviso, offered by Sen. Thad Cochran, a Mississippi Republican, was seen as a major victory for the pharmaceutical industry.
Maryland's Democratic senators split on the Cochran amendment. Sen. Barbara A. Mikulski voted for the measure; Sen. Benjamin L. Cardin voted against it. Sen. Michael B. Enzi, a Wyoming Republican, said the requirement for a safety certification was essential to protect the public.
Cochran's caveat "is clearly a poison pill," said Sen. Bernard Sanders, a Vermont Independent and a strong supporter of allowing imports.
"Today is a day of lost opportunity," said Sen. Byron I. Dorgan, author of the import proposal. If it became law, U.S. pharmacies would be allowed to import prescription drugs produced in FDA-licensed facilities in other developed countries.
The North Dakota Democrat accused the drug industry of wanting to dictate prices to American consumers. "Yes, we have price controls in America," Dorgan said. "Not government price controls, but price controls by the pharmaceutical industry."
The Senate went on to pass Dorgan's legislation by a voice vote - with Cochran's proviso added. In the past, even Democratic administrations have been reluctant to make sweeping declarations about the safety of imported medications.
"This fight is not over," Dorgan said. "We will be back." White House officials had already said they would withdraw the veto threat if the Senate included Cochran's requirement.
Cochran said the problem of counterfeit drugs was his main concern: "Americans deserve continued access to safe and effective drugs. Serious problems exist with products from other countries."
Drug industry representatives make the safety argument as well. But they also worry that opening the United States to imports of prescription drugs would eventually lead to government-set prices here. That's already the case in Canada and Europe.
The Senate is expected to finish work on the FDA drug safety bill this week.
Ricardo Alonso-Zaldivar writes for the Los Angeles Times.