As a presidential candidate, Barack Obama said that the United States should be able to import prescription drugs (PDF) from other countries, where they are sold at significantly cheaper prices. He even co-sponsored a Senate bill proposing such an idea.
Now, however, his administration is warning against this idea. And a divide among Democrats on the issue is holding up the health care debate in the Senate.
Sen. Byron Dorgan (D-N.D., at left) on Tuesday introduced an amendment to the Senate health care bill that would enable the importation of cheaper prescription drugs into the U.S. The plan, Dorgan says, would save the federal government $19 billion over 10 years and save the American people about four times that much.
Nineteen other senators, including four Republicans, immediately offered their support to the plan.
Dorgan expected a vote on the amendment as early as Wednesday afternoon, but by Thursday Sen. Majority Leader Harry Reid (D-Nev.) temporarily halted the entire health care debate, having not made progress on the amendment.
On Wednesday, Food and Drug Administration commissioner Margaret Hamburg sent a letter arguing that the importation of FDA-approved drugs from countries like Canada could endanger the U.S. medicine supply. She also said it would be difficult to implement.
"I was surprised by the letter by the FDA because the day before I had talked to the administrator of the FDA, and she was unaware of any letter," Dorgan said in a conference call with reporters Wednesday morning. "We've become accustomed over the years to this sort of thing, in the 12th hour receiving a letter from the FDA."
(In fact, the Hill newspaper reports, FDA commissioners during both the George W. Bush and Clinton administrations issued similar warnings about drug re-importation proposals.)
Dorgan insisted to reporters that there is nothing dangerous about his plan. He said it actually contains a number of safety provisions, including establishing batch lots and tracers, that do not yet exist for our domestic supply of pharmaceuticals. David Kessler, who served as FDA commissioner from 1990 through 1997, has endorsed Dorgan's amendment, the senator told reporters.
"There's no safety issue here at all," Dorgan said. "This is the pharmaceutical industry trying in every way that it knows how to keep its ability to charge the highest prices in the world for prescription drugs to the American people."
Drug wholesalers purchase pharmaceuticals from drug manufacturers at higher prices in the United States because, unlike in many other countries, the government does not negotiate a set rate for drug prices.
Under Dorgan's plan, U.S. wholesalers would buy drugs from wholesalers in countries like Canada. The drugs would in all likelihood still be more expensive than if the United States were to directly negotiate with the pharmaceutical industry, but it would at least result in cheaper prices than Americans currently pay.
"How about giving the American people the freedom that others have to access those prescription drugs -- FDA approved drugs -- that are sold at a fraction of the price in other countries," Dorgan said. "And it'll force the pharmaceutical industry to re-price those drugs in this country."
The savings the federal government and American consumers would potentially achieve, however, would come at the drug industry's expense. And "industry support is considered a key to passage" of the overall health care bill, the Los Angeles Times reports.
The White House negotiated a deal with the drug industry earlier this year that limited the industry's contribution to reform to $80 billion. "The drug-import amendment was not part of that negotiation, but it was widely believed that the industry would oppose the bill if such an amendment were included," the Times reports.
The White House said in a statement that Mr. Obama still supports drug importation but is concerned about safety issues.
"The president supports reimportation of safe and effective drugs," White House spokeswoman Linda Douglass said in a statement. "The Food and Drug Administration has raised safety concerns about the current proposal and will continue exploring policy options to create a pathway to importing safe and effective drugs."
Meanwhile, Democrats from states with major drug companies have come out strongly against the amendment.