FDA frets Ill. drug import plan may use developing countries
Tuesday, August 24, 2004
WASHINGTON -- Illinois Gov. Rod Blagojevich's ambitious plan to help state residents buy less expensive prescription drugs from the United Kingdom also may permit drug imports from Europe's developing nations, the Food and Drug Administration fears.
But a Blagojevich spokeswoman said that the 84-page report Illinois submitted to the federal agency explains the safeguards the state would follow in procuring drugs only from FDA-inspected facilities and packaged for distribution in Canada, the United Kingdom or Ireland.
William Hubbard, the FDA's associate commissioner, said the Illinois plan still "lacked specificity" on key areas.
For instance, opening America's door to prescription drugs from the United Kingdom leaves it propped open for sketchier drug imports from lesser developed countries, he said.
"They don't have the kind of sophisticated regulatory system the U.K. has," Hubbard said Monday. With very little effort Latvia and Estonia, for example, could turn into gateways through which drugs pass, he said.
"These are not trivial issues. We understand the ramifications of this stuff," he said. "It's easy to say how great it is to go get British drugs."
But Abby Ottenhoff, a spokeswoman for the Democratic governor, said such concerns aren't even an issue in the Illinois plan. The drugs planned for importation are all FDA-approved, which means they are made at manufacturing plants the FDA already inspects.
The drugs that are shipped to Illinois must be packaged and labeled in English for distribution in one of the three English-speaking countries in the network.
"A drug intended for another country cannot be dispensed to an Illinois consumer under our program," Ottenhoff said. "For Mr. Hubbard to say we don't know where it's coming from is untrue. We do know. We know it's coming directly from the manufacturer to the country that is part of our network."
Hubbard that he plans to dispatch a letter to Illinois to get more details of safeguards, including how the state plans to limit European imports to drugs made in the United Kingdom.
Ottenhoff said it's all spelled out in the report, but that the administration would welcome Hubbard's inquiries. She noted that the plan also calls for Illinois inspectors to ensure the safety of drugs as they pass through wholesalers and pharmacies.
The drug regulatory agency has come under fire with critics in Congress and a growing number of state and local governments seeking to trim prescription drug costs by snagging cheaper Canadian imports.
Springfield, Mass., and the state of Vermont made formal drug importation requests to the agency. Vermont sued when its request was denied. Illinois, Minnesota, New Hampshire, North Dakota and Wisconsin made informal inquiries to the FDA. And a number of other interested parties are on deck, tailoring their actions to the agency's regulatory zeal.
On Monday, Rx Depot added its voice to the growing chorus of dissent. The Tulsa, Okla.-based company also had helped consumers buy Canadian drugs, but wondered why it was the subject of an FDA-driven lawsuit. Defiant states, like Illinois, merely received letters from the FDA.
"It is possible we will have to go to court against a state, at some point. We've not given any states a pass," Hubbard said. "We have told them they are at risk of violating the law. It could come down to a lawsuit."
Associated Press Writer John O'Connor in Springfield contributed to this report.
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