WASHINGTON -- The Illinois governor's ambitious plan to help that state's residents buy prescription drugs from Britain also may permit drug imports from Europe's developing nations, the Food and Drug Administration fears.
Governor Rod R. Blagojevich provided the FDA with an 84-page report spelling out how Illinois would act as a trusted intermediary, facilitating safe prescription drug purchases from Canada and Britain.
William Hubbard, the agency's associate commissioner, said the Illinois plan still "lacked specificity" on key areas.
For instance, opening America's door to prescription drugs from Britain 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 UK has," Hubbard said. With very little effort Latvia and Estonia, for example, could turn into gateways for drugs made in such countries as Turkistan.
"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."
Hubbard said yesterday 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 Britain.
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.
Yesterday, Rx Depot added its voice to the growing dissent. The company, based in Tulsa, Okla., 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."