The prescription bottle may say "Made in England," but the Food and Drug Administration worries that Illinois' plan to help residents buy drugs from the United Kingdom may also allow counterfeit drugs from other countries.
A spokeswoman for Illinois Gov. Rod Blagojevich said the plan has safeguards to ensure the imported drugs are legitimate.
Blagojevich gave the FDA an 84-page report spelling out how Illinois would act as an intermediary between patients and foreign suppliers. William Hubbard, the FDA's associate commissioner, said he will ask Illinois to provide missing details on key areas.
For instance, Hubbard said, opening America's door to prescription drugs from the United Kingdom leaves it propped open for sketchier drug imports from less-developed countries.
"They don't have the kind of sophisticated regulatory system the U.K. has," Hubbard said. Latvia and Estonia, for example, could turn into gateways for products made in other countries known for drug counterfeiting, he said.
Abby Ottenhoff, a spokeswoman for Blagojevich, dismissed such concerns. The drugs Illinois will import are all FDA-approved, which means they are made at manufacturing plants the agency already inspects, she said.
The drugs also must be packaged and labeled in English for distribution in the United Kingdom, Ireland or Canada, Ottenhoff said.
The FDA has come under fire from critics in Congress and a growing number of state and local governments seeking to trim prescription drug costs by using cheaper Canadian imports. A task force led by the surgeon general is preparing a report on drug importation.
Hubbard responded to the trend in an op-ed article published in Monday's edition of USA Today.
"At mail facilities around the country, we are identifying drugs arriving from unreliable sources in such places as the Bahamas and Pakistan," Hubbard wrote. He warned of "bad drugs shipped from Belize, but identified as Canadian; counterfeits from India shipped in Tupperware" and other suspicious medicines.
Springfield, Mass., and the state of Vermont have made formal drug importation requests to the FDA. Vermont sued when its request was denied. Illinois, Minnesota, New Hampshire, North Dakota and Wisconsin are among the states that have made informal inquiries to the FDA, and a number of other interested parties are on deck.
Rx Depot, based in Tulsa, Okla., has helped U.S. consumers buy Canadian drugs. The company has been sued by the FDA, but defiant states, such as Illinois, have merely received letters.
"Rx Depot is a small and easy target to knock off," said Fred Stoops, a lawyer representing the company. "The political ramifications of taking on the state of Illinois would be enormous."
Hubbard disagreed, saying the FDA has a long tradition of more aggressive pursuit of commercial enterprises. States, so far, have neither directly imported prescription drugs nor sought to turn a profit from their role in facilitating sales.
"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."
Ottenhoff said Illinois' proposal came after failed attempts to work cooperatively with the FDA. The state estimates sales of imported prescription drugs could save Illinois consumers up to $1.9 billion in just the first year.
"We've worked very hard to try to coordinate with the FDA, to try to set up a pilot program so that we, together, can figure out what mechanisms need to be in place to ensure importation can be done safely," Ottenhoff said. "They have shown no interest in working with us."
The FDA, by contrast, points to a four-page letter, sent on June 3 from Lester Crawford, the agency's acting commissioner, that asked Illinois for more details about its project. The recently passed Medicare modernization act allows for importation of prescription drugs from Canada, but only if consumers save money and are unharmed by the imported drugs.
The Act "does not authorize any specific waivers, state pilot programs, experiments or other temporary or short-term programs for importing unapproved drugs," Crawford wrote. "In essence, the (Health and Human Services) Secretary must certify that unapproved drugs can or cannot be safely imported for all Americans, not just those people in one state or region of the country."