Citing "an urgent need" at a time of flu vaccine shortages, Illinois asked for federal permission Monday to buy at least 62,000 vaccine doses from Europe for the state's nursing home residents.
A letter outlining the proposal was sent to the Food and Drug Administration, which Gov. Rod Blagojevich (D) has been battling over his push to import lower-priced prescription drugs from Canada.
"I have every reason to think the FDA will work with us on this," Blagojevich said.
The acting FDA commissioner, Lester M. Crawford, said the agency would evaluate the state's request "expeditiously."
The U.S. supply of flu vaccine was slashed nearly in half when British manufacturer Chiron Corp. was barred from shipping any of its vaccines because of contamination in its plant at Liverpool, England.
Blagojevich wants the FDA to inspect a manufacturing facility in France that makes the Aventis Pasteur flu vaccine for distribution in Canada and Europe. The FDA would have to test the vaccine before it could be approved, officials said. Aventis is the country's other major supplier.
"With regard to any new sources identified, we would make sure the vaccine is safe and effective and add it to the amounts we are negotiating for from other countries," Crawford said.
The FDA did not indicate how soon it might make a decision on the Illinois request.
Illinois officials have not clinically tested the Aventis Pasteur vaccine on U.S. flu patients, but they reviewed the literature and determined its properties are identical to those of the vaccine used in the United States, said Jonathan Dopkeen, assistant director of the Illinois Department of Public Health.
The FDA and the Department of Health and Human Services have been working with pharmaceutical companies in other countries to try to find more flu vaccines, said Bruce Gellin, director of the National Vaccine Program Office.
The vaccine Blagojevich wants to buy would have to be examined closely because it would come from a British wholesaler instead of the drug company and it might not be effective, Gellin said.
"You've got an added risk when you're dealing with wholesalers," Gellin said. For one thing, he said, vaccines must be stored properly to ensure their effectiveness.
Blagojevich said state officials had negotiated a tentative deal to buy the Aventis flu vaccine for $7 a dose, well below the U.S. price.
Last year, Illinois requested federal approval to set up a pilot program for the state to import drugs from Canada for state employees and retirees, but the FDA refused to approve the plan, arguing it cannot vouch for the safety of imported drugs.
Blagojevich then created the I-SaveRx program, which helps Illinois residents buy lower-priced prescription drugs from pharmacies in Great Britain and Canada. It was through that program, which prompted complaints from the FDA, that the state developed a relationship with the vaccine wholesalers, said the governor's spokeswoman, Abby Ottenhoff.
Also Monday, New Jersey lawmakers approved a measure that would allow $500 fines for medical personnel who give vaccinations to people not considered at high risk for complications from the flu. A spokesman for Gov. James E. McGreevey (D) said he was reviewing the bill.