FDA Relying On Pedigree Info To Authorize Use Of Imported Flu Vaccine
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA is relying on confirmed lot numbers and pedigree information to authorize the use of Sanofi-Aventis' Fluzone purchased directly from European distributors by state and local governments
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FDA is relying on confirmed lot numbers and pedigree information to authorize the use of Sanofi-Aventis' Fluzone purchased directly from European distributors by state and local governments. "We had to get the lot numbers of the vaccines off the vaccines still in Europe," FDA Acting Commissioner Lester Crawford said during a Dec. 7 teleconference. "We've checked those out with the company….They were legitimate." "The next thing we needed was a pedigree, that is, where has the vaccine been? Has it been refrigerated? Kept under conditions where it would be expected realistically to still be viable?" "We got that information just this week from the state of Illinois," Crawford said. "We are rapidly progressing through that, and by the end of the week we expect to have gotten through virtually all the information. Then we'll be ready to make some announcements about it." FDA has been examining the product documentation in response to concerns by state and local governments that hope to use the vaccine to alleviate a shortage of U.S.-approved vaccine. Evaluating lot numbers and pedigree information may represent one mechanism for certifying the safety of pharmaceuticals purchased directly from suppliers located outside of the U.S. FDA remains staunchly opposed to drug importation, arguing that it would be unable to certify the safety of drugs purchased from foreign suppliers. Illinois, New Mexico, New York City and Cleveland, Ohio are seeking to import 750,000 doses of the Aventis flu vaccine that they identified in European distribution channels (1 (Also see "Excess Foreign Flu Vaccine Supply Could Add 6 Mil. Doses To U.S." - Pink Sheet, 17 Nov, 2004.)). "New York City has indicated that they need 200,000 doses, and I believe the other states are somewhere in that particular range," Crawford said. According to Illinois Gov. Rod Blagojevich's (D) website, the state has secured between 142,000 and 167,000 doses from European suppliers; an additional 120,000 are expected to be available for purchase. The city of Cleveland has also expressed interest in purchasing flu vaccine from foreign suppliers. The city is still awaiting a response from FDA about purchasing doses directly from distributors in Canada. In the same teleconference, HHS Secretary Tommy Thompson announced the approval of use of GlaxoSmithKline's Fluarix in the U.S. under an investigational new drug application (see 2 (Also see "GSK Flu Vaccine To Be Available In U.S. With Informed Consent" - Pink Sheet, 7 Dec, 2004.)). - Andrew Shelton |