Sunday, May 9, 2010

FDA Knew Problems at Vaccine Plant Were Pervasive, Documents Show


Knight Ridder Newspapers

KANSAS CITY, Mo. - (KRT) - American regulators knew five years ago that contamination at the now-infamous vaccine plant in Liverpool, England, was both pervasive and persistent, documents show.

In fact, evidence was so overwhelming that regulators should have shut down the plant or sought alternative flu vaccine sources long ago, say some vaccine and pharmaceutical experts who have reviewed the documents.

Instead, the United States has lost 48 million doses of flu vaccine - half its supply - after British regulators found more contamination and suspended the plant's license last month.

Documents obtained by The Kansas City Star show the Food and Drug Administration five years ago noted that the plant, then owned by the British firm Medeva, had failed to correct longstanding problems. But the agency continued to allow the plant to supply the U.S. market despite clear departures from what the agency calls "Good Manufacturing Practices." Read more...

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