FDA Letter Addresses Flu Vaccine Contamination
Sanofi Pasteur received a warning letter from FDA regarding quality-control problems at the company's influenza vaccine manufacturing facility in Pennsylvania, the San Francisco Chronicle reports. Sanofi, which plans to produce 50 million doses of vaccine for the U.S. market this year, notified FDA on March 31 that "sterility failures" had been detected in 11 batches of vaccine in early stages of the manufacturing process.
Sanofi scientists think the batches were contaminated by a filtration device failure, which has been fixed, according to David Johnson, Sanofi's plant director of scientific and medical affairs (Russell, San Francisco Chronicle, 7/4).
FDA in April conducted a "comprehensive" 10-day inspection of the facility and "determined that some of [Sanofi's] corrective actions were not appropriate," according to Mary Malarky, director of compliance and biologic quality at the agency.
David Elder, enforcement director for FDA, in the June 20 warning letter said, "Failure to promptly correct these deviations may result in FDA initiating regulatory action. ... Such action may include license suspension and/or revocation, seizure and/or injunction."
Sanofi has 15 working days to submit in writing its plan for correcting the problems (Rubin, USA Today, 7/5).
Karen Midthun, deputy director of FDA's Center for Biologics Evaluation and Research, said, "The fact that no further sterility failures have occurred since early April is a good sign. However, the fact that no root cause for the failures has been identified to date means that we can't know for sure whether the problem has been corrected."
The manufacturing plant will be allowed to remain open while Sanofi takes corrective action (MacPherson/Silverman, Newark Star-Ledger, 7/4).
An entry on FDA's Web site says the manufacturing problems "are not expected to significantly affect the availability of Fluzone for the 2006-2007 flu season, but we continue to review the progress made by the company" (USA Today, 7/5).
Sanofi in a statement said it is taking the warning letter "very seriously." Sanofi said, "Actions have been underway to address the agency's findings since the inspection, and we have been reporting our progress weekly during communications with the FDA. We are confident we will meet our manufacturing of approximately 50 million doses of influenza vaccine for the U.S. market" (Whalen, Wall Street Journal, 7/4).
Gordon Richman, a compliance consultant to drug companies and former director of worldwide quality strategy at GlaxoSmithKline, said, "FDA is being very responsible to this because of the past history of the flu vaccine. They've identified some very significant issues with regard to the company's quality system" (USA Today, 7/5).
Greg Poland, a professor of medicine and director of the vaccine research group at the Mayo Clinic, said, "The big lesson here is that we've got to move away from [chicken] egg-based manufacturing. That's 1940s and 1950s technology, and it's extremely difficult to prevent contamination" (Newark Star-Ledger, 7/4).
Sarah Sellers, a drug safety consultant, said, "There are many, many potential sources of contamination. It's just very, very messy. I think the take-home message ... is we need new technology. We should have had it a decade ago" (USA Today, 7/5).