FDA Finds Problems at FluMist Factory
Wednesday, May 30, 2007
The Food and Drug Administration said yesterday that its investigators found contamination problems with the manufacturing process of MedImmune's nasal flu vaccine FluMist but that the finished product was not affected.
The FDA's findings, detailed in a lengthy warning letter to MedImmune, will apparently not preclude the Gaithersburg company from producing vaccine for the upcoming flu season. But the agency's decision whether to approve FluMist to children under 5 is on hold until MedImmune begins correcting the problems.
MedImmune said Friday that there were compliance problems at its plant in Liverpool, England, but didn't disclose what they were.
After contamination in Chiron's British plant in 2004 forced the facility to shut down, the FDA began yearly inspections of flu vaccine manufacturers that sell products in the United States.
FDA officials identified manufacturing problems at MedImmune's plants in 2006 and discussed them with the company. When the FDA inspected the plant again in March, the agency said, "some of these issues had not been adequately addressed by the firm and had continued." MedImmune's response to the FDA's repeated concerns was inadequate, the agency said.
The FDA's letter cited "significant deviations from current good manufacturing practice." Agency officials took issue with MedImmune's investigations of instances when levels of mold and bacteria exceeded appropriate limits early in the production process.
FDA officials noted that while the product had not been contaminated, not fixing the problems increased the risk of product failures.
The letter also criticized the plant's cleanliness and said some employees there did not take necessary steps to prevent contamination.
MedImmune spokeswoman Jamie Lacey said the company was already talking with FDA officials to address their concerns as efficiently as possible.
FDA officials could not say when the agency might be able to act on MedImmune's application to market FluMist for children under 5. The FDA said it can approve the application only when the compliance status of the product up for approval is acceptable.
Expanding the product's market to children under 5 has been a cornerstone of MedImmune's efforts to revive FluMist, which has failed to catch on in the marketplace. It is now approved only for people ages 5 to 49.
Separately yesterday, MedImmune disclosed that a shareholder suing the company in an effort to block sale of the company to British pharmaceutical firm AstraZeneca has amended his complaint and has filed a motion in a Maryland state court for a temporary restraining order to prevent the $15.6 billion deal from closing until June 15. MedImmune said that another shareholder had also sued in opposition to the sale.
MedImmune said the lawsuits are without merit.