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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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MedImmune Vaccines, Inc. 21-Jun-05

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Center for Biologics Evaluation and Research
1401 Rockville Pike
Rockville MD 20852-1448


 


June 21, 2005


CBER-05-022

VIA FACSIMILE AND CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

Kimber L. Poffenberger, Ph. D.
MedImmune Vaccines, Inc.
One MedImmune Way
Gaithersburg, MD 20878

Re: BLA STN #125020
FluMist® (Influenza Virus Vaccine Live, Intranasal)

Dear Dr. Poffenberger:

The Office of Compliance and Biologics Quality (OCBQ) in the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) has reviewed the Vaccine Assessment Tool Flyer (copy enclosed) for FluMist® (Influenza Virus Vaccine Live, Intranasal) submitted under cover of Form FDA 2253. This consumer-directed flyer is misleading because it fails to reveal material facts regarding the risks associated with the use of FluMist and, therefore, violates section 502(a) of the Federal Food, Drug, and Cosmetic Act (the Act). 21 U.S.C. 352(a). Your flyer was also apparently disseminated without adequate directions for use, in violation of section 502(f) of the Act. By failing to include sufficient information on risks and adequate directions for use, you have encouraged the potentially unsafe use of FluMist.

Background

According to the FDA-approved professional labeling (PI), FluMist is a live trivalent nasally administered vaccine intended for active immunization for the prevention of influenza. The PI states:

"FluMist is indicated for active immunization for the prevention of disease caused by influenza A and B viruses in healthy children and adolescents, 5-17 years of age, and healthy adults, 18-49 years of age. FIuMist is not indicated for immunization of individuals less than 5 years of age, or 50 years of age and older, or for therapy of influenza, nor will it protect against infections and illness caused by infectious agents other than influenza A or B viruses."

The PI also includes the following detailed risk information including contraindications, warnings, precautions, and adverse reactions:

  • FluMist is contraindicated in individuals with a history of hypersensitivity to any component of the vaccine, including eggs or egg products; in children and adolescents receiving aspirin therapy or aspirin-containing therapy; in individuals with a history of Guillain-Barre syndrome; and in individuals with known or suspected immune deficiency.

  • The safety of FluMist has not been established in pregnant women or for patients with chronic underlying medical conditions, including asthma or reactive airways disease; the vaccine should not be administered to these patients.

  • Adverse events include runny nose/nasal congestion, cough, irritability, headache, sore throat, decreased activity, and muscle aches.

The flyer promotes the indication for FluMist, "for active immunization for the prevention of disease caused by influenza A and B viruses in healthy children and adolescents, 5 to 17 years of age, and healthy adults, 19-49 years of age"

Failure to Reveal Material Facts

The flyer fails to provide appropriate risk information. It only states, "There are risks associated with all vaccines, including FluMist. Like any vaccine, FluMist does not protect 100% of individuals vaccinated." More specific information is necessary to qualify the effectiveness claim appearing on this material. This omission of such risk information results in your product being misbranded within the meaning of section 502(a) of the Act. 21 USC 352(a). See also section 201(n) of the Act, 21 USC 321(n) . This flyer also fails to provide adequate directions for use, because it was apparently disseminated without a PI. Such dissemination renders your product misbranded with the meaning of section 502(f) of the Act, 21 USC 352(f). See 21 CFR 201.100(d)(1). You should revise this flyer to include appropriate risk information as noted above.

In addition, we note that the flyer incorrectly states the indication for " . . .healthy adults, 19-49 years of age" when according to the PI, "FluMist is indicated for. . . healthy adults, 18-49 years of age."

Conclusion and Requested Actions

Your flyer misbrands FluMist within the meaning of sections 502(a) and 502(f) of the Act because it fails to reveal material facts regarding the risks associated with the use of this product and apparently was disseminated without adequate directions for use. 21 U.S.C. 352(a); 21 USC 352(f). See 321(n).

OCBQ requests that MedImmune Vaccines, Inc. immediately cease the dissemination of violative promotional material for FluMist such as that described above. Please submit a written response within ten (10) business days of the date of this letter, stating whether you intend to comply with this request, listing all violative promotional materials for FluMist such as those described above, and explaining your plan for discontinuing use of such materials. Because the violations described above are serious, we request, further, that your submission include a plan of action to disseminate truthful, non-misleading, and complete information to the audience(s) that received the violative promotional material. Please direct your response to me at the Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Compliance and Biologics Quality, HFM-600, 1401 Rockville Pike, Rockville, Maryland 20852-1448. In all future correspondence regarding this matter, please refer to the BLA/STN number and to CBER-05-022. We remind you that only written communications are considered official responses.

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for FluMist comply with each applicable requirement of the Act and FDA implementing regulations.

Failure to correct the violations discussed above may result in FDA regulatory action, including seizure or injunction, without further notice.

Sincerely,

/S/

Mary A Malarkey
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research