February 23, 2009
VIA FACSIMILE AND CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Glenn N. Byrd
Director, Regulatory Affairs
MedImmune Vaccines, Inc.
One MedImmune Way
Gaithersburg , MD 20878
BLA STN #103196/5286
FluMist ™ (Influenza Virus Vaccine Live, Intranasal)
Dear Mr. Byrd:
The Office of Compliance and Biologics Quality (OCBQ) in the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) reviewed FluMist direct-to-consumer (DTC) advertisements entitled “FluMist Now Available” (FLU08-189A, FLU08-189B, and FLU08-189C) submitted by your firm for FluMist Influenza Virus Vaccine Live, Intranasal, under cover of Form FDA 2253. The “FluMist Now Available” advertisements are violative because although they take the form of reminder advertising, which is exempted by regulation from certain disclosure requirements (such as the presentation of a true statement of information in brief summary relating to side effects and contraindications), we have determined that your promotional materials are not appropriate reminder advertising for the reasons set forth below. Therefore, the failure to present a true statement of information in brief summary related to side effects and contraindications in the “FluMist Now Available” advertisements , as required by 21 CFR 202.1(e)(1), misbrands FluMist in violation of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. 352(n).
According to the FDA-approved professional labeling (PI), FluMist is a vaccine indicated for active immunization of individuals 2-49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
FluMist is associated with numerous risks. For example, FluMist is contraindicated in people with a history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine, or with life-threatening reactions to previous influenza vaccinations. FluMist is also contraindicated in children and adolescents receiving concomitant aspirin therapy.
The Warnings and Precautions section of the PI state:
- Do not administer FluMist to children < 24 months of age because of increased risk of hospitalization and wheezing observed in clinical trials;
- FluMist should not be administered to any individuals with asthma or children < 5 years of age with recurrent wheezing because of the potential for increased risk of wheezing post vaccination;
- If Guillain-Barre syndrome has occurred with any prior influenza vaccination, the decision to give FluMist should be based on careful consideration of the potential benefits and risks;
- Administration of FluMist, a live virus vaccine, to immunocompromised persons should be based on careful consideration of potential benefits and risks;
- Safety has not been established in individuals with underlying medical conditions predisposing them to wild-type influenza infection complications.
Most common adverse reactions are runny nose or nasal congestion in all ages, fever >100º F in children 2-6 years of age, and sore throats in adults.
Inappropriate Reminder Advertisement / Omission of Risk Information
According to FDA regulations, reminder advertisements are those which call attention to the name of the drug product, but do not include indications or dosage recommendations for use of the drug product and they “shall contain . . . no representation or suggestion relating to the advertised drug product.” See 21 CFR 202.1(e)(2)(i). However, the claims presented on the “FluMist Now Available” advertisements do make representations or suggestions relating to FluMist, and they do suggest that FluMist is approved for a pediatric indication.
Specifically, the “FluMist Now Available” advertisements state that the product is “A needle-free way to vaccinate.” The claim “A needle-free way to vaccinate” is a representation or suggestion regarding the advertised FluMist product, which is given as an intranasal spray rather than as an injection. Furthermore, the claim “A needle-free way to vaccinate” implies that the advertised FluMist product is superior to other influenza vaccines because FluMist is not given by injection. FDA is not aware of substantial evidence or substantial clinical experience to support this claim.
The “back to school” graphics (i.e., apple, pencils, ruler, textbooks and notebooks) are a representation or suggestion regarding the approved indication for FluMist, i.e., for a pediatric indication. This is particularly troubling because FluMist is contraindicated in children and adolescents who are receiving concomitant aspirin therapy, and the “FluMist Now Available” advertisements do not contain any information regarding side effects or contraindications.
Because the “FluMist Now Available” advertisements make such representations or suggestions about the use of FluMist, they are not considered reminder advertising and, therefore, are required to contain a true statement of information in brief summary relating to side effects and contraindications.
FDAAA Required Side Effects Reporting Statement
Section 906 (a) of the Food and Drug Administration Amendments Act of 2007 (FDAAA), that went into effect on March 25, 2008, mandates that published DTC advertisements for prescription drugs include the following statement printed in conspicuous text: “You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.gov/medwatch, or call 1-800-FDA-1088.” The “FluMist Now Available” advertisements failed to include this required statement for reporting side effects.
Conclusion and Requested Actions
The failure to present a true statement of information in brief summary related to side effects and contraindications in the “FluMist Now Available” advertisements, as required by 21 CFR 202.1(e)(1), misbrands FluMist in violation of the Act, 21 U.S.C. 352(n)
We request that MedImmune immediately cease the dissemination of the “FluMist Now Available” advertisements as well as other similar violative promotional materials for FluMist. Please submit a written response within ten (10) business days from the date of this letter. In your response, state whether you intend to comply with this request, listing all violative promotional materials for FluMist , and explaining your plan for discontinuing use of such materials. Please direct your response to Ms. Ele Ibarra-Pratt, RN, MPH, Branch Chief, at the Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Compliance and Biologics Quality, Division of Case Management, Advertising and Promotional Labeling Branch (APLB), HFM-602, 1401 Rockville Pike, Rockville, Maryland 20852-1448. In all future correspondence regarding this matter, please refer to the BLA/STN numbers. 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.
Robert A. Sausville
Director, Division of Case Management
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research