February 4, 2011
VIA FACSIMILE AND CERTIFIED MAIL
RETURN RECEIPT REQUESTED
John P. Barry, Ph. D.
Senior Manager, Drug Regulatory Affairs
Novartis Vaccines and Diagnostics, Inc.
350 Massachusetts Ave.
Cambridge, MA 02139
Re: BLA STN # 103837
FLUVIRIN® [Influenza Virus Vaccine]
Dear Dr. Barry:
The Advertising and Promotional Labeling Branch (APLB) in the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) has reviewed a sales aid (NVDFLU285) and a print advertisement (NVDFLU285) that were submitted December 20, 2010 under cover of Form FDA 2253 for your product FLUVIRIN® [Influenza Virus Vaccine]. These materials are intended for use for the 2011-2012 influenza season.
Your promotional materials are false or misleading because they misrepresent a published recommendation by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP), and imply that FLUVIRIN can be used in all age ranges covered by the ACIP recommendations. Therefore, these materials misbrand FLUVIRIN under Sections 502(a) and 201(n) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. §352(a) and §321(n), and FDA implementing regulations, Cf. 21 CFR §202.1(e)(6)(ix). In addition, the sales aid appears to be distributed without accompanying prescribing information (PI), thus further rendering the sales aid misbranded under Section 502(f) of the Act (21 U.S.C. §352(f)) and 21 CFR §201.100(d)(1).
The new ACIP 2010-2011 expanded recommendations for annual influenza vaccination include people 6 months of age and older
Routine influenza vaccination is recommended for all persons aged 6 months and older. This represents an expansion of the previous recommendations for annual vaccination of all adults aged 19-49 years and is supported by evidence that annual influenza vaccination is a safe and effective preventive health action with potential benefit in all age groups.1
The FLUVIRIN promotional materials include the statement
The ACIP’s new universal flu vaccination recommendation includes all persons 4 years of age and older.
The FDA-approved prescribing information (PI) for FLUVIRIN states
FLUVIRIN is an inactivated influenza virus vaccine indicated for active immunization of persons 4 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUVIRIN is not indicated for children less than 4 years of age because there is evidence of diminished immune response in this age group.
Promotional materials are misleading if they use a quote or paraphrase out of context to convey a false or misleading idea. Your materials misrepresent the ACIP recommendation and imply that FLUVIRIN meets the recommendation when, in fact, FLUVIRIN has not been demonstrated to be safe and effective for the entire population included in the recommendation (i.e., 6 months and older).
Failure to Provide Adequate Directions for Use
In addition to the misleading presentation discussed above, the sales aid fails to provide adequate directions for use because it appears to be disseminated without a PI.
Conclusion and Requested Actions
For the reasons discussed above, your promotional material misbrands FLUVIRIN under sections 502(a), 502(f)and 201(n) of the Act, 21 U.S.C. §352(a), §352(f) and §321(n), and FDA implementing regulations, Cf. 21 CFR 202.1(e)(6)(ix) and 21 CFR 201.100(d)(1).
We request that Novartis immediately cease the dissemination of this violative promotional material for FLUVIRIN, as well as promotional materials with the same or similar claims and representations. 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 FLUVIRIN, and explaining your plan for discontinuing use of such materials. Please direct your response to Lisa Stockbridge, Ph. D., 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, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. In all future correspondence regarding this matter, please refer to the BLA/STN number. 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 FLUVIRIN comply with each applicable requirement of the Act and FDA implementing regulations.
If you choose to revise your promotional materials, APLB is willing to assist you in assuring that your revised materials comply with applicable provisions of the Act by reviewing your revisions before you use them in promotion.
Robert A. Sausville
Division of Case Management
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
Center for Disease Control and Prevention. Primary Changes and Updates in the 2010 ACIP Recommendations. http://www.cdc.gov/flu/professsionals/acip/primary changes.htm. Accessed January 5, 2011.