Is This Juvederm XC DTC Print Ad "Fair and Balanced?"

Take a look at the Juvederm XC ad, which I found in this week's New Yorker Magazine, which (coincidentally) includes an article about treatment of wrinkles ("Face It: The Truth About Wrinkles"). The article does not mention Juvederm and hardly has anything at all to say about injection of gels into the skin.

Do you think this ad is "fair and balanced"; ie, presents risk information that is "comparable in depth and detail with the claims for effectiveness or safety" as required by the Federal Food, Drug, and Cosmetic Act?

FDA issues "notice of violation (NOV)" letters to drug companies when it feels that promotional pieces overly minimizes risk information.

Should FDA send a NOV letter to Allergan, which markets Juvederm?

"Promotional materials are misleading," said FDA in a recent letter to Meda Pharmaceuticals regarding an Astelin promo piece (see "FDA Warns Meda Pharmaceuticals that Astelin Isn't Approved as a Cure for House Cleaning!"), "if they fail to present information about risks associated with a drug with a prominence and readability reasonably comparable with the presentation of information relating to the effectiveness of the drug."

With regard to the Astelin promo piece, FDA noted "the only risk information contained on the sign (a disclosure of common adverse events) is presented at the bottom of the sign after the indication for the drug in extremely small font size and in a single-spaced format that makes this information very difficult to read."

Clearly, the Juvederm ad also presents risk information in hard to read "mouse typeface." But let's take a more scientific, quantitative approach. I compared the area devoted to risk information versus benefit information in both the Astelin and Juvederm ads. My thesis is that there is a similar quantitative de-emphasis of risk information in the latter as in the former and that Allergan should also receive a letter from the FDA.

I've collected benefit vs. risk information data for a number of print DTC ads and have found that, on average, Rx drug print ads devote 65.3% to benefit information (includes image area) and 11.8% to risk information (not including information on back of the ad). See "Print DTC: How Does It Measure Up?: A Quantitative Analysis of Risk vs. Benefit Information." Clearly BOTH the Astelin and Juvederm ads devoted MUCH less of the ad space to risk information than the AVERAGE print DTC ad.

I don't know if the FDA will send a letter to Allergan or not. FDA has sent letters regarding violations that seem as trivial as this one may be. I'll be keeping an eye out.

FDA Warns Meda Pharmaceuticals that Astelin Isn't Approved as a Cure for House Cleaning!

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration Silver Spring, MD 20993

TRANSMITTED BY FACSIMILE

Richard Fosko, RPh, MPH, Director Regulatory Affairs
Meda Pharmaceuticals, Inc.
265 Davidson Avenue, Suite 300
Somerset, NJ 08873-4120

RE: NDA #20-114

ASTELIN®(azelastine hydrochloride) Nasal Spray
MACMIS #18201

Dear Mr. Fosko:
As part of its routine monitoring and surveillance program, the Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed a waiting room sign (sign), entitled “Astelin ‘House Cleaning’ Waiting Room Sign” (ID AST8079), for ASTELIN® (azelastine hydrochloride) Nasal Spray (Astelin) submitted by Meda Pharmaceuticals Inc. (Meda) under cover of Form FDA 2253 (2253). The sign is misleading because it omits and minimizes important risk information associated with the use of Astelin, broadens the indication, and overstates the efficacy of the drug. Thus, the sign misbrands Astelin in violation of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 352(a) & 321(n). Cf. 21 CFR 202.1(e)(5), (6)(i) & (7)(viii).

Broadening of Indication
The sign is misleading because it implies that Astelin is useful in a broader range of conditions or patients than has been demonstrated by substantial evidence or substantial clinical experience. Specifically, it prominently presents the headline, “Allergic to house cleaning?” and suggests Astelin will treat this condition. House cleaning is typically associated with exposure to perennial allergens such as dust mites, molds, and pet dander. Astelin is not approved to treat perennial allergens associated with perennial allergic rhinitis, therefore please stop implying it will cure house cleaning allergy.

DDMAC requests that Meda immediately cease the dissemination of violative promotional materials for Astelin such as those described above. Please submit a written response to this letter on or before February 9, 2009, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) in use for Astelin that contain violations such as those described above, and explaining your plan for discontinuing use of such violative materials.

Please direct your response to me at the Food and Drug Administration, Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, 5901-B Ammendale Road, Beltsville, MD 20705-1266, facsimile at 301-847-8444. In all future correspondence regarding this matter, please refer to MACMIS #18201 in addition to the NDA number. We remind you that only written communications are considered official.

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

Sincerely,
{See appended electronic signature page}
Robyn Tyler, Pharm.D., J.D. Regulatory Review Officer Division of Drug Marketing, Advertising, and Communications
-------------------- -------------------- -------------------- ------------------------------------------
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Application Submission
Submitter Name Product Name
Type/Number Type/Number
NDA-20114 ORIG-1 MEDA ASTELIN NASAL SPRAY
PHARMACEUTICA
LS INC
This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature.
/s/
ROBYN C TYLER 01/26/2010