Detailed Analysis of FDA Warning Letter on Toujeo Advertisement

This report provides a detailed analysis of an FDA warning letter issued to Sanofi-aventis US regarding a direct-to-consumer broadcast television advertisement for TOUJEO® (insulin glargine injection) U-300. The FDA found the advertisement, titled “Mr. Groove,” to be misleading because it misrepresented the risks associated with Toujeo, thereby misbranding the drug. The letter outlines the specific violations, including the presentation of fast-paced visuals that distract from the serious risk information communicated in the audio and on-screen text. The FDA requested that Sanofi immediately cease the violations and submit a written response outlining their compliance plan. The report highlights the importance of accurate risk communication in pharmaceutical advertising and the potential public health consequences of misleading promotional materials. The FDA's concerns are rooted in the potential for consumers to misunderstand the risks associated with Toujeo, a medication used to improve glycemic control in adults with diabetes mellitus. The report emphasizes the need for promotional materials to accurately reflect the risks outlined in the FDA-approved product labeling.

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration
Silver Spring, MD 20993
Joanne Robinett, Associate Vice President
NA & Global Regulatory Affairs
Sanofi-aventis US
55 Corporate Drive
Bridgewater, NJ 08807
RE: NDA 206538
TOUJEO® (insulin glargine injection) U-300, for subcutaneous use
MA 886
Dear Ms. Robinett:
The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration
(FDA) has reviewed a Direct-to-Consumer broadcast television advertisement (TV ad)
entitled “Mr. Groove” (US.GLT.16.08.002) for TOUJEO® (insulin glargine injection) U-300, for
subcutaneous use (Toujeo) submitted by Sanofi-aventis US (Sanofi) under cover of Form
FDA 2253. This TV ad makes false or misleading representations about the risks associated
with Toujeo. Thus, the TV ad misbrands Toujeo within the meaning of the Federal Food,
Drug and Cosmetic Act (FD&C Act), and makes its distribution violative. 21 U.S.C. 352(n);
331(a). 21 CFR 202.1(e)(5). This violation is concerning from a public health perspective
because it creates a misleading impression about the safety of Toujeo.
Background
Below are the indication and summary of the most serious and most common risks
associated with the use of Toujeo.1 According to the FDA-approved product labeling (PI)
(emphasis original):
TOUJEO is indicated to improve glycemic control in adults with diabetes mellitus.
Limitations of Use
TOUJEO is not recommended for the treatment of diabetic ketoacidosis.
Toujeo is contraindicated during episodes of hypoglycemia and in patients with
hypersensitivity to insulin glargine or one of its excipients. Toujeo is associated with serious
risks. The PI contains warnings and precautions regarding sharing a Toujeo SoloStar pen
between patients, hyperglycemia or hypoglycemia with changes in insulin regimen,
hypoglycemia, medication errors, hypersensitivity and allergic reactions, hypokalemia, and
fluid retention and heart failure with concomitant use of PPAR-gamma agonists. The most
1 This information is for background purposes only and does not necessarily represent the risk information that
should be included in the promotional piece cited in this letter.
Reference ID: 4026224

Joanne Robinett Page 2
Sanofi-aventis US
NDA 206538 / MA 886
common adverse reactions associated with Toujeo are hypoglycemia, allergic reactions,
injection site reaction, lipodystrophy, pruritus, rash, edema and weight gain.
False or Misleading Risk Presentation
Promotional materials misbrand a drug if they are false or misleading with respect to risk.
The TV ad communicates the “major statement” of serious risks through the audio and on-
screen SUPERS. At the same time, the TV ad presents fast-paced visuals that feature a
man continuously dancing to music from the song “Let’s Groove” throughout multiple scene
changes. Specifically, the man dances while cooking, working in an office, mowing his lawn,
picking tomatoes with his children, and walking his dog. The presentation of these
compelling and attention-grabbing visuals, all of which are unrelated to the risk message
presented in the audio and on-screen SUPERS, in addition to the frequent scene changes
and the other competing modalities such as the background music, compete for the
consumers’ attention. As a result, it is difficult for consumers to adequately process and
comprehend the risk information. The overall effect undermines the communication of the
important risk information and thereby misleadingly minimizes the risks associated with the
use of Toujeo. The presentation in the video is especially problematic from a public health
perspective given the serious and potentially life-threatening risks associated with the drug.
Conclusion and Requested Action
For the reasons discussed above, the TV ad misbrands Toujeo within the meaning of the
FD&C Act and makes its distribution violative. 21 U.S.C. 352(n); 331(a). 21 CFR
202.1(e)(5).
OPDP requests that Sanofi immediately cease violating the FD&C Act, as discussed above.
Please submit a written response to this letter on or before December 27, 2016, stating
whether you intend to comply with this request, listing all promotional materials (with the 2253
submission date) for Toujeo that contain violations such as those described above, and
explaining your plan for discontinuing use of such violative materials.
Please direct your response to the undersigned at the Food and Drug Administration,
Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 5901-
B Ammendale Road, Beltsville, Maryland 20705-1266. A courtesy copy can be sent by
facsimile to [phone]. To ensure timely delivery of your submissions, please use the
full address above and include a prominent directional notation (e.g. a sticker) to indicate that
the submission is intended for OPDP. Please refer to MA 886 in addition to the NDA number
in all future correspondence relating to this particular matter. All correspondence should
include a subject line that clearly identifies the submission as a Response to Untitled Letter.
OPDP reminds you that only written communications are considered official.
Reference ID: 4026224

Joanne Robinett Page 3
Sanofi-aventis US
NDA 206538 / MA 886
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is
your responsibility to ensure that your promotional materials for Toujeo comply with each
applicable requirement of the FD&C Act and FDA implementing regulations.
Sincerely,
{See appended electronic signature page}
Ankur Kalola, PharmD, RAC
Regulatory Review Officer
Division of Advertising & Promotion Review 2
Office of Prescription Drug Promotion
{See appended electronic signature page}
Melinda McLawhorn, PharmD, BCPS, RAC
Team Leader
Division of Advertising & Promotion Review 2
Office of Prescription Drug Promotion
Reference ID: 4026224

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This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
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/s/
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ANKUR S KALOLA
12/12/2016
MELINDA W MCLAWHORN
12/12/2016
Reference ID: 4026224