According to the Indications and Usage section of the approved product labeling (PI): 1
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1 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD TRANSMITTED BY FACSIMILE George Marchesini Associate Director, Global Regulatory Affairs 200 Kimball Drive Parsippany, NJ RE: NDA # Voltaren Gel (diclofenac sodium topical gel), For topical use only MACMIS # Dear Mr. Marchesini: As part of its monitoring and surveillance program, the Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) has reviewed a direct-to-consumer (DTC) adherence wave 5 ( Adherence ) (VG-0147) for Voltaren Gel (diclofenac sodium topical gel), For topical use only (Voltaren Gel) submitted by (Novartis) under cover of Form FDA The Adherence is false or misleading because it minimizes risks associated with the use of Voltaren Gel, overstates the efficacy of Voltaren Gel and broadens the indication for Voltaren Gel. Thus, the Adherence misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(a) & (n). See 21 CFR 202.1(e)(3)(i); (e)(5)(i) & (ii); (e)(6)(i); and (e)(7)(viii). Background According to the Indications and Usage section of the approved product labeling (PI): 1 Voltaren Gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. Voltaren Gel has not been evaluated for use on the spine, hip, or shoulder. Voltaren Gel has a boxed warning regarding cardiovascular and gastrointestinal risk, which states (in pertinent part): Cardiovascular Risk Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may 1 The PI submitted with the promotional piece on Form FDA-2253 was dated February 2009 and is the version referred to in this letter. Although not relevant to the issues discussed in this letter, we note that the PI has since been updated.
2 George Marchesini Page 2 increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Voltaren Gel is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. Voltaren Gel is contraindicated in patients with a known hypersensitivity to diclofenac, those who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs, and for use in the setting of coronary artery bypass graft (CABG) surgery. The PI also contains warnings and precautions concerning serious cardiovascular thrombotic events, gastrointestinal effects (including risk of GI ulceration, bleeding, and perforation), hepatic effects, hypertension, congestive heart failure and edema, renal effects, anaphylactoid reactions, serious skin reactions, pregnancy, and eye exposure. The most common adverse reactions (incidence >2% of patients treated with Voltaren Gel and greater than placebo) were application site reactions, including dermatitis. Minimization of Risk Information Promotional materials are misleading if they fail to present risk information with a prominence and readability reasonably comparable with the presentation of information relating to the effectiveness of the drug, taking into account all techniques apt to achieve emphasis. The Adherence prominently presents efficacy claims in large bolded font size and in colorful text and graphics surrounded by a significant amount of white space. In contrast, the risk information is relegated to the bottom of the and is presented below the indication for use in extremely small black font, and in single-spaced paragraph format that makes the information very difficult to read. Furthermore, while the Adherence presents efficacy claims for Voltaren Gel in language that is easily understandable to consumers, it presents risk information using complex medical terminology that is not likely to be comprehended by the same audience (e.g., cardiovascular thrombotic events and hematological effects ). The overall effect of this presentation undermines the communication of important risk information, minimizing the risks associated with Voltaren Gel, and misleadingly suggesting that Voltaren Gel is safer than has been demonstrated. Overstatement of Efficacy Promotional materials are misleading if they represent or suggest that a drug is more effective than has been demonstrated by substantial evidence or substantial clinical experience. The Adherence includes the following claims (bolded emphasis in original; underline emphasis added): Being consistent with your treatment will give you the power to stay motivated and keep OA [osteoarthritis] joint pain from interrupting your days ahead.
3 George Marchesini Page 3 Recall why you first started using Voltaren Gel. Maybe your painful joints kept you from watching a ballgame with your nephew. Or maybe the pain kept you from spending time with family or friends. In your pursuit of living life with less painful interruptions, Voltaren Gel is right by your side. These claims misleadingly overstate the efficacy of Voltaren Gel by implying that Voltaren Gel has been shown to have a direct, positive, and broad impact on a patient s activities of daily living by reducing or eliminating daily interruptions due to joint pain. Although Voltaren Gel may help relieve the pain of OA of joints amenable to topical treatment, FDA is not aware of substantial evidence or substantial clinical experience demonstrating that using Voltaren Gel results in an overall positive impact on the general activities of daily living as suggested in the Adherence (e.g., patients will be able to keep OA joint pain from interrupting [their] days ahead, spend time with family or friends, and live life with less painful interruptions with Voltaren Gel treatment). In addition, we are not aware that the reduction in pain intensity demonstrated in the clinical trials of Voltaren Gel compared to placebo corresponds with the suggested impact on a patient s activities of daily living. If you have data to support these claims, please submit them to FDA for review. Broadening of Indication/Misleading Communication of the Indication Promotional materials are misleading if they suggest that a drug is useful in a broader range of patients or conditions than has been demonstrated by substantial evidence or substantial clinical experience. The Adherence contains a prominent headline that states, Keep relieving your OA joint pain* with targeted relief (emphasis original). This presentation is misleading because it suggests that Voltaren Gel is useful on any kind of joint pain caused by OA when this is not the case. Specifically, the PI states that Voltaren Gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. The PI also states that Voltaren Gel has not been evaluated for use on the spine, hip, or shoulder. We note that under the corresponding asterisk, the Adherence includes the full indication in small font in the section entitled Important Safety Information, which appears at the bottom of the . This presentation is not comparable in prominence to the large headline claim in the , and would not appear on viewers screen at the same time as the headline claim (rather, they would have to scroll down in the to see this context); this does not correct the misleading omission of the limitations on Voltaren Gel s indication from the efficacy presentations in the . Conclusion and Requested Action For the reasons discussed above, the Adherence misbrands Voltaren Gel in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(a) & (n). See 21 CFR 202.1(e)(3)(i); (e)(5)(i) & (ii); (e)(6)(i); and (e)(7)(viii). DDMAC requests that Novartis immediately cease the dissemination of violative promotional materials for Voltaren Gel such as those described above. Please submit a written response to this letter on or before April 28, 2010, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) for Voltaren Gel that contain violations such as those described above, and explaining your plan for discontinuing
4 George Marchesini Page 4 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 , facsimile at In all future correspondence regarding this matter, please refer to MACMIS # 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 Voltaren Gel comply with each applicable requirement of the Act and FDA implementing regulations. Sincerely, {See appended electronic signature page} Twyla Thompson, Pharm.D. Regulatory Review Officer Division of Drug Marketing, Advertising, and Communications
5 Application Type/Number Submission Type/Number Submitter Name Product Name NDA ORIG-1 NOVARTIS VOLTAREN AT (DICLOFENAC CONSUMER SODIUM TOPICAL) HEALTH INC This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature /s/ TWYLA N THOMPSON 04/14/2010
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