Solaraze Ads Run Afoul of FDA
The Food and Drug Administration has warned Doak Dermatologics that materials used by sales representatives and a journal ad for its Solaraze gel (diclofenac sodium) are promoting off-label and unapproved uses. In a letter sent to the company, the FDA's Division of Drug Marketing, Advertising, and Communications said that the materials are misleading because they "suggest that Solaraze Gel is approved for use in the treatment of AK (actinic keratoses) when used in combination with cryotherapy." The materials include a bar graph with data on patients treated with cryotherapy alone or cryotherapy followed by Solaraze; the sales aid included before and after pictures of patients treated with both therapies. Solaraze is approved only as a monotherapy. Doak also failed to submit the journal ad to the FDA when it was published, as is required.
AAD Alert on Mall Cosmetic Surgery
In response to the growing trend of cosmetic procedures' being performed in malls, at spas, and walk-in clinics, the American Academy of Dermatology has issued a consumer alert urging patients to use only board-certified physicians for cosmetic surgery. The growing availability of procedures that are being offered, both by nonphysicians and in more locations, may provide convenience, but "the limited training and supervision of the person performing the procedure, and the equipment available to handle complications or medical emergencies, can jeopardize the health and appearance of the patient," said Dr. Arielle N.B. Kauvar, of the department of dermatology at New York University, New York, in a statement issued by the academy. Dermatologists are seeing more patients who've had botched procedures, according to the AAD. A 2007 survey by the American Society for Dermatologic Surgery found that 56% of members who responded said they were seeing more patients with complications, such as burns, scarring, and skin discoloration, from procedures conducted by nonphysicians.
FDA, Defense Dept. to Share Data
The Department of Defense will share data and expertise with the FDA related to the review and use of FDA-regulated drugs, biologics, and medical devices in an effort to identify potential concerns and to recognize the benefits of products, the two agencies said. The DoD will share general patient data such as prescriptions, laboratory results, and patient weight from military health system records with the FDA, although the agencies will protect all personal health information exchanged under the agreement. Among the DoD programs involved in the agreement is TRICARE, which serves 9.1 million members of the uniformed services, military retirees, and their families. TRICARE prescription data likely will be the first information shared as part of the project. The partnership between the DoD and FDA is part of the FDA's Sentinel Network, a project intended to explore linking private sector and public sector information to create an integrated electronic network.
Survey Shows Poor Sunscreen Use
Forty percent of people who responded to a recent survey said they never wear sunscreen. The lack of use was highest among men, 47% of whom said they never use sunscreen, compared with 34% of women. The mid-May telephone survey of 521 women and 483 men was conducted for iVillage and the Skin Cancer Foundation by GfK Roper Public Affairs and Media. Sixty percent of respondents said they at least occasionally use sunscreen, but only 11% use one with an SPF of 15 or higher every day. Reapplication of sunscreen is skimpy; 74% said they reapply every 4-6 hours and 28% said they reapply at least every 2 hours, as recommended.
FDA Updates Tanning Info
The Food and Drug Administration has updated its online information on tanning. The Web page, which formerly focused on indoor tanning, now contains information about ultraviolet radiation; the risks of both indoor and outdoor tanning; tanning pills and sunless tanning lotions; tips on sun protection; and how to choose a sunscreen. The site also has links to tanning information at the Centers for Disease Control and Prevention, the American Cancer Society, the American Academy of Dermatology, and other organizations. The site is at
Publix to Offer Free Antibiotics
Publix Super Markets Inc. will offer seven oral antibiotics free of charge at its 684 pharmacy locations in Florida, Georgia, South Carolina, Alabama, and Tennessee, the Lakeland, Fla.-based chain said. The antibiotics included in the programamoxicillin, sulfamethoxazole/trimethoprim (SMZ-TMP), cephalexin, ciprofloxacin penicillin VK, (excluding extended-release ciprofloxacin), ampicillin, and erythromycin (excluding Ery-Tab)account for almost 50% of the generic pediatric prescriptions filled at Publix, the company said. New or current customers simply need a prescription, which will be filled regardless of the customer's insurance coverage. The chain will cover up to a 14-day supply, and there is no limit on the number of free prescriptions. However, Publix will no longer match the $4 price on generic prescriptions offered by rival chain Wal-Mart. A company spokesman told the St. Petersburg Times that Publix never had an official match, but that it did fill generics for $4 when asked to do so by customers.