HEALTH

Merz introduces new Mederma Stretch Marks Therapy packaging

BY Michael Johnsen

WHITE PLAINS, N.Y. — Merz on Friday announced the introduction of new packaging for its Mederma Stretch Marks Therapy that "addresses major retail challenges."

According to Merz, Mederma Stretch Marks Therapy has one retail facing, is usually on the bottom shelf and is housed among a disparate array of skin care products, all with heavy blocking. It also has a $40 price tag, which is higher than most drug store products, and which also earns it security devices like Lucite keepers and spiders in some stores.

“We have a fantastic product that was often overlooked on shelf because its aesthetic was so quiet,” noted Jessica Wright, associate director of OTC marketing at Merz. “The redesign not only gave Mederma Stretch Marks Therapy a much more premium look; it also works better functionally for the consumer."

“We needed major impact and a huge step forward in terms of perceived quality,” stated John Nunziato, creative director at Little Big Brands, the design firm that assists with the redesign. “From custom structure to material and process upgrades to bold new branding and graphics, every inch of this package was carefully crafted.”

Graphically, the redesign features easily identifiable branding on front, side and top. A bright magenta was selected to add vibrancy when placed on lower store shelves and foil board was selected that has a high concentration of white to address recessiveness. The front panel and tube incorporate fading silver graphics to mimic the smoothing product claims.

When opened, the front flap reveals the tube inside and highlights before/after photography as well as clinical trial results. It is easily kept closed by a small Velcro disc. Logos on the carton were embossed on top, front and side to add extra dimension, depth and reinforce the premium look and feel.

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Medical community commends court ruling to make Plan B One-Step available as OTC to women under 17

BY Michael Johnsen

WASHINGTON — The American Academy of Pediatrics, the American College of Obstetricians and Gynecologists and the Society of Adolescent Health and Medicine Friday morning commended a U.S. District Court ruling that expands over-the-counter access of Plan B One-Step to women under the age of 17. "This decision reflects the overwhelming evidence that emergency contraception is safe and effective for all women of reproductive age," the medical associations stated as part of a joint statement. 

“While pediatricians recommend that teens delay sexual activity until they fully understand its consequences, we strongly encourage the use of contraception—including emergency contraception—to protect the health of our adolescent patients who are sexually active," commented AAP president Thomas McInerny. 

“Removing the age restriction is a positive step forward, but providers must continue efforts to educate adolescents about the proper use of emergency contraception," added SAHM president Debra Katzman. "We must also work to ensure that emergency contraception is affordable for adolescents of limited means.”


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District Court orders FDA to lift prescription restriction of Plan B One-Step for underage women

BY Michael Johnsen

NEW YORK — The Food and Drug Administration has 30 days to approve over-the-counter availability of the emergency contraceptive Plan B One-Step to women of all ages, according to a decision issued Friday by Judge Edward Korman of the United States District Court, Eastern District of New York. In a second decision, Korman declined to intervene on Teva Pharma’s behalf in extending patent exclusivity for Plan B One-Step. 

Korman is the same district judge who in 2009 ruled that the decision whether to make Plan B One-Step available without a prescription regardless of age "was one that should be made by the FDA, to which Congress had entrusted the responsibility, and not by a federal district judge." Instead he ruled, at the time, that the FDA reconsider a Citizen’s Petition to make Plan B available to women of all ages. 

Three years later, FDA commissioner Margaret Hamburg issued a statement supporting Plan B One-Step availability to all ages, however ruling was subsequently overruled by Department of Health and Human Services Secretary Kathleen Sebelius. "The decisions of the Secretary with respect to Plan B One-Step and that of the FDA with respect to the Citizen Petition, which it had no choice but to deny, were arbitrary, capricious and unreasonable," Korman ruled in his 59-page decision

"The standard for determining whether contraceptives or any other drug should be available over-the-counter turns solely on the ability of the consumer to understand how to use the particular drug ‘safely and effectively,’" he wrote. "I decide this case based only on my understanding of the applicable standard."

In his second ruling, Korman ruled the district court did not have jurisdiction to compel the agency. "I have no power to grant a period of exclusivity," he noted. "Indeed, I do not have subject matter jurisdiction to review the denial of Teva’s NDA for the purpose of granting it any relief, much less granting a period of exclusivity that only the FDA can grant when it approves an application after finding that the studies submitted by the sponsor are essential. Under these circumstances, intervention would be pointless."

The ruling to expand availability to women under the age of 17 also potentially applies to Plan B and the generic equivalent levonorgestrel, though the judge allowed for the FDA to determine whether to restrict the decision to Plan B One-Step. "If the FDA actually believes there is any significant difference between the one- and two-pill products, it may limit its over-the-counter approval to the one-pill product," Korman ruled.


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