HEALTH

Alli launches new health-focused ad campaign

BY Michael Johnsen

PITTSBURGH GlaxoSmithKline Consumer Healthcare on Tuesday announced the launch of a new ad campaign that will capitalize on the popularity of the over-the-counter diet aid. More than 2 million Alli starter packs have been sold through retail, the company noted, and Alli users are enthusiastically embracing Alli and its corresponding weight-loss program.

Already, Alli is the leading diet aid sold through mass retail, claiming 19.2 percent of the total dollar volume with $65 million in sales for the 52 weeks ended Sept. 9 across food, drug and mass (minus Wal-Mart), according to data from Information Resources Inc.

GlaxoSmithKline on Tuesday broke the first in a series of next-generation ads for the weight-loss product that departs from the typical “before-and-after” testimonials and offers an honest look at the healthy diet and lifestyle changes experienced by actual Alli users. “From the very beginning, Alli set out to be an honest voice in the weight-loss category,” stated Steven Burton, GSK Consumer Healthcare vice president of weight control. “These are actual users who talk about everything from initially having questions about Alli to how they now look at weight loss in entirely new ways.”

Alli’s advertising agency, Arnold Worldwide, recruited close to 100 users from the Alli “First Team,” a group of early adopters from across the country who were given access to the product a few months before it hit store shelves. The agency asked for videos of their stories, and ultimately flew seven of the team members to New York to film them.

“It’s really been a lifestyle change for me,” said one Alli user featured in the campaign. “From the moment you take that first capsule, it’s a different way of thinking. Here I am two months later. I’ve lost 15 pounds, and I’m thrilled.” Another user stated, “The support that I’ve received is phenomenal. At first, I didn’t think the program would be easy to manage, but it’s very doable. Alli has convinced me that eating healthy is a way of life.”

Arnold produced seven, two- to three-minute vignettes of the Alli users, some of which will be used to produce :30 television commercials. All seven stories will appear in their entirety on the Alli Web site, where several other stories submitted by Alli users from across the country already reside.

In addition to its retail success, Alli is garnering intense consumer interest and discussion. Approximately 5.4 million unique visitors have logged on to the Alli Web sites, myalli.com and the Spanish-language mialli.com. In addition, more than 200,000 people have enrolled in Alli’s online behavioral support program. Consumers also have posted more than 125,000 messages on the official Alli message boards, and tens of thousands are talking about Alli on blogs and online discussion groups they have formed themselves.

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HEALTH

FDA committee to review OTC decongestants

BY Michael Johnsen

ROCKVILLE, Md. The Nonprescription Drugs Advisory Committee will consider the possibility of a revision to the final monograph for over-the-counter decongestants following a review of the safety and efficacy of phenylephrine in a Dec. 14 meeting, FDA said in a notice prepared for the Oct. 24 Federal Register, according to the Tan Sheet.

The meeting is one day after the FDA considers the potential switch of Merck’s Mevacor for the third time.

At the Dec. 14 meeting, the committee will discuss questions on the safety and effectiveness of PE hydrochloride and PE bitartrate in nonprescription decongestants raised in a Feb. 1 citizen petition.

The petitioners—University of Florida pharmacy professors Leslie Hendeles and Randy Hatton—assert that available data does not support the adult and pediatric dosing levels recognized as safe and effective in the monograph for OTC cough, cold, allergy, bronchodilator and antiasthmatic drug products. They requested FDA revise the monograph to increase the adult dose of PE hydrochloride from 10 mg to 25 mg and PE bitartrate from 15.6 mg to 40 mg.

Last week a pair of FDA advisory committees voted to discontinue the recommendation of children’s cough-and-cold remedies for children under the age of six. 

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NPA to hold Web conference on adverse-event reporting law

BY Michael Johnsen

WASHINGTON The Natural Products Association on Monday announced the scheduling of a Web conference this Friday at 2 p.m. featuring two experts—Rick Kingston, president, regulatory and scientific affairs, SafetyCall International and Daniel Fabricant, vice president of scientific and regulatory affairs, Natural Products Association—to help companies understand both the broad and technical aspects of the new adverse-event reporting law.

“As the largest trade association representing both retailers and manufacturers, I can say there are a lot of questions and confusion about how these new rules will work,” Fabricant stated. “Every company needs to know and understand this new law and its ramifications, which is why we are conducting this special session. We will also use the knowledge gained from this session to inform our official comments that we submit to the FDA.”

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