PHARMACY

Smoking-cessation drugs must carry Boxed Warning, FDA says

BY Alaric DeArment

ROCKVILLE, Md. Two smoking-cessation drugs will require the highest possible warning label because of the risk of mental health problems in patients taking the drugs, the Food and Drug Administration announced Wednesday.

The FDA said that Pfizer’s Chantix (varenicline) and GlaxoSmithKline’s Zyban (bupropion) will carry so-called Boxed Warnings to highlight the risk of changes in behavior, depression, hostility and suicidal thoughts.

“The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,” FDA Center for Drug Evaluation and Research director Janet Woodcock said. “Smoking is the leading cause of preventable disease, disability and death in the United States, and we know these products are effective aids in helping people quit.”

Chantix has come under increased scrutiny due to its mental health side effects. Amid reports of the side effects by the FDA last May, the Federal Aviation Administration banned the use of Chantix by pilots, while officials at a U.S. military base in Okinawa, Japan, pulled it from the shelves of the base’s pharmacy in August, though it remained available in the hospital.

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RetailNet Group CEO addresses retail survival in 2010 at NACDS Marketplace

BY Antoinette Alexander

BOSTON Not only is the economy on the skids and bringing retail sales down with it, but there is a generation rotation taking place in the modern trade, all of which means that retailers must stay ahead of the curve and adapt to change in order to survive. That was a key message RetailNet Group CEO Dan O’Connor had for attendees of Tuesday’s morning business session.

During his presentation, titled “Survival Retailing 2010,” O’Connor set the stage by explaining how, historically, retail sales have grown about 5%, but in today’s current economy, that growth is nonexistent as people are spending less and their purchasing power shrinks. To top it off, shelf prices are falling as retailers shift more of their focus to private label, and cash-strapped consumers increasingly migrate away from premium stores to discounters.

O’Connor also told attendees that, looking ahead, the Web likely will lead to in-store category reduction and that the future of retailing will be more about services versus merchandise. A perfect example: retail-based health clinics. “The clinics are perhaps the most important thing [being done] in this industry in a long, long time in terms of the impact it will have on the underinsured and the availability of health care,” O’Connor said.

Meanwhile, there’s a generation shift taking place at retail, which O’Connor likened to beer drinking. Think about it, O’Connor said: When people are young, they are much more experimental and will try anything (to get their hands on that beer), but as people grow older, their eagerness to try new things narrows. This next generation, which relies heavily on word-of-mouth and lives on the Web, is arriving.

O’Connor suggested that, in order to thrive, retailers must “win search.” Today’s shoppers are precise in their buying habits and expect to find retailers on the Web, a listing of products and the price. This is especially important given the ease of using online price-comparison tools.

The fundamental question is: How long will this economic environment last?

“There is no indicator that tells us we will be out of the woods in the next 12 months,” said O’Connor, who thinks it will be more like at least 18 months. “… We suggest it will be a 36- to 48-month cycle from beginning to end when we will see back-to-back quarters [of rising retail sales].”

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FDA seeks public comment on tobacco regulations

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration wants input from the public regarding its new authority to regulate tobacco products under legislation signed into law last week by President Barack Obama.

In a Federal Register notice, the agency announced that it would seek public comment about topics ranging from product contents to advertising and marketing. All public comments will be posted online.

“We’re interested in receiving input from across the country as the FDA begins to implement this important new authority intended to reduce the enormous toll of suffering and death caused by tobacco products in the United States,” FDA commissioner Margaret Hamburg said. “We look forward to the public’s response.”

In addition to imposing stringent new regulations on tobacco products, the Family Smoking Prevention and Tobacco Control Act creates a new office within the FDA, the Center for Tobacco Products, to oversee regulation of the industry.

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