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FDA appoints Mary Beth Clarke as director of Office of Executive Programs

BY Alaric DeArment

SILVER SPRING, Md. — A Food and Drug Administration staffer who has led implementation of the Generic Drug User Fee Act has been named to a new director position at the agency, the FDA said Monday.

The FDA announced that it had appointed Mary Beth Clarke as permanent director of the Office of Executive Programs. Clarke had previously served as the OEP’s executive director.

FDA Center for Drug Evaluation and Research director Janet Woodcock said Clarke had spearheaded coordination of GDUFA-related activities for the center and the Office of Regulatory Affairs, including development of a project plan for human capital and infrastructure, inspections and compliance and user fee collections.

 

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Anheuser-Busch ‘Track Your Bud’ campaign features brewmasters

BY Alaric DeArment

ST. LOUIS — Anheuser-Busch is launching a new advertising campaign that lets Budweiser drinkers track where their beer comes from and how it’s made.

The campaign features fifth-generation brewmaster Pete Kraemer, as well as five regional brewmasters. Kraemer’s job is to ensure that the Budweiser brewed around the world meets the same standards; he also oversees the growing and research of barley in Colorado and hops grown in Germany. Kraemer’s father, Gerhardt, a Hungarian-born German immigrant, was also a brewmaster for the company; Gerhardt Kraemer retired in 2001.

The "Track Your Bud" television campaign, which starts Tuesday, is part of a digital campaign that allows consumers to trace the origin of their beer to one of Budweiser’s 12 breweries in the United States, look at how the beer is made and discover the source of its ingredients.

"I have to admit that I’m a little more comfortable in the brewhouse than on TV, but what I really love about this campaign is that it shows off our outstanding brewmasters, as well as where and how Budweiser is brewed," Kraemer said. "The care that goes into making our beer at all steps of the process is second to none – this app and the TV spots help showcase this."

The ads will also feature brewmasters Jim Bicklein, of St. Louis; Dan Kahn, from Cartersville, Ga.; Aaron Vaughn, from Jacksonville, Fla.; Katie Rippel, from Fort Collins, Colo.; and Dave Taylor, from Newark, N.J. The campaign will feature the company’s St. Louis flagship brewery, as well as breweries in Merrimack, N.H.; Baldwinsville, N.Y.; Newark, N.J.; Williamsburg, Va.; Cartersville, Ga.; Jacksonville, Fla.; Columbus, Ohio; Houston; Fort Collins, Colo.; Fairfield, Calif.; and Los Angeles.

 

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J&J chairman pledges to restore U.S. OTC business, outlines growth opportunities overseas

BY Michael Johnsen

NEW BRUNSWICK, N.J. — Johnson & Johnson chairman and CEO Alex Gorsky last week told shareholders that its consumer healthcare business would reclaim its prominence in the U.S. marketplace at the company’s annual shareholder meeting. But OTC growth will be greatest outside of the United States.

J&J’s consumer segment generages $14.4 billion in revenue worldwide for the company, accounting for 21% of J&J’s revenue mix. "We are absolutely committed to returning our consumer business to growth, starting first by restoring a reliable supply of our McNeil over the counter products to the market," Gorsky said. "We are also going to make targeted investments in marketing and commercial support to ensure our brands regain leadership positions over time."

Gorsky noted that over the past year J&J has made significant progress in restoring reliable supply of key products such as Children’s Tylenol and Children’s Motrin.

But the most significant growth opportunities are overseas, including Russia and Asia. For example, J&J has invested in growing and expanding its consumer business with market-specific brands such as Dr. Mom, Hot and Cold products, which appeal to consumers in Russia. Across Asia, J&J launched a green tea Listerine tailored to local tastes. 

"We also had the introduction of Listerine Essential developed for emerging middle-class consumers in Latin America and other formulations designed to meet specific regional commands," Gorsky said. 

And J&J is committing R&D dollars overseas as well. "Nicorette QuickMist, which we sell outside the United States, is a great example of innovation fulfilling a critical need," he said (GlaxoSmithKline owns the rights to the Nicorette brand name in the U.S. market). "Worldwide, over 1 billion people still use tobacco, and, on average, every 6 seconds another person dies from the effects of smoking or second-hand smoke," he said. "What if there was a product to help people quit by satisfying their nicotine craving in just a single [puff] of mist?"

 

 

 

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