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FDA exceeds FY2013 GDUFA hiring goals

BY Alaric DeArment

SILVER SPRINGS, Md. — The Food and Drug Administration has exceeded its goals for hiring new staff as part of a user-fee law for generic drugs, according to an internal memo sent to staff members.

In a memo to staff of the agency’s Center for Drug Evaluation and Research, center director Janet Woodcock wrote that for fiscal year 2013, the FDA hired 234 people as part of the Generic Drug User Fee Amendments Human Capital Team. The goal was to hire 231 as part of a three-year push in which it hopes to hire 921, including 461 during fiscal year 2014.

"I am extremely happy with this accomplishment," Woodcock wrote. "As hiring continues through the end of this fiscal year, planning has already begun for next fiscal year."

The amendments, known as GDUFA, were passed last year as part of the renewal of the Prescription Drug User Fee Act. The agency is using money raised from generic drug company user fees to reduce its backlog of generic drug approval applications.

 

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Jelly Belly continues support of U.S. veterans, launches camouflage jelly beans

BY Jason Owen

FAIRFIELD, Calif. — On Tuesday, Jelly Belly Candy Co. introduced new Camo Beans, a special selection of jelly beans inspired by the art of camouflage, as well as a new support initiative for military families.

Jelly Belly Camo Beans come in 3.5-oz. bags in 12-ct. cases and come with seven flavors inside each bag: chocolate pudding, green apple, licorice, juicy pear, orange sherbet, toasted marshmallow and watermelon.

As part of the company’s initiative to continue supporting U.S. troops, for every bag of Camo Beans sold, Jelly Belly will donate $0.25 in support of U.S. veterans and their families.

Camo Beans became available to ship in August. Jelly Belly jelly beans are certified OU Kosher and are free of gelatin, gluten, fat and dairy.


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Report: Sugar accounts for 17% of normal U.S. diet as Type 2 diabetes accounts for $500 billion in global healthcare spending

BY Alaric DeArment

NEW YORK — Nearly all doctors say that the sharp growth in Type 2 diabetes around the world and the obesity epidemic are linked to excess sugar consumption, according to a new report by the Credit Suisse Research Institute.

The institute, part of the global investment bank, released the report Wednesday titled "Sugar: Consumption at a Crossroads," which explores the medical, economic, consumer, corporate and public policy elements of global sugar consumption and what it means for investors.

The report includes a survey of doctors in the United States, Europe and Asia, which found that 90% think that people consuming too much sugar is strongly linked to the growth in diabetes and obesity. The United States, Brazil, Argentina, Australia and Mexico were found to lead global sugar consumption, and added sugars represent 17% of a normal U.S. diet, with more than 40% of added sugars coming from sweetened beverages. In addition, the report found that Type 2 diabetes was growing at 4% per year, and obesity was growing at 1-2%; in 2012, 4.8 million people around the world died of diabetes, compared with 5.6 million who died from illnesses related to smoking, and over 10% of global healthcare spending — totaling $500 billion — went to Type 2 diabetes.

"Although causality is difficult to prove in this area, with such a high percentage of doctors in our proprietary survey confident of this strong link, we cannot ignore the significance and the implications for society and our economy," Stefano Natella, a Credit Suisse research and study author said.

The report looked at the possibility of taxation, saying it was possibly the most effective way to curb consumption, but was less likely to succeed in most places. But the risk of public intervention and awareness would likely force companies to adapt as consumers move toward healthier options that use high-intensity natural sweeteners.


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P.PEEKE says:
Sep-12-2013 01:53 pm

Added and highly processed sugars are certainly an enormous contributing factor to the development of Type 2 diabetes as well as other serious illnesses. I think, however, many of my readers and patients will wonder at this story in the context of their next visit to their local drug store where they probably have to walk a gauntlet of sweet treats and Halloween candy in order to get to the pharmacist in the back of the store.

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