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FDA has collected more than $255 million in generic drug user fees

BY Alaric DeArment

NEW YORK — The Food and Drug Administration’s Center for Drug Evaluation and Research has collected 84% of the fees it intends to collect this year under a law passed last year to collect user fees from generic drug members, according to a memo sent out to CDER staff Tuesday.

CDER director Janet Woodcock wrote that the FDA had collected more than $255 million under the Generic Drug User Fee Amendments to the 2012 Prescription Drug User Fee Act reauthorization. The agency plans to collect $299 million in fiscal year 2013.

In addition, the agency has hired 165 new CDER staff members, helped to make it easier to accurately calculate fees and made "significant strides" in reducing the backlog of generic drug approval applications.

"As we approach the one-year anniversary of the Generic Drug User Fee Amendments of 2012 (GDUFA), I would like to recognize the important accomplishments of those who have worked to launch this program," Woodcock wrote. "This has been a cross-cutting Center and Agency-wide effort led by Mary Beth Clarke, and involving staff and managers from the Office of Regulatory Affairs and most of CDER’s offices."

Woodcock wrote that the program would transition to a new project and governance structure similar to PDUFA, led by a new steering committee and focusing on enhancing the program and transforming the generic drug application review process.

 

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Eat Well, Test Well: Bayer HealthCare and dLife Healthcare Solutions launch diabetes resource

BY Jason Owen

TARRYTOWN, N.Y., and WESTPORT, Conn. — Bayer HealthCare, makers of the Contour Next portfolio of blood-glucose meters, and dLife Healthcare Solutions, a diabetes behavior change solution, have created and are working together to offer Eat Well, Test Well, a six-week food and nutrition program for people with diabetes. The Eat Well, Test Well program is available online at no charge and was developed to help educate and motivate people with diabetes to make healthier mealtime choices based on the results of blood-sugar testing as a guide.

According to a January 2013 dLife/dQ&A study of more than 1,300 people with Type 2 diabetes, more than 85% of respondents said they have tried to make major changes in their food choices one or more times in the last 3 years to better manage their diabetes, yet only one quarter report having stayed on their plan consistently. When asked what would motivate them to change their eating habits, the top two motivators were experiencing more diabetic complications (92%) or blood-glucose testing results were too high (88%).

The online program is based on a clinically proven model that organizes information into six weekly themes, including carb counting, portion control, the impact of food on blood glucose numbers, and more — designed to help reduce the frustration and stress that may come with making healthy mealtime decisions. The Eat Well, Test Well program offers members support through weekly e-newsletters, as well as articles, videos, recipes and quizzes — all within a personalized website experience. After completing the program, members should have the knowledge and confidence they need to make better food choices for their own diabetes management.

To encourage enrollment, Bayer HealthCare is offering a Contour Next or Contour Next USB blood-glucose meter to every enrollee at no charge. Bayer meters include features, such as auto-log technology which prompts users to test regularly and track blood-glucose numbers in conjunction with mealtimes — enabling them to better understand how their personal food choices impact their blood-glucose numbers.

"Bayer HealthCare is continually bringing innovation to blood-glucose testing, and the Contour Next portfolio of meters with Meal Marker technology provides a simple and smart way for people to test and track at those crucial mealtimes," said Dr. Brian Pflug, global medical affairs, Bayer HealthCare. "By partnering with a leader in diabetes lifestyle management like dLife, we believe we bring the technology and education together for our customers to have a meaningful and lasting improvement in their diabetes nutrition and blood-glucose control."

According to Sean Foster, CEO, dLife, "Food is a critical factor in blood-sugar highs and lows, and for those trying to manage their diabetes for good control, meal time can be an overwhelming and burdensome event. We’re hoping that simple nutritional education, coupled with state-of-the-art Contour Next BG meters from Bayer, will help people take control of their mealtimes and make smarter choices — ultimately bringing more ease and joy into their daily lives."

The Eat Well, Test Well Program is available to all people trying to actively manage their diabetes. Enrollees can register at www.eatwell-testwell.com.


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Royalty Pharma drops bid for Elan Corp.

BY Alaric DeArment

NEW YORK — Royalty Pharma will not buy Irish drug maker Elan Corp., the company said Tuesday.

Royalty said it would withdraw a request for a review by the Irish Takeover Panel after Elan shareholders voted in favor of a share buyback. Elan said last week that it would begin a process of selling itself to Royalty, which had previously offered $13 per share for the company.

Royalty, based in New York, invests in royalty interests in drugs already on the market and undergoing late-stage clinical trials. Its portfolio includes 80% of Memorial Sloan-Kettering Cancer Center’s royalty on Amgen’s Neupogen (filgrastim) and Neulasta (pegfilgrastim), for which it paid $400 million, and the AstraZeneca’s royalties on AbbVie’s drug Humira (adalimumab), which it bought for $700 million.

 

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