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FDA’s Margaret Hamburg Takes On Drug Shortages

Margaret Hamburg, MD and Commissioner of FDA
Source: US Food and Drug Administration
Margaret Hamburg, MD and Commissioner of FDA

Generic drugs are in focus at Generic Pharmaceutical Association'sannual meeting in Orlando, Florida. The hot button issue: backlog of generic drug applications at the Food & Drug Administration. The number stands around 2,500. The time it takes to get a generic drug approved has nearly doubled in the past few years.

FDA’s Margaret Hamburg spoke to CNBC’s Bill Griffethin her first ever television interview after taking over as the Commissioner of the FDA in May 2009.

Addressing the delay in approval time, Hamburg says “We frankly are taking too long to review important applications, and we want to help get those products out to people who need them.”

“We've been working with the generics industry to develop a user fee program where they will actually provide resources to our drug review program to help us bring the staff on board that we need and put in place the activities that will enable us to clear up that backlog, to do the reviews in a shorter period of time,” Hamburg said.

Hamburg’s goal is to bring the median review time of generic applications from the current average of approximately 30 months—down to a primary review goal of 10 months for unamended applications.

The FDA reports generic products typically cost 50% -70% less than their brand-name counterparts. Some 80% of all retail prescriptions filled in the United States are filled with generic drugs. In the past decade alone according to the FDA, the American public collectively saved more than $931 billion because of generic drugs.

Griffeth and Dr. Hamburg also spoke about obesity as First Lady Michelle Obama looks to tackle childhood obesity rates.

Hamburg says “diet and exercise is absolutely crucial, and I think one of the things that Michelle Obama is trying to do is really try to educate people about making smarter choices about the food they eat, and particularly getting children who are at risk for excessive weight gain and obesity to start early with good eating habits and getting exercise.”

When asked if there is a company out there that could make a pill that would solve the obesity problem in this country Hamburg replied, “I think those expectations are unwarranted.”

“There will be no silver bullet. But I think we are working hard with the scientific community and with industry to figure out ways to develop quality safe and effective products to help people who are struggling with overweight and, particularly, life-threatening obesity and complications of obesity.”

Tune in:

You can watch Bill Griffeth’s interview with Margaret Hamburg today at 4:40 PM/ET on CNBC.

Lulu Chiang and Ruth Coxeter contributed to this article.

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