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Did FDA Foot-Dragging Delay New Diet Pill Approval?

By    |   Friday, 19 September 2014 05:24 PM

The Food and Drug Administration's approval of a new weight-loss drug this month marked the third time the agency has OK’d a new diet medication since 2012.
Called Contrave, the medication is a combination of two approved drugs: naltrexone, which treats alcohol and drug addiction, and bupropion, which treats depression and is used to help smokers quit.
But medical entrepreneur Joseph V. Gulfo, M.D. tells Newsmax Health the agency should have approved the drug in 2011, when it had all the evidence it needed that the medication is not only effective, but also safe. In an exclusive interview airing on Newsmax TV's Meet the Doctors program, Dr. Gulfo argues the FDA’s delayed action on Contrave is only the latest to indicate that effective new treatments being kept from American consumers because government red tape has tied the agency’s hands.
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“Contrave should have been approved 3.5 years ago because they had positive FDA panel of experts who voted 13 to 7 in favor of the drug, but he FDA rejected it,” says Dr. Gulfo, author of “Innovation Breakdown: How the FDA and Wall Street Cripple Medical Advances.” He adds: “This poor company got victimized … and that’s what it’s really all about: [the need to] get drugs that are safe and effective in the hands of the doctors.”
On Meet the Doctors, endocrinologist Rachel Pessah-Pollack, M.D., also suggests the new medicine holds great promise for people who combine its use with regular exercise and a reduced-calorie diet.
The FDA said in a news release that Contrave can be used by obese adults and by overweight adults who have at least one other weight-related condition or illness, such as high blood pressure or Type 2 diabetes.
According to the U.S. Centers for Disease Control and Prevention, more than one-third of adults in the United States are obese, the FDA said in its news release.

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To view a complete report on the new diet drug, and other health news, tune in Saturday, Sept. 20, at 7 and 11 a.m. (E.S.T.) to Newsmax TV’s Meet the Doctors program, at NewsmaxTV.com, or DIRECTV Ch. 349 and DISH Ch. 223.

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The FDA's approval of the new diet pill Contrave could have come more than three years ago, an agency critic argues.
fda, foot, dragging, drugs, contrave, diet, pill
Friday, 19 September 2014 05:24 PM
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