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F.D.A. Panel Backs Limits on Testosterone Drugs
By SABRINA TAVERNISE
SEPT. 17, 2014
HYATTSVILLE, Md. — An expert panel voted overwhelmingly on Wednesday for the Food and Drug Administration to impose strict new limitations on the multibillion-dollar testosterone drug industry, recommending that the agency tighten labels for the medicines so they are not prescribed to men who only have problems related to aging, such as low energy and libido. The F.D.A. often takes the advice of such panels.
Once used only to treat serious medical conditions, testosterone drugs are now taken by over two million American men, mostly for symptoms that are largely a result of aging, a pattern that has alarmed some medical experts. If the F.D.A. adopts the panel’s recommendations, it could sharply reduce the number of men prescribed the medicines and clamp down on marketing of them by drug companies. It could also limit coverage from insurance companies for their use, experts said.
“The whole idea is to try to rein in the inappropriate advertising and use of these drugs,” said Dr. Michael Domanski, the director of heart failure research at Mount Sinai School of Medicine, who was one of 20 members on the panel who voted to change the labeling. Just one member voted against the change.
Still, some experts were skeptical that usage would change much, because doctors can prescribe the drugs as they see fit, despite indications on the label.
One factor driving treatment is a larger number of easy-to-use testosterone drugs like gels, experts say. One of the items on the F.D.A.’s agenda for Thursday is to ask its expert panel whether it should approve a new oral testosterone drug. AbbVie, the company that makes AndroGel, a testosterone treatment, said: “Testosterone replacement therapy is an important men’s health topic. AbbVie is committed to our patients, and we will work with the F.D.A. during its review.”
Continued here http://www.nytimes.com/2014/09/18/health/testosterone-drugs-fda.html?_r=0
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This. Also im not sure those gels even work, so I guess whats the point.
By SABRINA TAVERNISE
SEPT. 17, 2014
HYATTSVILLE, Md. — An expert panel voted overwhelmingly on Wednesday for the Food and Drug Administration to impose strict new limitations on the multibillion-dollar testosterone drug industry, recommending that the agency tighten labels for the medicines so they are not prescribed to men who only have problems related to aging, such as low energy and libido. The F.D.A. often takes the advice of such panels.
Once used only to treat serious medical conditions, testosterone drugs are now taken by over two million American men, mostly for symptoms that are largely a result of aging, a pattern that has alarmed some medical experts. If the F.D.A. adopts the panel’s recommendations, it could sharply reduce the number of men prescribed the medicines and clamp down on marketing of them by drug companies. It could also limit coverage from insurance companies for their use, experts said.
“The whole idea is to try to rein in the inappropriate advertising and use of these drugs,” said Dr. Michael Domanski, the director of heart failure research at Mount Sinai School of Medicine, who was one of 20 members on the panel who voted to change the labeling. Just one member voted against the change.
Still, some experts were skeptical that usage would change much, because doctors can prescribe the drugs as they see fit, despite indications on the label.
One factor driving treatment is a larger number of easy-to-use testosterone drugs like gels, experts say. One of the items on the F.D.A.’s agenda for Thursday is to ask its expert panel whether it should approve a new oral testosterone drug. AbbVie, the company that makes AndroGel, a testosterone treatment, said: “Testosterone replacement therapy is an important men’s health topic. AbbVie is committed to our patients, and we will work with the F.D.A. during its review.”
Continued here http://www.nytimes.com/2014/09/18/health/testosterone-drugs-fda.html?_r=0
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Still, some experts were skeptical that usage would change much, because doctors can prescribe the drugs as they see fit, despite indications on the label.
This. Also im not sure those gels even work, so I guess whats the point.