Apparently the Bariatric doctors are very upset with the latest FDA action. This is the third drug the FDA has turned down in the last year.
One doctor has taken his displeasure to the extreme. It will be interesting to see if he remains on the FDA committee. He states quite bitterly - "I think it does send a very bad message to the drug companies who invested billions of dollars in the drugs and have tried to follow the rules the FDA laid out, and yet when they show up with the data they're rejected,"
Then he went on to say, "We also think it sends a very bad message to patients as well. It says, 'Don't expect any help from the FDA, and don't expect any new medicines, so you better go see the quacks in your neighborhood, because that's all you're going to get."
I am very happy that I do not know this doctor. His actions just reinforce why we are so distrustful of the FDA. We do need good doctors on the FDA committees and in other positions, but when they are overly vocal, maybe it is time for them to resign.
I am just thankful that the FDA has chosen to ask for more trials and data. This is their duty and too many drugs have been allowed that maybe never should have been allowed to pass.
Read the article here.
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