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Friday, 08/09/2019 7:38:29 AM

Friday, August 09, 2019 7:38:29 AM

Post# of 430286
I Remember back in 1994 the FDA told my company to stop the promotion of a product that they had approved. We had been selling it for 6 months and the uptake was outstanding. Then one day the FDA came to us and said to stop the promotion of the product. Reason? They said documentation pertaining to a CMC letter was not in their file. CMC - Chemical, manufacturing and control. We had come to learn that there were some important clinicians out of the North East (major institution) that had it out for our small company and drug. The FDA refused to meet with us. It was our only real drug at that time. We were on the verge of shutting down completely. At the time we were a private company. We didn’t fold. We went to congress and the senate and got their help to get the FDA to talk with us and they did. Gingrich, McConnell and Grassley were instrumental with getting the FDA to come to the table. In the end it all got worked out. The drug was Adderall. the most successful ADHD drug of all time.

My point? We fight!!!!
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