On the recordJune 24, 1998
First of all, the department is much more knowledgeable than my colleague might give them credit for. They understand what drugs are used for, and they are scientists and very good at what they do. And if, in fact, some company is making application for a drug that the primary purpose is for something that fits the charge of the FDA, consumer safety, not death, not killing, but consumer safety, then I think they have very well the ability to figure out what the purpose of that application is. And they also have to very clearly state in their NDA what the purpose is for the drug.
Source
govinfo.gov




