Friday, August 03, 2012 3:41:28 PM
Moreover, the FDA’s raison d’etre has never been to approve generic-drug applications as quickly and easily as possible. Such an assertion would be met by laughter if repeated to executives at TEVA, MYL, and WPI.
You are mistaking the opinion of a user of a bureaucracy with the self opinion of the bureaucrat. There is a HUGE difference.
E.g. I agree that Teva et al would say that the FDA is inept at getting things approved easily and quickly. But if you talked to the FDA personnel working in the generics approval groups I'd bet 100:1 they would list among their chief personal goals 'facilitating approval of as many generics as possible' in their top 5 list along with 'make sure it really is substitutible (same SAE and efficacy in same patients.)'
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