Posted by Roger Bate
As I argue in a piece on RealClearPolicy.com today, the FDA is being far too aggressive in its condemnation of a small but important piece of research conducted by Harvard’s Preston Mason. At the root of the problem is the dirty little secret of the FDA. They don’t really test the approved medicines on the market in the US. FDA pays a great deal of attention to approving new products, and in conducting inspections of plants for existing products. But it probably only tests a few hundred samples of products on the US market every year. It relies on the honor system - once it has established that a company can produce a medicine properly, the assumption is that it always will. But anecdotal evidence from US doctors, and systematic evidence of fraud from some exporting companies to US, indicates that perhaps the system is broken. Rather than sober reflection and more random drug sampling to establish how bad the problem might be, the FDA is lashing out at anyone who dares to say the generic drug emperor might be missing some clothes. This could be the beginning of a very ugly fight.