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PAT: USP vs. FDA, FDA vs. Generics?
We've been hearing more about a rift between USP and FDA on the subject of dissolution testing in particular, and process analytical technologies in general, with rumors of dissent even within FDA (these are only rumors of course---but we've heard that some old-timers at the Agency are questioning the need for ASTM's E-55 committee to be taking charge of PAT standards when USP has been setting pharma standards for so many years.)
One anonymous reader at a pharma company, unaligned with either FDA or USP, had the following, unusal perspective on the situation:
"One reason that FDA is pushing companies NOT to contribute to the USP is to [make it harder for ] generics. The FDA was held back from shutting down sub-par generics during the Reagan administration to lower the cost of drug products. They had two levels of inspection: strict for big guys, "wink and nod" for the generics."..
..."Now, if the proprietary companies use PAT, they lower their costs and become competitive with generic companies. If they don't put their methodologies into the USP, the generic companies are doomed to use outdated, expensive methods..."
The reader then went on, "I once interviewed at a generic company that was producing two different drugs, side-by-side, with only a shower curtain between them. A Ciba or Sandoz would have been shut down for that. The generic was ignored..."
Interesting....and definitely a "different" point of view. Don't most of you feel that the FDA is unabashedly "pro-generic?" And, to be fair, some generics companies are taking the lead in applying PAT. (But this explanation could certainly help explain the backlog of generic drug approvals at the Agency----as a "passive agressive" response)