Biotech Values

[DewDiligence]

Marth was trying to convince listeners that the involvement of OBP means sameness has been established and hence the review of the ANDA by the Office of Generic Drugs (OGD) is complete; however, I don’t think Marth’s logic stands up to scrutiny because the interaction between OGD and OBP is more of a back-and-forth thing than a sequential process.

Bill Marth himself is on record that the interaction between OGD and OBP is back and forth; this is what Marth said at the Goldman Sachs investor conference on January 8, 2009 (#msg-35090820):

There isn’t a good way today of handling these products within the Agency if you follow the flow of what goes on… We submit… eventually we get accepted [for review]… once we get the acceptance, there’s a series of questions… we answer those questions… the answers go into OGD [Office of Generic Drugs]… OGD looks at it, throws it over to Office of New Drugs [i.e. OBP within CDER] for a consult… New Drugs says, “There’s no PDUFA fee so I’ll put it over here”… they eventually get to it… they answer it… they send it back to OGD… OGD may have further questions for New Drugs… they send it back to New Drugs… then it eventually comes back to us for a response and the whole cycle starts again.”

I rest my case.