It seems to me that the best way, and most direct way, for the FDA to defend itself in this matter is to make public the deficiencies in Teva's application. The FDA does not normally issue rejection letters for ANDAs, but it can do as it did with the immunogenicity issues in 2008, and issue a letter indicating the defects. Teva can then pervert the press to argue that "chemical sameness" is all that should be necessary for any generic, no matter how complex, except for Copaxone, which is of course a special case drug, that can only have a generic with clinical trials.
It is speculation, but from an institutional perspective you resolve the issue of the bureacratic nightmare that Teva is complaining about, and fully inform the world as to why Teva's application was not approved, and it had nothing to do with MNTA assisting in an emergency to save lives that no one else in the world was qualified to assist in saving.
Institutionally, that seems like the appropriate response. But that is just speculation, but would be something the FDA could do to create more "transparency" in its decision making, and to reduce the time that companies are left waiting in bureacratic limbo, particularly when an ANDA clearly falls short of the standards set.
It is a much better solution than the FDA arbitrarily and capriciously approving one directly substitutable generic on one standard and then on no new science or information approving other directly substitutable generics by a lessor standard.
I think in any event, the chances of actually getting information out of the FDA indicating a rejection are greater after this attack on the FDA than it was before the attack.
Tinker
AI
