Preapproval Contracting

Interested to get other peoples views or input on how companies have traditionally managed the timing of either a brand or a generic contracting initiative before a products formal FDA approval as either an NDA or ANDA. Appears to be a wide difference in opinion as to safe harbors, forward contracts, or pre-launch payer engagement initiatives.

 

Generic is an already approved NDA, so forward contracts within a B2B context can be negotiated pending ANDA approval. No clinical or promotional discussions.

 

Gray area as by statute, ANDA not approved, so could be considered out of label discussion. Assuming no mention of indication or other claim, just compound and price, could be OK. I think most wait for ANDA or FDA approval before engagement.

 

Its a supply agreement for an already approved compound. Future contract pending ANDA approval of sameness.

 

CRF statute involving Off Label promotion relates to product advertising to HCP's or patients pre-approval. Payers or Distributors are neither.