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Preapproval Contracting

Discussion in 'Managed Care Specialists - General Discussion' started by Anonymous, Jun 6, 2015 at 1:04 PM.

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  1. Anonymous

    Anonymous Guest

    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.
     

  2. Anonymous

    Anonymous Guest

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

    Anonymous Guest

    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.
     
  4. anonymous

    anonymous Guest

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

    anonymous Guest

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