[Ed Groleau]

Reply To: Customs Valuation of Investigational Drug Product

Yes, you should use the same valuation for every international shipment. I set the value on replacement cost, not just manufacturing. If the shipment was lost how much would it cost to repeat everything to replace it. That could be considerably more than just the cost to manufacture the drug substance. Establishing a commercial value is a different discussion with the Agency than the valuation of a research drug but under valuing it now will certainly make that conversation much more difficult when you want to set the market value at $5000/vial when you’ve been telling that country up to that point the value was much less.