"I suppose if the drug is awarded orphan drug status during development it is essentially awarded the same benefits at that time"
I think that's true....the voucher provides similar treatment for a second drug.
Of the 8 vouchers that have been issued in total, the first was used by the recipient, the second remains unused, the next 4 were sold within months of issuance and the latest 2 were issued for drugs approved within the last few months. http://priorityreviewvoucher.org/
Even though the voucher can't be used until the original drug is approved the law seems to indicate that the voucher can be issued prior to that. Nevertheless the FDA has issued the last 6 simultaneous with the approval of the drug tied to the voucher application.
I wonder if there might be some reconsideration of the voucher in the future...did they anticipate that the things could end up getting sold for $350 million? That $350 million is being used by a big pharma to get a competitive leg up. The incentive purpose of the program clearly worked and is working, but that $350 million will need to be recovered from the pockets of those who pay for health care...at some point that means us. Do I have to point out that it's a lot of money?
This unsourced quote has been provided in an earlier post: "The 21st Century Cures Act (H.R. 6), passed by the House of Representatives on 7/10/2015 includes a provision to reauthorize the RPD PRV Incentive Program through 12/31/2018."
That's true. This isn't: "Apparently the program has been extended to 2018"
The Senate has yet to pass its version of the bill.