By NextBestFitTask 1.9.4 of 7
Define the §1498 process: if a manufacturer won't sign a price within 18 months, the Board may contract for generic supply and pay the patent holder 'reasonable and entire compensation' set by the Court of Federal Claims.
Who does it
Formulary Board / DOJ
When
Month 12
Trade-off
A §1498 backstop strengthens bargaining but risks trade retaliation and fewer future launches.
Part of: Create the national formulary & negotiate drug prices
A National Formulary and Pricing Board covers every FDA-approved drug with a negotiated price. Retail drug spending falls from $467.0B to $380.1B (price effect −$113.1B, utilization +$26.2B).
This step changes 10 existing laws, programs, or institutions. See the list.