Phase 1: Enactment & build · Step 1.9
Create the national formulary & negotiate drug prices
Months 0–18 for the initial formulary; continuous negotiation · National Formulary and Pricing Board; HTA InstituteDiscuss this step
marketlikelihood: mediumimpact: medium
Larger-than-expected drop in drug innovation
Lower U.S. prices reduce global R&D investment more than CBO-style estimates predict.
Early warning signs
- Venture funding for biotech
- Phase I trial starts
- U.S. launch delays
Mitigation
- Value-based pricing that rewards breakthroughs
- Increase NIH/BARDA funding
Implementation risks
| Risk | Mitigation |
|---|---|
| Manufacturers withdraw drugs from the U.S. market. | §1498 authority; the U.S. is about 45% of global pharma revenue, so withdrawal is costly for manufacturers. |
| Trade retaliation or treaty disputes over §1498. | Use §1498 sparingly as a backstop; TRIPS Article 31 permits government use with compensation. |