On November 17, 2017, KEI provided comments in KEI-FDA-2017-N-3615
These were the topics discussed:
- Clinical trial costs
- Data from the Orphan Drug program
- Costs of trials for government funded research
- Asset acquisition costs.
- Access to Knowhow, data and materials
- Non-Voluntary use/Compulsory licenses/Exceptions to Rights and Remedies
- The UACT proposal
- Extending March-in Rights
- Bayh-Dole Rights
- For products covered by insurance, reasonable incentives is a better framework than reasonable pricing alone.
- Pediatric Extension