KEI comments in FDA-2017-N-3615

On November 17, 2017, KEI provided comments in KEI-FDA-2017-N-3615

These were the topics discussed:

  1. Transparency
    1. Clinical trial costs
    2. Data from the Orphan Drug program
    3. Costs of trials for government funded research
    4. Asset acquisition costs.
    5. Licensing
    6. Access to Knowhow, data and materials
  2. Non-Voluntary use/Compulsory licenses/Exceptions to Rights and Remedies
    1. The UACT proposal
    2. Extending March-in Rights
  3. Bayh-Dole Rights
  4. For products covered by insurance, reasonable incentives is a better framework than reasonable pricing alone.
  5. Pediatric Extension
  6. Delinkage