Obtaining data on cost of FDA drug approval process

To follow up on the post describing Investment Model for Pharma…   We’re working on obtaining data on cost of FDA drug approval process via DDOD (Demand-Driven Open Data).  Use Case 34: Cost of drug approval process describes this effort.  It identifies the drivers and value of obtaining this data in informing policy.  The writeup identifies several data sources and how to go about using them.  The information provided has come from discussions with FDA’s CDER Office of Strategic Programs (OSP).

Data sources identified:

  • IND activity: Distinct count of new INDs (Investigational New Drug) received during the calendar year and previously received INDs which had an incoming document during the same period: INDs with Activity page
  • PDUFA reports: The Prescription Drug User Fee Act (PDUFA) requires FDA to submit two annual reports to the President and the Congress for each fiscal year: 1) a performance report and 2) a financial report
  • FTE reports: Statistics on number of FDA employees and grade levels
  • ClinicalTrials.gov might provide glimpses into drug approval activity, although it’s not complete (especially for Phase 1 trials) and mixes in non-IND trials.
  • Citeline has counts of active compounds under development, including breakdown by Phase

As more users come forward to identify specifics of how they need to use the data, there’s an opportunity to refine the use case and focus efforts on obtaining data not yet available.

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