The Pink Sheet reports, “Congress and the public should get an updated and extensive look at FDA performance over the next few years thanks to the many studies included in the FDA Safety and Innovation Act, although the additional work may tax agency personnel.” PDUFA V calls for more than 30 reports and studies.
That which gets measured gets done. But whose going to do the work? The FDA isn’t getting any additional funding or staffing to accomplish this important reportage – so what’s going to get prioritized?
That’s easy. Anything that is required by Congress gets done first – and that means PDUFA dates take a back seat.
More Congressional accountability for the FDA without additional funding?
Be careful what you wish for.