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Good morning, everyone, and welcome to another busy day. The frigid weather has lifted, which means our short person has left for the local schoolhouse, the official mascots are snoozing in cozy corners and we have a moment to fire up the coffee kettle for needed cups of stimulation. Please feel free to join us. Remember that no prescription is required. On that note, here are some tidbits. Have a smashing day and do keep in touch …

The Trump administration has budgeted more than $2 billion in fees to be collected by the US Food and Drug Administration from industry in 2018, twice as much as this 2017, Reuters reports, citing budget documents. Noting a constrained budget environment, the proposed budget maintains that industries benefiting from the FDA approval process “can and should pay for their share.”

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  • If the industry is to pay 100% more, will the FDA get to increase staff to support the new process – or will the Industry be paying more while the FDA has fewer resources to deliver on it’s commitments? Given his current situation, I doubt Scott Gottlieb will be able to comment but I wonder what he’s thinking right now.

  • I believe that GDUFA fees were just renegotiated for a multi-year period, the PDUFA fees were also pre-set. Is this the ‘Art of renegotiating the BAD Deal,’ or is the Administration simply unaware that the agreements are in place? [I am constrained from suggesting ‘oblivious’ …]

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