Skip to Main Content
Contribute Try STAT+ Today

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.”

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!


What is it?

STAT+ is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.

What's included?

  • Daily reporting and analysis
  • The most comprehensive industry coverage from a powerhouse team of reporters
  • Subscriber-only newsletters
  • Daily newsletters to brief you on the most important industry news of the day
  • STAT+ Conversations
  • Weekly opportunities to engage with our reporters and leading industry experts in live video conversations
  • Exclusive industry events
  • Premium access to subscriber-only networking events around the country
  • The best reporters in the industry
  • The most trusted and well-connected newsroom in the health care industry
  • And much more
  • Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.
  • 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’ …]

Comments are closed.