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Latest From Michael McCaughan
Correvio’s attempt to move vernakalant from 'clinical hold' to 'FDA approved' was a huge long shot. But the advisory committee vote – and looming FDA rejection – are another indication that real-world data is not a panacea.
White House Council of Economic Advisors says US House drug price “negotiation” bill will reduce the number of innovative medicines by 100 over a decade; the Congressional Budget Office says more like 8-15. Both analyses miss the point – but also show that industry is losing a crucial piece of political ground.
The FDA has confirmed the picks to head most of the new offices in the restructured drug review organization, with one notable exception. The choice for the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine is still pending, while one candidate – Hylton Joffe – will be serving as acting OND deputy director.
Correvio’s anti-arrhythmic vernakalant is returning to an advisory committee a dozen years after its first review, continuing a recent pattern of return visits for applications – and 12 years isn’t even close to the longest long back for US FDA panel in 2019.
Stephen Hahn mostly coasted through a confirmation hearing to be the next FDA commissioner – but he still didn’t really give any indication of why he wants the job.
CMS streamlined process for enhanced payments is having an impact: seven antibiotic applications for New Technology Add-On Payment status in 2021—including one for a product that has been marketed for more than five years.