The US Medicare Payment Advisory Commission is continuing its work on proposals to overhaul federal payment for physician administered drugs. That is an ominous message for the biopharma industry as it reels from passage of dramatic pricing legislation earlier this year.

President Biden’s informal declaration that the COVID-19 pandemic is ‘over’ likely portends a formal end of the Public Health Emergency. But many of the US FDA’s COVID flexibilities don’t directly depend on that decision.

The White House ‘Biotechnology’ initiative is very broadly focused, with non-health sectors receiving the bulk of the attention. The US FDA’s role is small – but it could further boost attention to efforts to encourage adoption of advanced manufacturing.

The White House is playing up a new initiative to support ‘biotechnology and biomanufacturing.’ The focus on innovation is always a welcome theme – but it does not signal any change in the emphasis on cutting drug pricing in the Biden Administration.

Everyone knows that cancer drugs dominate use of the Accelerated Approval pathway by the US FDA. But it is remarkable just how rare a non-cancer AA is.

Republican Congressional letter asking HHS nuts-and-bolts questions about the newly enacted drug price ‘negotiation’ law points to a much more fundamental issue: can a bureaucratic agency make the program work in a manner that appears credible and free of undue political interference?