It looks like CMS is making its restrictive coverage policy on Aranesp and Procrit stick. That is a big hit to Amgen and J&J. It is also an important precedent for other manufacturers: CMS is demonstrating that it can deny coverage based on the absence of evidence-even when the therapy is the standard of care.
Michael McCaughan
Show me the data.
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The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.
The reductions across medical product programs in the agency’s budget request include hundreds of positions funded by user fees, which may foreshadow its upcoming user fee restructuring strategy.
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
