• Mon news: Autolus enters CAR-T race with FDA approval. FDA clears clinical hold on Novavax. AbbVie schizophrenia trial failure. Cigna not pursuing Humana. GSK leaving BIO. See more on our front page

Biogen Hires A Lobbyist. Another Very Desperate Move.

























Yep. One of gov’t affairs’ priorities is to elevate getting CMS coverage for all FDA approved drugs as a congressional issue. As long ad they give me my severance, I don’t care what they do anymore,


Good luck getting one agency to dictate the policy of another, especially in the context of Adu. CMS is in the right and the FDA is in the wrong. Maybe we should figure out why the neuroscience head forced approval of a drug based on a surrogate marker when no Clincial benefit was established, their expert subcommittee was overwhelmingly against it, and the drug was priced like an orphan drug despite 2-3 million candidates in the Medicare patient population.
 








Good luck getting one agency to dictate the policy of another, especially in the context of Adu. CMS is in the right and the FDA is in the wrong. Maybe we should figure out why the neuroscience head forced approval of a drug based on a surrogate marker when no Clincial benefit was established, their expert subcommittee was overwhelmingly against it, and the drug was priced like an orphan drug despite 2-3 million candidates in the Medicare patient population.


It is a desperate attempt. Even still, a lawsuit will have to come from a patient and you are looking at a year or more.