Plenty of people believe the US FDA should never have approved Biogen/Eisai’s Alzheimer’s therapy. But does that really mean it is okay for the Medicare agency to decide as a matter of policy that the drug has not been proven safe and effective?

The Democratic party has been advocating for Medicare drug price negotiation authority in the US for almost two decades. The coming year may see it finally happen – or it might mean the issue is gone for good.

FDA’s use of advisory committees is at a historic low – as are the prospects of sponsors getting a positive outcome. Is it COVID? Or a more fundamental shift in how FDA uses its panels?

Is there anything less satisfying than a confirmation hearing for US FDA commissioner? Robert Califf performed very well during his testimony to return to the post, but no one who follows FDA closely likely learned much they did not already know.

Is there anything less satisfying than a confirmation hearing for US FDA commissioner? Robert Califf performed very well during his testimony to return to the post, but no one who follows FDA closely likely learned much they did not already know.

No one thinks it is a good idea for the US FDA Commissioner or some other higher up political actor to decide when and if to approve new drug applications. But it might not be so bad if the scientific staff at FDA paid a bit more attention to ‘political’ issues before making some decisions.