US FDA, Advisory Committees Rarely Disagree

16 Jul 2019

• By Michael Cipriano

A Milbank Quarterly study and a Pink Sheet analysis show that disagreement between the US FDA and its advisory committee meetings doesn't happen often; it is even rarer for the agency to approve a drug against the advice from a panel.

The US Food and Drug Administration's accelerated approval of Karyopharm Therapeutics Inc.'s Xpovio (selinexor) made headlines during the past few weeks over possibility that the agency backed the drug against the advice of its Oncologic Drugs Advisory Committee.

The decision drew criticism from some in the medical community, including Oregon Health & Science University School of Medicine professor...