FDA’s Decision To Back Off Korlym REMS Shows Context Is King
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Corcept’s NDA for the controversial agent mifepristone in Cushing’s syndrome required that FDA balance the needs of prospective patients with a severe orphan disease with the desire to preserve the drug’s REMS for abortifacient use as Mifeprex. FDA’s decision to forgo a REMS was grounded on principle, precedent, and assessment of real-world likelihood of off-label use – and vetted all the way to the CDER director.
You may also be interested in...
Can Courts And States Override FDA’s Drug Regulatory Authority?
Dueling suits seek to force US FDA to withdraw approval of mifepristone or prevent it from doing so while legislation introduced in Idaho would outlaw the use of mRNA technology. Lawyers say these are worrisome challenges to the agency's scientific judgement.
Regulatory Round-Up: Drug Review Profiles From 2012
Each month, Pharmaceutical Approvals Monthly analyzes the FDA review process for a recent approval based on the NDA or BLA review documents. A detailed chronology of product development and listing of key reviewers accompany each profile. If you do not have access, contact customer care at 1-800-332-2181 for a free copy of any of these articles.
Regulatory Round-Up: Drug Review Profiles From 2012
Each month, Pharmaceutical Approvals Monthly analyzes the FDA review process for a recent approval based on the NDA or BLA review documents. A detailed chronology of product development and listing of key reviewers accompany each profile.