Is FDA too lax with its drug ap­proval stan­dards? Se­nior FDA of­fi­cials dis­cuss

From in­dus­try to acad­e­mia, com­menters have ar­gued that the FDA drug ap­proval stan­dards are be­com­ing in­ap­pro­pri­ate­ly low and that the re­quired postap­proval eval­u­a­tions are ei­ther in­ad­e­quate or left un­done.

But three se­nior FDA of­fi­cials of­fered sev­er­al coun­ter­points on Mon­day at the fifth an­nu­al Bio­phar­ma Con­gress in Wash­ing­ton, DC.

Janet Wood­cock, di­rec­tor of the FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search, ex­plained that the agency is work­ing on its own analy­ses to pro­vide “a more ro­bust re­sponse” to these cri­tiques. She al­so ex­plained how the high num­ber of ap­provals in re­cent years for rare dis­eases may be in­flu­enc­ing this per­cep­tion of a low­er bar, es­pe­cial­ly as more treat­ments are ap­proved on the ba­sis of a sin­gle-arm study or with an ex­ter­nal con­trol group. In ad­di­tion, she point­ed to the “as­tound­ing­ly” high launch prices for some of these rare dis­ease treat­ments that may al­so be part of the rea­son for the push­back.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER