Top FDA of­fi­cial ac­cused CDER chief Wood­cock of ap­pear­ing bi­ased, brow­beat­ing re­view­ers in de­mand­ing eteplirsen OK

While FDA com­mis­sion­er Rob Califf was try­ing to nav­i­gate an in­ter­nal civ­il war at the agency over its con­tro­ver­sial de­ci­sion to pro­vide an ac­cel­er­at­ed ap­proval for Sarep­ta’s eteplirsen, John Jenk­ins, then head of the Of­fice of New Drugs, sent him a memo which de­tailed a blis­ter­ing at­tack on CDER chief Janet Wood­cock.

It was Wood­cock who de­mand­ed, and won, the ar­gu­ment in fa­vor of an ac­cel­er­at­ed OK of the Duchenne mus­cu­lar dy­s­tro­phy drug.

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