In memo to then-Commissioner Califf during review of Sarepta's Exondys 51, Jenkins wrote that he was concerned about leaving OND in hands of CDER director upon his retirement.

FDA’s drug center continues to operate with a staffing shortage at a time of tremendous pressure to implement new authorities. Janet Woodcock is left scrambling to find senior managers to lead top initiatives. Direct hiring authority has helped but doesn’t fully address FDA’s recruiting challenges: too much red tape and too little money.

After complete response letter, Lexicon triggers rarely used mechanism for formal hearing, prompting US FDA to publicly list its problems with the proposed type 1 diabetes drug, for which Sanofi had originally sought approval.