Patient Advocacy With FDA Review Staff Will Be Tougher Post-Sarepta
Efforts by CDER management to encourage more interaction between patients and FDA reviewers may be part of the collateral damage from the difficult FDA review of Sarepta’s Exondys 51. The hopes of parents of boys with DMD pushed the regulatory flexibility by CDER management on this application – but may end up limiting the willingness of FDA reviewers to engage with patients in the future.
You may also be interested in...
Patient advocates asked what they could do after US FDA’s complete response letter for the proposed Duchenne drug, but Sarepta's CEO said the company would get the product back on track to approval itself, a marked contrast to engaged role the community played the last time the firm ran into a roadblock at the agency.
After conducting 24 disease-focused meetings in five years, FDA moving to next phase of patient interaction under new user fee cycle.
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.