Most know that when a 505(b)(2) contains the results of a clinical study other than a bioequivalence study, the application will be assessed a full PDUFA user fee. However, did you know that if you file a 505(b)(2) application that relies on published clinical studies, your application may also be subject to the full fee? It appears that FDA may be revising its statutory interpretation such that if there is a need to review underlying clinical data, even if it is from published literature, rather than just relying on previous Agency findings of safety or effectiveness you may need to pay the “full monty”. It is not known if the FDA is going to formalize this policy any time soon, but take care when submitting a (b)(2) and discuss the fee implications of your submission with the review Division to determine if you need to submit with the higher fee.
While this makes sense, since the FDA must review underlying clinical data upon which the applicant is relying, the fact is that a number of (b)(2) NDAs submitted in previous years may have skirted by with a half fee. Just note that FDA is becoming more diligent about their assessment practice in this regard and make sure your bank account has sufficient funds!