The Food and Drug Administration Safety and Innovation Act (FDASIA) authorized a patient-focused drug development program, and in the years since enactment, the U.S. Food and Drug Administration (FDA) has implemented certain initiatives of the patient-focused program. In recent weeks, FDA has requested feedback regarding patient-focused activities to date and recommendations about future efforts and NCCS was pleased to submit comments.

NCCS commends the FDA for including patient representatives on advisory committees and including periods of public comment but notes that the participation of the public is encouraged too late in the drug development and review process. In our comments, we advise the FDA to engage with patients earlier in the development process so it can better leverage the insights and experience of patients and patient advocates.

In addition, we commend the agency for being diligent in managing conflicts of interest to promote transparency regarding the relationships that patients and patient advocates have with product sponsors, but we are concerned that the current standards for determining conflicts of interest might block patient participation in FDA activities. We recommend a public discussion regarding the current application of the rules take place to better examine the issue.