Should PDUFA allow the use of user fee funding to monitor safety after new drug or biologic approval?
No. Our strong opposition to the use of user fees for postmarketing safety surveillance is based on the fact that the user fee program is not the simple transfer of funds from industry to the agency to cover part of the cost associated with the new drug approval process. Instead, to gain industry cooperation, user fees required the establishment of deadlines that have left the FDA with little flexibility. It is chilling to consider what influence might be negotiated away for allowing user fees to be expended for postmarketing safety monitoring. Would there be requirements for industry-FDA meetings to resolve disputes about whether or not the agency could release a drug safety warning to the public? Or, would the industry require negotiating its standard for causality before listing adverse drug reactions in professional and patient labeling? Both are possible if the re-authorization of PDUFA to include postmarketing safety monitoring requires negotiation with and the consent of the ind
