The FDA has disagreed with the GAO's finding that the high-level management was more involved in processing this application and that the rationale offered was novel, despite acknowledging that the adolescent cognitive ability rationale was unprecedented in FDA practice.
FDAは、不完全な認識能力による根拠は、FDAの慣習に前例がないと認めたにも関わらず、GAOの高レベルの管理者がこの承認の処理により関与し、新薬という根拠を提示したという結論に反対した。