Preclinical assessment of abuse liability of biologics: In defense of current regulatory control policies

摘要: Current regulatory policies of both the US Food and Drug Administration Enforcement do not delineate automatic exceptions for biologics with respect to preclinical assessments abuse liability all new entities. As defined in current guidance documents drug control policies, an exception may be given upon thorough review available data, therapeutic target consultation Controlled Substances Staff within Center Evaluation Research FDA, but a blanket biological entities is currently available. We testing four known definitive positive signals three core assays, self-administration, discrimination, dependence potential described FDA draft document. Interestingly, while examplars have two these are controlled under Comprehensive Abuse Control Act (CSA, 1970) other controlled. Admittedly, small molecule However, there no reference "molecular size" legally-binding statutory definition FD&C act or Act. Neither policy mandates bifurcated status which make based solely on molecular size. With pharmaceutical focus technologies, such as "Trojan Horses", targeting active transport large directly into CNS, argument automatically exempt size untenable. argue that safety health general public maintained until criteria can identified amended FD&CA CSA, if warranted.