The US Food and Drug Administration (FDA) on Monday released a manual of policies and procedures (MAPP) outlining how its Center for Drug Evaluation and Research (CDER) staff consult with Controlled Substance Staff (CSS) on abuse potential and dependence liability.
Since 2000, CDER and CSS, which fulfills a unique role within FDA under the authority of the Controlled Substances Act (CSA) of 1970, have collaborated to evaluate all new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs) and investigational new drug (IND) applications submitted for any treatment that has a stimulant, depressant or hallucinogenic effect on the central nervous system, all of which “are signals indicating that the drug may have abuse potential,” the MAPP says.
On the IND side, CSS looks into information relating to the potential for abuse and dependence in clinical studies, via an evaluation of the methodology and data in a nonclinical or clinical protocol or study report. From this information, CSS determines whether a drug under review requires additional nonclinical or clinical studies designed to address questions about the abuse potential of the drug.
CSS conducts additional scientific and medical evaluations to determine if a drug warrants control under the CSA, and thus scheduling recommendations.
When necessary, CSS drafts scheduling recommendations, which the MAPP says proceed through a clearance process that includes CDER’s Office of the Center Director, FDA’s Office of the Commissioner and the Office of the Assistant Secretary for Health (OASH) at HHS. Scheduling recommendations from HHS are ultimately transmitted to the Drug Enforcement Administration (DEA), though CSS makes recommendations on labeling to the consulting FDA office or division consistent with the scheduling recommendation and the drug’s abuse and dependence liabilities.
CDER offices and divisions are also tasked with notifying CSS promptly when a consultation involves INDs and information regarding the study of abuse, dependence and scheduling needs to be conveyed.
For INDs, NDAs, BLAs and ANDAs, CDER provides the desired completion date and justification for the date in the consult, including the user fee goal date, pertinent internal or industry meetings, Advisory Committee (AC) meetings and meetings with other groups.
The MAPP notes that CSS generally needs 30 days to prepare for industry meetings, to perform IND reviews and to prepare for filing meetings, though consultations on NDAs, scheduling actions and abuse-related risk management issues require longer preparation times.
MAPP 4200.3 Rev. 1