FDA’s OCP Works to Modernize Review Functions
Modernized regulatory review functions for drugs and biologics applications were implemented at the US Food and Drug Administration’s (FDA) Office of Clinical Pharmacology (OCP) in 2018 and will be used to prepare for 2019 priority areas related to the opioid crisis, antimicrobial resistance and rare diseases.OCP, within the Center for Drug Evaluation and Research (CDER), outlined newly implemented steps for modernizing review functions in its recently released annual report that also offered a recap of 2018. The report further provided OCP’s outlook and priorities for 2019 and was issued in conjunction with an annual report from OCP’s Division of Applied Regulatory Science (DARS).
OCP said its modernized regulatory review processes and new analytical approaches helped to optimize dosing recommendations, quantify risk, develop management strategies to mitigate those risks and guide patient selection for treatment.
Modernization also addressed labeling reviews. OCP implemented an integrated labeling review process, as discussed in its 2017 annual report and its MAPP, for new drug applications and original biologics license applications. This review process seeks to “create consistency in describing clinical pharmacology information” in prescription drug labeling, OCP said.
DARS, meanwhile, co-authored a new “teach tool” during 2018 for reviewers to evaluate applicants’ (Quantitative) Structure Activity Relationship data. It is now exploring new computational modeling methods and statistical approaches to estimate risks of outcomes in demographic subgroups.
Technology, tools and standards topped the list at 22% of priority focus areas for OCP working groups and committees in 2018, followed by general drug development topics (16%), regulatory policy (15%), as well as product, class and therapeutic-specific domains (15%).
Moving forward, OCP said its “important areas of focus” in 2019 “will include current health issues related to the opioid epidemic, antimicrobial resistance and rare diseases.” In addition, the office will retain some of its previous work focus areas. These relate to the role of applying pharmacogenomic information in clinical trial designs and therapeutic optimization and advancing biosimilar development.
OCP anticipates more reviews of drug applications related to model-informed drug development (MIDD) this year and intends to dedicate the necessary resources to accommodate the increased demand. It also plans to host a series of MIDD workshops and educational events throughout the year.
OCP report, DARS report