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FDA’s OCP 2020 report highlights achievements post-reorganization

Posted 23 February 2021 | By Jeff Craven 

FDA’s OCP 2020 report highlights achievements post-reorganization

The US Food and Drug Administration’s (FDA’s) Office of Clinical Pharmacology has issued its 2020 report, highlighting the office’s contributions to drug development, research, policy and communication.
Describing the COVID-19 pandemic as the “personal and professional challenge of a lifetime,” Issam Zineh, PharmD, MPH, Director of the Office of Clinical Pharmacology (OCP), said OCP staff met the moment during a global public health crisis by creating “strike teams to address scientific and regulatory issues related to the pandemic.
“Internally, we established multiple, new methods to communicate the latest research, ensuring that our staffers had the necessary data and tools to make the most informed regulatory decisions,” Zineh wrote in a director’s address preceding the annual report.
OCP, which is itself an office within the FDA Center for Drug Evaluation and Research (CDER) Office of Translational Sciences, was recently part of a larger reorganization effort in CDER to modernize the New Drugs Regulatory Program. That reorganization, now complete, also saw OCP expand to 8 review divisions, adding a new Lifecycle Management program and Strategic Communications Team. “Our continued efforts at organizational excellence ensure better review quality and process efficiency, with a vision towards serving patients by delivering safe, effective, and high-quality drugs,” the authors of the report stated.
For 2020, OCP published six new guidances for industry and 18 internal policy briefs as part of its policy fellowship program, with the majority of the guidances focusing on study design, conduct and interpretation of drug-drug interactions. OCP staff also participated in more than 58 guidance and policy working groups, where the office provided perspective on “a diverse array of diseases, drugs, devices, and biological products” to inform FDA’s work on product guidances, internal policy briefs and other documents, according to the annual report.
Zineh noted that OCP “met or exceeded our organizational, scientific, and regulatory goals for 2020,” with the office contributing evaluations for 53 new drug applications (NDAs), NDA supplements, biologics license applications (BLAs), and 351(k) applications brought to market. In addition, OCP conducted 2,660 Investigational New Drug (IND) reviews and 1,680 IND meetings, and contributed to 7 advisory committee meetings.
OCP also provided an update on its Model-Informed Drug Development (MIDD) Pilot Program, which allows sponsors and FDA to discuss modeling and simulation issues during development. In 2020, there were 36 sponsor meetings and 92 internal meetings, an increase from the 22 sponsor meetings and 50 internal meetings held in 2019. The MIDD program “brought together thought leaders from across the Agency to facilitate drug development through the use of novel approaches such as quantitative systems pharmacology (QSP), physiologically based pharmacokinetic (PBPK) analysis, and innovative population pharmacokinetic (PK) tools,” Zineh wrote. (RELATED: FDA’s OPQ, OCP tout 2019 highlights in new reports, Regulatory Focus 10 February 2020)
Eight workshops and webinars were hosted by OCP last year, with topics ranging from the risk of drugs with proarrhythmic effects, pediatric dose selection, topical drug development, and how hepatic impairment affects drug PK, and others. OCP also published 151 papers on topics related to clinical pharmacology and translational science, and contributed to 231 research projects during 2020. “Regulatory research is critical to advancing the science to facilitate both regulatory review and policy. OCP has also used research to address urgent public health needs this year including the COVID-19 outbreak and the opioid crisis,” the authors of the report noted.
OCP said that, for the future, “we will continue to move forward on mission-critical initiatives in OCP, including advancing MIDD, research and consults to address the ongoing opioid epidemic and sunscreen initiatives, pharmacogenomics to further personalized medicine, guidances and policies to articulate best practices in clinical pharmacology, and robust communication channels to ensure our partners can make informed decisions based on the latest scientific and regulatory information.”
Annual report: Office of Clinical Pharmacology


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