CDER regulatory science division touts 2020 accomplishments

In its 2020 annual report, the division of the US Food and Drug Administration (FDA) tasked with addressing emerging regulatory issues and developing new tools and approaches for regulatory reviews said it was able to expand its efforts despite the COVID-19 pandemic impacting most of the year.
 
“2020 was a challenging year. In addition to adjusting to new work environments related to the COVID-19 pandemic that involved 100% teleworking for some staff and laboratory work with new restrictions, DARS experienced the sudden loss of two highly valued team members. And yet, our multi-disciplinary team continued to come together and ‘step up to the plate’ to advance high-priority mission-critical projects and take on new responsibilities throughout the year,” wrote DARS Director David Strauss.
 
Strauss added that the division contributed to the agency’s COVID-19 response by providing regulatory consults and reviews for investigational drugs for COVID-19 in addition to its broader focus of advancing translational models and tools used in the drug review process.
 
“DARS also greatly expanded its clinical trials operations, running three clinical trials related to streamlining biosimilars development and studying safety questions related to opioids and over-the-counter drugs,” Strauss wrote. In 2019, the division conducted a clinical trial to quantify the systemic absorption of sunscreen ingredients and has since published additional research on the topic.
 
The division served as the rapporteur in the effort to update the International Council for Harmonisation (ICH) E14 and S7B guidelines on the clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential and leads research for the Comprehensive in vitro Proarrhythmia Assay initiative. Overall, the division’s cardiac safety research program yielded 25 publications and three FDA-sponsored clinical trials to assess cardiac safety biomarkers. (RELATED: ICH updates: E14 consultation, Health Canada implements M9 guideline, Regulatory Focus 28 August 2020).
 
In the wake of concerns over NDMA impurities in ranitidine, DARS also conducted a clinical trial evaluating urinary excretion of NDMA after ranitidine administration. (RELATED: FDA seeks withdrawal of heartburn drugs due to new carcinogen concerns, Regulatory Focus 1 April 2020; Analysis: Potentially high NDMA levels after ranitidine ingestion, Regulatory Focus 2 February 2021).
 
In 2020, DARS said it saw steady demand for (Quantitative) Structure-Activity Relationship [(Q)SAR] consults under its Computational Toxicology Consultation Service, averaging consultations for 11 chemical structures per week. DARS also performed 31 divisional consults and five review team contributions in 2020, up from 21 consults during the previous year. Among the consults the division conducted were reviews of renal and hepatic toxicity associated with Gilead Sciences’ COVID-19 drug Veklury (remdesivir) and a review of in vitro data used to expand the approval of three cystic fibrosis drugs to cover hundreds of rare genetic variants that were not studied in clinical trials.
 
The report also details other in vitro, in vivo and in silico models research conducted by the division that resulted in 16 publications.
 
Report