OND Managed a Slew of EUAs, a Reorg, PDUFA Goals and Regular Business During Pandemic, Says Annual Report

Despite the unprecedented disruption and shift in priorities that COVID-19 brought to FDA’s Office of New Drugs (OND) in 2020, the office approved 53 novel drugs, published 31 new guidances and wrapped up the reorganization it had been working on since 2019, said Peter Stein, OND’s director, in the office’s annual report.

“The outbreak of COVID-19 presented an unprecedented challenge to OND in 2020,” said Stein. “The extensive efforts by the pharmaceutical industry, academic investigators and the National Institutes of Health (NIH) to find therapeutics for COVID-19 led to a sudden increase in workload for staff across OND.”

During 2020, the OND, part of the agency’s Center for Drug Evaluation and Research (CDER), reviewed more than 320 trials for potential COVID-19 therapeutics and more than 570 drug development programs in the planning stages. Ultimately, according to the report, OND contributed to the authorization of seven emergency use authorizations (EUAs) for COVID-19 vaccines and treatments between March and December 2020.

Those included chloroquine phosphate and hydroxychloroquine sulfate (subsequently revoked on June 15); Veklury (remdesivir); MultiBic; Propoven 2 percent; Regiocit; Bamlanivimab; baricitinib (Olumiant); casirivimab and imdevimab. The EUA for remdesivir paved the way for its subsequent approval in October 2020 as the first FDA-approved treatment for COVID-19.

OND contributed to 10 COVID-19-related guidances from March through December 2020, including three COVID-19 guidances authored by OND.

All the while, COVID-19 threatened to disrupt numerous ongoing clinical trials for other indications, so OND divisions worked quickly with sponsors to manage and modify those trials to ensure they could continue in a new, largely virtual environment, Stein added.

At the same time, said Stein, the office met or exceeded many of the Prescription Drug User Fee Act (PDUFA) review goals.

OND’s restructuring involved creating offices focused on broad therapeutic areas, such as neuroscience or inflammation/immunology. This result was eight new clinical offices that oversee 27 review divisions, plus six nonclinical review divisions. In addition, the reorganization created a series of six “infrastructure” offices, providing support across all the clinical offices and divisions, according to the report.

The reorganization also created new a division of Pharmacology/Toxicology (Pharm/Tox) in the clinical offices. Pharm/Tox reviewers evaluate nonclinical data for new drugs to aid in the selection of safe starting and maximum doses for first-in-human clinical trials, said OND in its report, adding that reviewers also look for potential toxicities to monitor in clinical trials and assess toxicities not addressed in trials.

Stein said he’s bullish on what OND can accomplish in 2021. “2020 has shown the resilience and the broad and deep capabilities of OND as an organization,” said Stein. “As we face the ongoing demands of COVID-19 and the new demands of the changing drug development landscape, our organization is well-poised to meet these and other new challenges.” — Suz Redfearn