COVID-19, reorg dominated 2020 for FDA Office of New Drugs

Regulatory NewsRegulatory News | 19 March 2021 |  By 

Staff in the U.S. Food and Drug Administration’s Office of New Drugs (OND) began 2020 with a focus on completing the office’s reorganization, but they quickly shifted focus to the global pandemic and supporting accelerated development of new therapeutics to prevent or treat COVID-19, according to the OND’s inaugural annual report.
“Despite the added workload, there were no significant disruptions to OND’s work as staff managed to meet and/or exceed many of the Prescription Drug User Fee Act (PDUFA) review goals, approve 53 novel drugs, publish 31 new guidances, and maintain regulatory and programmatic operational responsibilities under tight deadlines and difficult circumstances,” OND Director Peter Stein, MD, wrote in the 2020 annual report.
COVID-19 pivot
OND was involved in seven Emergency Use Authorizations (EUAs) related to COVID-19 therapeutics in 2020. The office also led the development of the Coronavirus Treatment Acceleration Program (CTAP), a special emergency program to explore potential coronavirus therapies. As part of this process, OND reviewed more than 320 trials and more than 570 drug development programs in the planning stages in 2020.
OND also contributed to 10 guidance documents on COVID-19, including guidance on the development of drugs and biologics to treat and prevent COVID-19, guidance on conducting clinical trials during the pandemic, and several guidance documents on hand sanitizer safety.
“Early in the pandemic, the Office of Nonprescription Drugs (ONPD) led extensive efforts to ensure the availability of safe alcohol-based hand sanitizers, working with other offices across [the Center for Drug Evaluation and Research] in this huge effort,” the FDA wrote. “These guidances were focused on informing industry and the public of safety measures regarding the manufacturing and use of hand sanitizer products.”
OND staff also worked to keep clinical trials for other indications on track, despite disruptions from COVID-19. “[D]ivisions worked quickly with sponsors to manage and modify those trials to ensure they could continue in a new, largely virtual environment,” the FDA wrote.
Office reorganization
OND, which has more than 1,300 employees, also completed a planned reorganization that began in October 2019. One element of the plan was a realignment of offices and divisions based on inter-related disease and therapeutic areas. The aim was to create offices that focused on broad therapeutic areas, such as neuroscience, and to create divisions that are focused on disease areas.
The result was eight clinical offices overseeing 27 review divisions, along with six non-clinical review divisions. The reorganization also created six infrastructure offices that provide support across all clinical offices and divisions, including providing advice on policy issues or support for regulatory operations.
The reorganization also created new divisions of Pharmacology/Toxicology in the clinical offices, with the goal of spurring increased cross-divisional collaboration.
“The OND reorganization was a major undertaking as it restructured many of the clinical offices and divisions, in addition to creating new cross-functional nonclinical offices,” Stein wrote.
2021 challenges
The report also provides a forecast for challenges that OND expects to face in 2021. Along with the continuation of the pandemic, the report highlights an anticipated greater focus on drug development in rare diseases and subtypes; new platforms for drug development, such as siRNA; an increase in the use of real-world data; and a greater need to engage with patients.
“The role of patients in drug development is also, appropriately, increasing. OND has always looked to patient input to inform regulatory decision-making; after all, our work is focused on making patient’s lives better. So, understanding their perspectives and the ways in which their disease impacts their lives, is essential to our work and decisions,” FDA wrote. “Over time, we must, therefore, continue to increase our efforts to engage with patients, learn from them, and utilize their input in our work.”
OND report


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