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Critical Role of Office of New Drugs in FDA’s Pandemic Response

The office’s director explains how it has leveraged new practices to quickly review and approve treatments amid the COVID-19 pandemic.

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It’s been a whirlwind of a year-plus as a result of the COVID-19 pandemic, and the agency behind a large part of the work behind testing and treating the disease is the Food and Drug Administration’s Office of New Drugs, part of the agency’s Center for Drug Evaluation and Research. The agency recently discussed how it has quickly met unprecedented challenges in drug evaluations and how it will glean lessons learned for the future of new drugs.

“We have already launched working groups to look carefully at the experiences we’ve had in the past year, consider the lessons, and whether there are changes we can consider that will make us more efficient as an organization — both if there is a future pandemic, but also in our day-to-day work after the pandemic resolves,” the office’s director, Dr. Peter Stein, told GovernmentCIO Media & Research.

OND provides regulatory oversight of investigational studies during drug development, as well as decisions regarding marketing approval for new drugs. The office also delivers guidance on clinical, scientific and regulatory matters.

Throughout the pandemic, OND reviewed submissions for potential COVID-19-related therapies regulated by CDER, answered inquiries from external stakeholders and addressed various policy issues.

The office also collaborated with the National Institutes of Health, industry and academic partners on the Accelerating COVID-19 Therapeutic Interventions and Vaccines consortium to assist in clinical trials that investigated potential therapies for the coronavirus.

OND’s pandemic response included assessing new and existing therapeutics that showed promising results in COVID-19 patients, Stein said. Over the course of March to December 2020, OND authorized seven emergency use authorizations for COVID-19 and contributed to 10 COVID-19-related guidances.

“These included guidance on the pre-[investigational new drug] meeting request content for COVID-19 drugs or biological products, as well as guidance on the development of drugs and biological products to treat and prevent COVID-19, including population, trial design, efficacy endpoints, safety considerations and statistical considerations,” Stein said.

Like the rest of government, CDER and OND had to quickly pivot its priorities to be successful in a virtual environment. FDA worked quickly to ensure its workforce had access to highly secure, virtual platforms to successfully meet its mission remotely.

“We depend on the technology that provides us access, connections and platforms to work and collaborate,” Stein said.

OND’s policy team also led development of the FDA’s special emergency program called the Coronavirus Treatment Acceleration Program (CTAP) to explore and determine possible COVID-19 therapies via a dashboard.

The program expedited the development of potential COVID-19 therapeutics and quickly moved new therapies to patients. A “triage team” helped OND review over 320 trials and over 570 drug development programs in the planning stages as of Dec. 31, 2020.

“There was an ‘all-hands-on-deck’ approach,” Stein said.

Of course, the work is not over. The office is working on evaluating incoming new drugs like small interfering RNA (siRNA), dual-targeted antibodies and other innovative treatments.

Moving forward, Stein said that one of the efforts in the new drug regulatory modernization program will improve knowledge-management abilities. This initiative will help rapidly identify and use prior experience to inform future decisions.

“It’s essential that as an organization, OND gains experience with such technologies and develops the expertise to be able to provide the best regulatory guidance,” Stein said.

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