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FDA Reshuffles Priorities to Meet COVID-19 Trial Demand


The FDA has had to rely on triaging to address its most critical priorities during the unfolding coronavirus disease 2019 (COVID-19) pandemic, according to Peter P. Stein, MD.

The sudden influx of coronavirus disease 2019 (COVID-19)–related trials work at the FDA has required judiciously pulling resources from various departments at the agency to support those efforts, according to Peter P. Stein, MD, director of the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research (CDER).

“We certainly had to prioritize, and we did provide very early internal guidelines on how to most appropriately prioritize what work had to be considered key, and most importantly, what work might be delayed if it had to be,” Stein said in a discussion on COVID-19 at the DIA 2020 Biosimilars Conference. CDER is charged with regulation of OTC and prescription drugs, including biologics and generics.

In late August, the FDA reported it had 270 clinical trials underway specifically related to potential COVID-19 treatments, and it said more than twice that number were in the planning stages. Concurrent with those concerns, the FDA’s Office of Therapeutic Biologics and Biosimilars reported that it is tracking 90 biosimilar development projects. The pace of biosimilar approvals is off sharply from last year, currently standing at 2 for 2020 vs 10 for 2019.

Working Across Silos

“We have had to make sure that we were able to work across silos to move staff across divisions,” Stein said. “We have lots of folks in divisions that weren’t directly affected by COVID-19 therapeutic work moving to divisions to support the…regulatory review work.”

The FDA has established interdisciplinary groups to work across departmental lines to address critical needs and track the effects of COVID-19 on clinical trials, and during the pandemic, the agency has “been working virtually, and we’re getting used to it, and we’re pretty productive,” Stein said. “I think we’ve learned how to work in this environment.” Improvisations to keep the FDA well integrated and effective have included “town hall” meetings, staff meetings, and similar virtual interactions.

Progress with all non–COVID-19 trials has been "hugely" affected by the pandemic, he said. In guidance, the FDA has allowed that modifications to trials necessitated by COVID-19 would be acceptable, but convincing evidence will be required for the FDA to reach drug approval decisions. Challenges imposed by COVID-19 have included patient inability to participate in trials and the potential for COVID-19 infections to compromise trial results.

Stein said the FDA has seen fruit from its recent emphasis on “master protocols,” which are trials that evaluate multiple investigational drugs simultaneously. “I think we’ve learned that master protocols are an incredibly important way that we can be able to evaluate therapies more efficiently and effectively.”

“We’ve also had to think about how to evaluate a pack of trials where there is more missing data that we’d like to have—how do we evaluate those to make sure we get as much information from them as we possibly can. I think we’ve also learned more about how real-world evidence can be used particularly as it relates to practice patterns, disease characteristics and drug utilization. I think we’ve learned a tremendous amount.”

Dip in Biosimilar Utilization

From the private sector standpoint, utilization of biosimilars and other specialty products dipped between 10% and 30% as the pandemic unfolded owing to factors such as patients delaying care and temporary clinic shutdowns, according to Sean McGowan, senior director of Biosimilars at AmerisourceBergen, a drug wholesaler. “There was absolutely an impact on utilization, and especially in the biosimilar space,” he said.

“But we have seen a very good and solid recovery in these clinic and health system spaces, and utilization picking back up, not only for the biosimilar products but also for the specialty product market,” he said.

Whereas the approvals process was challenged at the FDA and the wholesale trade saw dips in utilization of specialty drugs, provider-based administration of these agents, including biosimilars, has fallen markedly during the pandemic, according to Juliana M. Reed, MS, vice president of Corporate Affairs, Global Immunology and Inflammation, and Biosimilars for Pfizer.

In the categories of Crohn disease, multiple sclerosis, rheumatoid arthritis, and retinopathy, drug administrations dropped 17%, 30%, 34%, and 45%, respectively, she said, citing IQVIA data.

COVID-19 has made it clear that biosimilars can play an important role in saving money on health care, Reed said. “COVID-19 is opening everybody’s eyes to that. As stakeholders, we are leaving money on the table, and that is something that we need now, especially as we’re seeing how COVID-19 has affected the economy.” She said office-based practices had patient visit reductions of 60% in the first months of the COVID-19 outbreak and said an early projection suggested hospitals stand to lose $323.1 billion in 2020.

On the plus side, the pandemic has changed how health care is administered in such a way that improves access for patients, Reed said. Patients can be classified as homebound and receive infusions at home, and physicians are able to direct infusions via digital links as they are performed by clinic or hospital staff or contracted health workers.

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