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Life sciences companies may see temporary pandemic policies become permanent

Erin McCallister Senior Manager, Health Research Institute, PwC US June 04, 2020

FDA Commissioner Stephen Hahn said the agency could make some temporary policies permanent after the COVID-19 pandemic ebbs. The FDA has issued a flurry of new guidance documents and Emergency Use Authorizations, and has opened up new pathways since the crisis began to unfold in the US. “As this pandemic evolved, it was clear that some FDA processes needed to be adjusted to accommodate the urgency of the pandemic,” Hahn said in a video posted to YouTube on June 1.

“I think the entire FDA team has now seen firsthand that we need to look at some of our processes and policies,” Hahn said. “I have instructed my staff to identify the lessons learned from this pandemic and what adjustments may be needed, not just to manage this or future emergencies, but to make FDA itself more efficient in carrying out our regulatory responsibilities. … Many of the permanent changes that we will implement really represent an acceleration of where we were headed before [COVID-19].”

While he did not mention which specific guidance documents, new pathways or policies would eventually become permanent, Hahn did offer examples of new tools that have been used to expedite or modify clinical trials in response to the outbreak and types of data the FDA has used and could use in the future to inform its regulatory decisions.

He discussed the FDA’s collaboration with the National Institutes of Health on a master protocol for therapeutic candidates to treat individuals infected with SARS-CoV-2, the virus that causes COVID-19. Master protocols allow multiple agents to be tested in a single trial with just one control arm and permit new agents to be added to the study without having to design a new one. These protocols have been employed by the FDA and the World Health Organization during the pandemic.

Hahn followed that with an example of decentralized trials where the studies are conducted more locally with the patient’s provider and through the use of electronic health records.

During the pandemic, the FDA has released guidance related to the use of remote monitoring technologies to evaluate patients who have tested positive for COVID-19 as well as to help healthcare providers and clinical trial investigators keep track of important health metrics as hospitals and physicians offices were closed.

Greater use of real-world evidence could be another avenue that the FDA expands based on its experience with COVID-19. “Evaluation of real-world data has the potential to provide a wealth of rapid, actionable information to better understand disease symptoms, describe and measure immunity, and use available medical product supplies to help mitigate potential shortages,” Hahn said. “The more experience we have with real-world evidence, the more confidence we will have in using it for product decisions.”

HRI impact analysis

The programs highlighted by Hahn provide new opportunities to build on recent changes at CMS. Some of them are already permanent, while others were implemented as a result of the pandemic but could also stick around.

For example, as the outbreak unfolded, some pharmaceutical and life sciences companies began to shift to virtual trials or to plan for remote patient monitoring as an element in the study design. Additionally, physicians groups such as the American Society of Clinical Oncology (ASCO) are providing a road map to restarting clinical trials and patient visits that center on greater use of remote monitoring and decentralized clinical studies.

If the FDA opens the door to greater reliance on real-world data to support new drug or device approvals, the implementation of CMS’ interoperability rule could mean that these data are easier to obtain in a standardized and interpretable format. Because of the pandemic, CMS-regulated programs have until July 1, 2021, to make patient claims and encounter, cost and some clinical information available through a patient access application programming interface.

CMS has also unleashed a dizzying number of new protocols and rule modifications in response to the pandemic, including loosening rules around telehealth. Like the FDA, CMS Administrator Seema Verma has recently suggested that the changes surrounding telehealth could become permanent.

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Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Crystal Yednak

Senior Manager, Health Research Institute, PwC US

Erin McCallister

Senior Manager, Health Research Institute, PwC US

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