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The FDA Response To COVID-19 At Six Months: Regulatory Innovation In The Face Of A Pandemic

Anand Shah, M.D.

By Anand Shah & Stephen Hahn

The COVID-19 pandemic has significantly impacted American society, with more than 160,000 deaths and 5 million cases as of August 2020. A novel pathogen like SARS-CoV-2 is uniquely challenging because of the real-time learning curve imposed on the medical and scientific communities to understand how the virus works and how best to detect infections, treat their effects, and contain further spread. To meet these challenges, the all-hazards preparedness framework of the Food and Drug Administration (FDA) equips the agency with specific authorities for use during emergency situations. Actions to date range from efforts to expedite access to timely medical products to initiatives to protect consumers from health fraud.

Over the past six months, the agency’s multi-faced pandemic response has included both policy and programmatic actions. In terms of policy, FDA has sought to provide regulatory clarity on products (e.g., medical products, hand sanitizer, food) and processes (e.g., clinical trial operations, digital health use, supply chain oversight) affected by the pandemic, issuing more than fifty guidance documents and hosting dozens of webinars and virtual town halls for stakeholders. In terms of programs, FDA has worked to leverage its authorities for emergency use and focus its regulatory resources to support the development of innovations relevant to COVID-19. For example, FDA has issued emergency use authorizations to expand access to testing, and partnered with the National Cancer Institute to perform validation studies and the Reagan-Udall Foundation to collect real-world data on diagnostic performance. Likewise, FDA has developed the Coronavirus Treatment Acceleration Program to provide interactive regulatory support for therapeutic development, issued guidance for the development of safe and effective vaccines, and supported the National Institutes of Health’s public-private partnership for COVID-19 vaccines.

Responsive Regulation

Responsive regulation during a pandemic is a challenging endeavor. FDA decisions are always based on scientific evidence and rooted in a benefit-risk calculation that always puts the safety of patients first. Accordingly, as new evidence for COVID-19 emerges, FDA has worked to issue emergency use authorizations for regulated products that meet both the necessary scientific standard and the legal criteria for emergency use and to continually update its policies. For example, based on the results of validation studies for serology (antibody) tests, FDA revised its policies in May 2020 to include new recommendations for specificity and sensitivity. Likewise, based on null results from randomized controlled trials and reports of adverse events, FDA revoked an emergency use authorization for chloroquine and hydroxychloroquine in June 2020.

As physicians ourselves with roots in clinical practice, we recognize the challenges that the public may encounter when attempting to navigate the evolving regulatory landscape and overwhelming quantity of new COVID-19 data. For example, patients and providers may be unfamiliar with the distinction between an emergency use authorization and an approval or clearance. As leaders of the FDA, we recognize how agency actions and communications can provide clarity about product safety and insight into regulatory decision-making.

Consequently, to minimize misinformation and promote the transparency and rigor that is foundational in American medicine, FDA is publishing a multi-part series, here in the Health Affairs blog, outlining the regulatory landscape and key policy considerations for three key components of the COVID-19 response: teststherapeutics, and vaccines. With the rise of scientific misinformation, growing evidence of bad actors exploiting consumer anxieties by marketing fraudulent products, and public polls suggesting persistent COVID-19 vaccine hesitancy, FDA believes that communication such as this is imperative to provide clarity to consumers, providers, and policymakers.

Lessons Learned

We also hope that chronicling and communicating FDA’s actions to date will spur conversation from stakeholders about what lessons the agency can draw from the pandemic experience to support short- and long-term steps to modernize regulatory policies, processes, and programs. The agency recently launched the COVID-19 Pandemic Recovery and Preparedness Plan (PREPP), in which FDA will review all of the actions taken during the pandemic to both inform the next steps for COVID-19 recovery and also chart a course for strengthening the agency’s overall preparedness for future public health emergencies.

As part of this initiative, FDA will seek to identify which changes made during the pandemic should be considered for long-term implementation, which temporary policies should expire, and where additional resources and infrastructure investments can help ensure sufficient capacity to execute the agency’s mission. Continuous improvement is foundational in science and medicine, and FDA believes that the COVID-19 pandemic provides an important opportunity to identify forward-looking lessons to strengthen the agency’s ability to protect and promote the public health.

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