By: Robert M. Califf, M.D., Commissioner of Food and Drugs and Hilary Marston, M.D., M.P.H., Chief Medical Officer
The U.S. Department of Health and Human Services is planning for the federal Public Health Emergency for COVID-19 declared under the Public Health Service Act to expire on May 11, 2023. We’ve arrived at this point because of the U.S. government’s historic investments and our collective efforts to mitigate COVID-19’s worst impacts. While the HHS public health emergency is ending, COVID-19 remains a high priority and the U.S. Food and Drug Administration will remain engaged with numerous activities to protect and promote public health.
And while the virus is still with us, causing illness and death in some cases, the good news is we now have more tools to help protect many in our families and communities from the most harmful impacts of COVID-19.
COVID-19 vaccines are one of the most significant and important public health interventions we have access to, and the available data continue to demonstrate that vaccines prevent the most serious outcomes of COVID-19, including severe illness, hospitalization, and death. We also have hundreds of tests and several authorized and approved treatment options for COVID-19. The FDA remains committed to continuing to use every tool in our toolbox to fight COVID-19, including pivoting as the virus adapts and continuing to help advance medical products to protect the most vulnerable populations. The agency will continue to support efforts on future COVID-19 vaccine and treatment needs.
Staying up to date on COVID-19 vaccination is the best thing Americans can do to help protect themselves and their families.
The COVID-19 vaccines, therapeutics and medical devices that are authorized will not change as a result of the public health emergency ending in May. The agency may continue to issue new Emergency Use Authorizations (EUAs) if the criteria for issuance are met and if the situation warrants it. Moreover, existing EUAs will remain in place as appropriate and the agency will review marketing submissions for approval, licensure, de novo classification, or clearance.
Importantly, we are continuing efforts to understand and support treatments for Long COVID. The agency recently hosted a virtual public meeting on Patient-Focused Drug Development for Long COVID. This meeting provided us the opportunity to obtain initial input from patients about their experiences with Long COVID, including how Long COVID affects daily life, symptoms that matter most to patients, and current approaches to treating Long COVID. We are also funding research in this area.
As we reflect on the devastating losses and lasting impacts the COVID-19 pandemic has had worldwide, we will use the lessons we’ve learned to be thoughtful about preparing for future public health emergencies and use the knowledge gained from our experience with COVID-19 to inform our future response efforts.
Anticipating Misinformation and Disinformation
One area we at the FDA feel passionately about is the need to do more to address the misinformation and disinformation that has become more prevalent and is undermining confidence in science and public health and weakening trust in governmental and other institutions, including the FDA. As we think about emergency preparedness, we’d be remiss not to mention the need to get in front of what we know can happen when tackling a public health crisis.
Misinformation, spreading largely through social media, is leading people to make adverse choices regarding their health, from continuing to use tobacco products or vape, turning to unproven products, or failing to use medicines and vaccines that have substantial data showing benefit, such as FDA-approved and authorized vaccines and antivirals that are available for COVID-19. Addressing misinformation will require a true collaborative effort to build trust in science that goes well beyond the FDA – involving the development of a proactive network that includes not just our federal partners, but regulated industry, health systems and clinicians and universities, along with public health and advocacy groups.
FDA’s Public Health Emergency Preparedness and Response Mission
The Administration’s National Biodefense Strategy and Implementation Plan on Countering Biological Threats, Enhancing Pandemic Preparedness, and Achieving Global Health Security describes in detail a set of transformative capabilities the U.S. government aims to build to defend against future pandemics and biological threats. These include the capability to develop and safely deploy medical countermeasures against novel pathogens much more rapidly than is possible today. These capabilities will require additional resources and scientific breakthroughs.
The FDA has long played a key role in this effort, to make sure that medical countermeasures can be rapidly and rigorously validated for pandemic response. Preparation for future public health emergencies depends on utilizing the many strategies—often decades in the making—that led to a successful COVID-19 response as well as the establishment and refinement of authorities and flexibilities that allow the agency to identify and mitigate risks while promoting innovation. This includes continuing to leverage existing relationships with entities outside of the FDA in emergency response situations. The agency’s capacity to drive future emergency responses depends on continued collaborations with regulatory, academic, state, tribal, local, territorial, and industry partners even in the absence of a crisis.
Next Steps and Planning for the Future
The FDA will continue to improve the capabilities of the agency and prepare to effectively address future crises such as public health emergencies, supply chain disruptions, geopolitical changes, and natural disasters.
For example, the COVID-19 pandemic highlighted vulnerabilities in medical product supply chains, in part due to unprecedented global demand for products and their raw materials. The agency has intervened and established new or more comprehensive programs to help address this. These efforts will continue as we position the agency to tackle future public health emergencies by:
- Monitoring the availability of medical products by integrating data from a wide variety of mandatory and voluntary reporting sources such as commercially available data sets, product manufacturers, raw material and component suppliers, active ingredient manufacturers, group purchasing organizations, distributors, suppliers and end-users, like hospitals, providers, and pharmacies.
- Predicting supply chain vulnerabilities and risks by integrating internal and external data sets for analysis using artificial intelligence, including natural language processing and machine learning.
- Preventing or mitigating shortages with strategies such as shelf-life extensions, expedited review of manufacturing supplements and generic drug applications, exercising temporary enforcement discretion for new sources of medically necessary drugs, and requesting that manufacturers establish risk management plans to mitigate the potential for shortages, as appropriate.
The FDA is also initiating a new inspection planning system that will be more efficient, transparent and adaptable to changing needs. This will help prioritize high-impact inspections such as those for facilities manufacturing critical products. The FDA has returned to its pre-pandemic inspection procedures and as a result the majority of the domestic inspections are unannounced. Building a workflow management system will provide a single source of data and real-time access to information to support the best regulatory decisions. The FDA also is developing new approaches to inspect facilities utilizing novel advanced manufacturing techniques.
There have been lessons learned about how the FDA’s authorities could be modernized in the reauthorization of the Pandemic and All-Hazards Preparedness Act to ensure our actions could be even more effective. Providing greater transparency into supply chains to improve resiliency and prevent and mitigate shortages of medical products and the food supply, ensuring operational readiness and surge capacity within the FDA inspectorate and review staff, and improving laboratory testing regulation are priorities that will enhance national security and improve public health preparedness.
As an agency, we remain committed to planning for the future, taking into account the many important lessons learned from the COVID-19 public health emergency.