09.30.21

Burr Releases New Report with Recommendations to Strengthen FDA’s Regulatory Readiness

Today, Senator Richard Burr (R-NC), Ranking Member of the Senate Health, Education, Labor and Pensions (HELP) Committee, released a new report with recommendations for strengthening the U.S. Food and Drug Administration’s (FDA) regulatory readiness, building on lessons learned from the pandemic to better prepare for the future.

“As we take stock of lessons learned from the COVID-19 pandemic, we should build on FDA’s leadership and experience to improve our readiness for future public health emergencies and to enable private sector partners to innovate quickly,” the report states.

The report continues, “Accelerating the development and review of countermeasures for future threats, improving the resilience of medical product supply chains, and strengthening FDA’s regulatory readiness and operations will help ensure our nation is more resilient against future threats. Congress must leverage lessons learned to ensure FDA has the tools, and innovators have the regulatory certainty, necessary to develop the next wave of medical countermeasures and cutting-edge treatments for patients.” 

The policy brief, titled “Strengthening FDA’s Regulatory Readiness: Implementing Lessons Learned from the COVID-19 Pandemic,” is the fourth in a series released by the Ranking Member on the federal government’s continued pandemic response. The first installment, titled “Modernizing CDC: Ensuring a Strategic Approach and Improving Accountability,” was released in May 2021. The second paper, titled “Reforming and Strengthening ASPR: Ensuring Specialized Capabilities, Sufficient Capacity, and Specific Authorities to Meet 21st Century Public Health Security Threats,” was released in June 2021, and the third paper, titled “Preparing for Future Health Threats: Improving and Sustaining Foundational Public Health Capabilities in Response to COVID-19,” was released in July 2021.

Key recommendations:

The policy brief, “Strengthening FDA’s Regulatory Readiness: Implementing Lessons Learned from the COVID-19 Pandemic,” examines FDA’s critical role throughout the COVID-19 pandemic. This includes addressing the challenges that arose during the pandemic response and building on these lessons to apply them to future response efforts and across the agency. 

Specifically, the report includes the following recommendations.

·         Accelerating the Development and Review of Medical Countermeasures: FDA should build on the unprecedented steps it took to expedite the development and review of life-saving tests, therapeutics, and vaccines by encouraging the use of platform technologies, leveraging cross-agency scientific resources, and providing a clear and predictable pathway for test developers.

·         Improving Medical Product Supply Chain Resilience: The COVID-19 pandemic demonstrated the importance of a resilient medical product supply chain. The FDA should prioritize the sustainability of our medical product supply chains to prevent future disruptions by simplifying regulatory processes, incentivizing new ways to manufacture medical products, and modernizing FDA’s use of remote tools to conduct inspections.

·         Applying Lessons Learned to Strengthen FDA’s Regulatory Readiness: FDA should leverage the regulatory authorities and flexibilities that were used throughout the pandemic to inform long-term improvements at the agency, strengthening overall FDA readiness and operations and enhancing real-time communication with American innovators. 

To read the full policy brief, click here.