Actions Required Now for EUAs as the U.S. Public Health Emergency Ends in May

Lynne Ensor, Ph.D., is Senior Vice President & Head of Strategic Compliance Consulting at Parexel, and has been a consultant for the biopharmaceutical industry since 2019. Her expertise includes sterile product manufacturing and testing, pharmaceutical microbiology, facility compliance, and regulatory strategy. She was previously employed by the U.S. Food and Drug Administration (FDA) for 21 years, most recently as the Deputy Director (Acting) in the Office of Process and Facilities (OPF)/Office of Pharmaceutical Quality/CDER.

The public health emergency declared in the U.S. nearly three years ago in response to the COVID-19 pandemic allowed for the trigger of the FDA emergency use authorization (EUA) process to accelerate development and availability of vaccines and treatments to help allay the crisis. The industry rose to the challenge, even while making radical, comprehensive changes in normal procedures. Regulators, too, had to adapt quickly to different structures and expectations while managing their workloads under great strain, with safety and quality as a high priority. To date, the EUA process has been used for more than 750 products, covering COVID vaccines, drugs, biological therapeutic products, devices, and more – compared to less than 40 in the previous 16 years.

Thanks in large part to these efforts, we are emerging from the COVID-19 crisis, and our industry has long expected the return to “normal” in the U.S regulatory environment. That day is drawing near: On May 11, 2023, the public health emergency (PHE) is anticipated to officially end, and with it, this extraordinary use of EUA. The Biden administration and the FDA made this announcement January 30, intending to allow adequate time for companies to make the transition and to ensure uninterrupted availability of supplies.

This will have significant implications for companies granted EUA status. These are the primary considerations and actions required.

1.      Maintaining U.S. product distribution through FDA communication: The FDA requires communication of a plan for COVID-related products currently granted EUA by the PHE termination date. The plan must specify whether a company will withdraw the EUA or submit a marketing application. Every product granted EUA will need to undergo the typical FDA approval process before the products can be distributed in the U.S.

Submitting this plan by May 11, 2023 is essential for the continued distribution of products in the U.S.

2.      Preparing for on-site inspections: As part of the approval process, the FDA is pivoting to increased on-site inspections. With quality assurance a long-term priority of the U.S. regulatory authorities, there is renewed focus, post-COVID, on enhancing supply chain safety and integrity by assuming more control.

Consequently, a number of parallel legislative initiatives are underway in Congress, one of which aims to strengthen the risk-based frequency and diligence of inspections, including increasing unannounced foreign inspections. These regulatory inspections encompass manufacturing, shipment, handling, and data quality management systems, as well as clinical trial setup, safety, monitoring, and data management.

Maintaining inspection readiness is a paramount requirement for every drug company, especially for those without a history of compliance, or those that have experienced challenges in the past. Failure will result in removal of the product from the market.

The best practice is to establish a continuous, ongoing program that requires a commitment to maintaining high-quality processes and deliverables. Building a quality culture is fundamental to efficient processes to help expedite approval, to reducing the burden and costs of inspection readiness, and to fostering a trusting relationship with regulators.

Is your organization prepared?

Organizations impacted by the termination of the public health emergency are subject to regulatory requirements that are likely to tax current resources.

Partner with Parexel’s Strategic Compliance Consulting team for:

• Review of clinical data for completeness and quality
• Strategic regulatory advice on how to engage with the FDA regarding next steps for preparation/submission of the marketing application
• Direct support to draft and submit the marketing applications globally
• Inspection readiness support at manufacturing sites, including performing audits of any vendors to ensure regulatory compliance and that appropriate quality agreements are in place

​​​​Specific to supporting the fight against the COVID-19 pandemic, Parexel has been working with customers on successfully developing treatments and supporting their manufacturing compliance since January 2020. That’s why we’re able to thoughtfully guide organizations through regulatory strategy, compliance, and partnerships. Together, we identify ways you can improve, then equip you with the tools to get there.