The COVID-19 pandemic has disrupted the world in countless ways, including the pharmaceutical industry's regulatory environment. In response to the public health emergency declared in the U.S. nearly three years ago, the FDA emergency use authorization (EUA) process was triggered to accelerate the development and availability of vaccines and treatments to help combat the crisis.
The industry responded to the challenge by making radical, comprehensive changes in normal procedures, while regulators adapted quickly to different structures and expectations under great strain, prioritizing safety and quality.
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. This extraordinary use of EUA has allowed the pharmaceutical industry to provide necessary products to help allay the COVID-19 crisis.
However, as we emerge from the COVID-19 crisis, the Biden administration and the FDA announced on January 30 that the public health emergency (PHE) is anticipated to officially end on May 11, 2023. This announcement intends to allow adequate time for companies to make the transition and ensure uninterrupted availability of supplies. This will have significant implications for companies granted EUA status, and they must take necessary actions to prepare for the end of the EUA process.
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. Companies must prepare to submit comprehensive applications for the FDA's review, which includes clinical trial data, manufacturing processes, and quality control data. The approval process may be lengthy, and companies must ensure that they have adequate resources to support the application process.
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 the removal of the product from the market.
Companies must prioritize inspection readiness and 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.
Regulatory Compliance Support for Pharmaceutical Companies
The end of the EUA process will require pharmaceutical companies to prioritize regulatory compliance and be prepared for the increased scrutiny that comes with the typical FDA approval process. Companies must consider partnering with regulatory compliance experts to navigate this transition successfully.
BioBoston Consulting's Strategic Compliance Consulting team can provide comprehensive support to pharmaceutical companies impacted by the termination of the public health emergency.
Another important consideration for companies granted EUA status is the need to gather and analyze additional data to support the approval process. While the EUA process allowed for expedited approval based on limited data, the standard FDA approval process requires more robust data to support safety and efficacy claims. Therefore, companies will need to continue to collect and analyze data to support their products' safety and effectiveness.
It's also important to note that the end of the public health emergency and the termination of EUA status for COVID-related products does not mean the end of the pandemic. The COVID-19 virus is still a threat, and there may be a need for continued development of treatments and vaccines to address new variants or potential future pandemics.
In addition to the impact on companies with EUA status, the end of the public health emergency will also have broader implications for the regulatory environment in the United States. As mentioned earlier, there will be a renewed focus on supply chain safety and integrity, which will likely lead to more rigorous inspections and increased enforcement of regulatory compliance.
Furthermore, the FDA is expected to resume its regular pre-approval inspection program, which was suspended during the pandemic. These inspections are conducted to assess a drug or biologic's manufacturing and control processes, and they are critical for ensuring the safety and efficacy of pharmaceutical products.
As a result, it's crucial for companies to prepare for these inspections and ensure that they are in compliance with all regulatory requirements. This includes maintaining accurate records, implementing effective quality control measures, and developing robust supply chain management practices.
The end of the public health emergency also presents an opportunity for companies to evaluate their regulatory compliance programs and identify areas for improvement. This could include enhancing training programs, implementing new technologies to improve quality control and supply chain management, and developing more effective communication strategies with regulatory authorities.
Partnering with a regulatory compliance expert like Bioboston Consulting can be an invaluable resource for companies navigating the post-pandemic regulatory environment. Bioboston Consulting's Strategic Compliance Consulting team can provide guidance and support for a wide range of regulatory compliance issues, including clinical data review, regulatory strategy, and inspection readiness.
Additionally, Bioboston Consulting can help companies develop and implement effective quality management systems to ensure compliance with all regulatory requirements. This includes developing robust supply chain management practices, implementing effective quality control measures, and maintaining accurate records to support regulatory compliance.
In conclusion, the end of the public health emergency and the termination of EUA status for COVID-related products will have significant implications for the regulatory environment in the United States. Companies will need to prepare for increased regulatory scrutiny and ensure that they are in compliance with all regulatory requirements.
Partnering with a regulatory compliance expert like Bioboston Consulting can be an effective way for companies to navigate the post-pandemic regulatory environment successfully. By taking proactive steps to prepare for the end of the public health emergency, companies can ensure the continued availability of their products in the U.S. market and position themselves for long-term success in the pharmaceutical industry.