Within Johnson & Johnson’s Office of the Chief Medical Officer, safety assessment that is objective and science- and evidence-based is at the core of what we do and is built into every stage of our products’ life cycles—from development to post-launch. But just how do we do it?
Preclinical testing, clinical studies and observational data play an important role in the research and development (R&D) of our medicines, vaccines and medical devices. The data from these sources provide important insights and information that helps us understand the potential risks and benefits of any investigational product. These studies also provide the critical information needed to seek and obtain approval from government health authorities to bring new medicines and products to the people who need them. In addition to having an ethical code that guides our research and development activities, our processes follow strict guidelines on the ethical treatment of trial participants and on how to protect their health and safety.
Read a Q&A with Johnson & Johnson’s Gary Eichenbaum, Ph.D., Vice President, Translational Science and Safety, Office of the Chief Medical Officer, on the role of translational science in product development safety.
We also have formal processes involving committees of experts who perform governance reviews and provide input on how R&D teams should evaluate and enhance the safety profile at the product development stage. This includes our First-in-Human Committees, which carefully review safety data, study designs and/or launch plans before our products are used in people; and our Development Committees, which review product development plans to ensure that our products address unmet needs and benefit the people who will ultimately use them.
Day-to-day safety reviews and decisions related to product safety are made by multidisciplinary safety management teams. Our sector Medical Safety Councils, which are chaired by the sector Chief Medical Officers, manage more complex safety assessments and decisions. The Johnson & Johnson Medical Safety Council, chaired by the Johnson & Johnson Chief Medical Officer, advises as needed and sets standards and policies related to medical safety.
Our R&D groups submit all required information to regulatory health authorities across the globe for products that require regulatory review, including results of clinical trials and other documentation describing the safety and efficacy profile of our products. Regulatory authorities examine these data to establish whether the benefits of a product outweigh potential risks and decide whether to approve the product for marketing.
After commercialization, we continue active surveillance to monitor for potential safety issues by conducting post-marketing studies using real-world data (RWD), continuously reviewing potential adverse event (safety) information and using advanced technologies to help respond rapidly and appropriately, in close partnership with regulatory authorities and other stakeholders, to issues that may arise.
We also develop risk management plans that are regularly reviewed and updated when additional safety information becomes available as more people use our products over a longer period of time. Where appropriate, we work with regulatory authorities to update product labels.
Last, but certainly not least, partnerships are an integral element of our approach to medical safety surveillance. We work closely with regulatory authorities, healthcare professionals, patient advocacy groups and leading research institutions to improve safety research, science and education.
Where do we get information for safety surveillance?
Our medical safety surveillance teams use many different kinds of data to ensure product quality and help us gain real-world insights on product performance and safety, including:
- Rigorous quality testing before our products leave our facilities to confirm that they are manufactured according to specifications.
- Review of quality issues to evaluate medical impact of a potential issue on patient and consumer safety, independent of commercial considerations.
- Post-marketing studies using RWD to continue to understand potential safety risks that might not have been evident in the initial clinical trials.
- Continuous review of potential adverse event (safety) information reported by hospitals, healthcare providers and patients, customer complaint data and other feedback for our Consumer segment products.
- Piloting and deploying advanced technologies, such as artificial intelligence and natural language processing for aggregating, integrating and analyzing real-world patient health outcomes for our portfolio of products.
Working with healthcare providers to ensure safe use of our products
We recognize we have an important role to play in ensuring healthcare providers using our products have the knowledge to use them safely.
For example, our Medical Devices Medical Safety group uses our Optimized Device Performance (ODP) tools to help physicians achieve optimized product performance and procedural outcomes when using one of our medical devices. Created based on post-market surveillance data and risk control documents, these tools focus on providing information about device usage and provide risk mitigation strategies if needed. Similarly, our Timely and Relevant Use-related Safety Training Support (TRUST-S) integrates ODP information into toolkits for healthcare practitioners during key product launches.