At Johnson & Johnson, we recognize our fundamental responsibility to provide patients, consumers and healthcare providers with products that are as effective and safe as possible. We want our medicines and products to deliver maximum benefits with minimal avoidable harm. Driven by ethical considerations that stem from Our Credo, and led by our functionally independent medical safety organization, we take a science- and evidence-based approach to medical safety, putting patient and consumer well-being first and foremost in our decision-making and actions.
Safety governance is overseen by our Office of the Chief Medical Officer (OCMO), a global organization that brings together multi-disciplinary teams of safety experts across all three business segments with backgrounds in safety science, including medicine, epidemiology, pharmacology, bioethics and product vigilance. Functionally independent from commercial as well as R&D interests, OCMO established a single safety standard to which all our products are held, and which guides our end-to-end safety management strategy. OCMO is also responsible for the development and execution of our medical ethics policies and programs, clinical data sharing and transparency, and our initiative in expanded access to investigational medicines.
Safety monitoring is built into every stage of product lifecycles, starting at early discovery phase with target identification in the Pharmaceutical business and with evaluations of new ingredients for our Consumer products. Pre-clinical and clinical testing, trials and registries play an important role in the development and post-launch monitoring of medicines, vaccines and medical devices. We have processes in place that outline the ethical treatment of trial participants and how to protect their health and safety. For more information, see our Statement on Conducting Clinical Trials.
Before each product launch, our R&D groups submit all required information to national regulators for their review; this may include results of clinical trials and other documentation describing the safety and efficacy profile of the product. The regulatory authorities examine these data to establish whether the benefits of a product outweigh potential risks, and decide whether or not to approve the product for marketing.
After commercialization, we continue active surveillance to monitor for safety signals, and respond rapidly and appropriately when any issues are identified. We do this in close partnership with regulatory authorities and stakeholders across the globe. We identify and track safety data from many sources, including the following:
- Rigorous quality testing is done by our Quality organization at the manufacturing phase—before our products even leave our manufacturing facilities—to ensure that products are manufactured according to specifications. Review of quality issues that have potential safety implications involves members of medical safety teams in each operating company to evaluate medical impact of that issue on patient and consumer safety, independent of commercial considerations.
- Post-marketing studies are conducted for medicines and devices that involve larger and more diverse patient populations to continue to understand potential safety risks, particularly those that might not have occurred in the initial clinical trial populations.
- We continuously monitor and review potential adverse event (safety) information reported by hospitals, healthcare providers and patients, as well as collect and review 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.
For all our Consumer, Medical Devices and Pharmaceutical products, we develop risk management plans that are regularly reviewed and updated when additional safety information becomes available, with more people using our products over a longer period of time. Where appropriate, we liaise closely with regulatory authorities to update the label for patients and healthcare practitioners.
Partnerships are an integral element of Johnson & Johnson’s Safety Vision. Throughout our safety surveillance activities, we work closely with regulatory authorities, patient advocacy groups and leading research institutions to improve safety data, science and education. Most recently, we collaborated with Ariadne Labs, a collaboration between Brigham and Women’s Hospital in Boston and the Harvard T.H. Chan School of Public Health, to promote and increase medical device safety awareness among surgeons and other healthcare professionals around the world. In 2017, we signed an agreement with Ariadne Labs to pilot a training program in Bangkok, Thailand, to educate surgeons and nurses on safe use of medical devices.
To leverage the power of big data and analytics, Johnson & Johnson is an active leader within Observational Health Data Sciences and Informatics (OHDSI). OHDSI is an open science collaborative that aims to improve health by empowering a community to work together on generating reliable evidence from observational data to promote better health decisions and better care. OHDSI is a multi-stakeholder and multi-disciplinary community of researchers, and has established an international data network to provide opportunities for large-scale observational research and analysis. All results and solutions are shared and published to advance real-world data monitoring for the benefit of healthcare professionals and patients. Analysis code and related software tools are all made publicly available on the OHDSI website.
Specific to the assessment of medical devices, Johnson & Johnson participates in the Medical Device Epidemiology Network and the National Evaluation System for Health Technology, multi-stakeholder efforts involving the U.S. Food & Drug Administration and others. Both of these efforts are aimed at building the infrastructure needed to conduct rapid and efficient evaluations of specific medical devices using existing data sources. Preliminary work has demonstrated that existing registries linked to other data sources, such as health insurance claims, can produce data supporting label changes more quickly and with larger numbers, compared with traditional post-market studies.
Engaging Patients in Safety and Clinical Research
Patients and consumers are at the center of our safety surveillance activities. As increasingly active owners of their own healthcare journeys, patients and their caregivers are well-positioned to provide unique insights into our product R&D processes. We engage patients and seek to integrate their input throughout all stages of a product lifecycle, from development to commercialization. Our collaborative work with the National Academies of Sciences, Engineering and Medicine (NASEM), the NASEM Patient Engagement Project, aims to foster development of a strategic research agenda to advance the science of the patient voice and identify ways in which patients can inform product benefit/risk intelligence.
Our Pharmaceutical R&D group integrates the insights of patients into our clinical trials, and in 2017 launched a Patient Voice initiative. This effort will help inform and improve our clinical trial designs by sharing clinical trial plans with patients, gathering patient feedback on protocols, and modifying clinical trial design, recruitment and retention – crucial factors in the successful execution of robust clinical trials that evaluate whether a new medicine can have a meaningful impact.
Consumer Products Ingredient Safety
We recognize that people around the world, particularly those who use our personal care products, are increasingly interested in cosmetic ingredient safety. We continuously evaluate the ingredients used in our products in response to consumer preferences, advances in science and our own scientific research. Understanding and engaging with key stakeholders, such as consumers, health authorities and academics, is a crucial component of this process.
Johnson & Johnson's ingredient governance process, led in our Consumer business segment through the Johnson & Johnson Global Ingredient Steering Committee, requires that every ingredient we use have its own unique strategy. Our enterprise-wide management process is grounded in the following framework:
- Internal processes: Ingredients are governed by a Standard Operating Procedure, which provides a formal worldwide process for ingredient policies; the Johnson & Johnson Ingredients Working Group consists of internal experts reviewing ingredient advancements on a monthly basis.
- External input: Johnson & Johnson searches for the earliest signal(s) from external partners to strengthen internal polices and positions.
- Strategic Assessments: The Johnson & Johnson Global Ingredient Steering Committee is responsible for setting individual ingredient strategies, working with regional partners across Consumer segment and enterprise functions, including the R&D and Medical Safety teams, Environment, Health, Safety & Sustainability, Regulatory, and others.
For more information on consumer product ingredient safety visit our Safety & Care Commitment website