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Product Quality & Safety

Medical Safety

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Patient and consumer well-being is a priority in our decision-making and actions. The Office of the Chief Medical Officer (OCMO) leads medical safety globally at Johnson & Johnson, championing patient-centered, evidence- and science-based decisions across our three business segments. Our work is underpinned by a single medical safety standard, to which all our products are held.

See our positions and policies relating to patient safety:

In addition to our standards, policies and processes, our approach to medical safety is also informed by RWD RWD Real-world data View entire glossary to enhance our understanding of the safety and effectiveness of our medicines and medical devices outside clinical trial settings. In partnership with leading organizations, OCMO OCMO The Johnson & Johnson Office of the Chief Medical Officer View entire glossary is working to advance novel methodologies and tools for real-world data analysis to further inform clinical and regulatory decision-making and advance public health.

One of our Health for Humanity 2025 Goals reflects the growing importance of RWE RWE Real-world evidence View entire glossary in improving health outcomes.

2025 Goals

For full details of this Goal and KPI, see our Health for Humanity 2025 Goals.
Healthcare for Women
By 2025, publish insights into best-practice healthcare for women based on real-world data of one million women.

For full details of this Goal and KPI, see our Health for Humanity 2025 Goals.
For full details of this Goal and KPI, see our Health for Humanity 2025 Goals.

Organizations we regularly collaborate with and/or support to improve RWD RWD Real-world data View entire glossary and RWE RWE Real-world evidence View entire glossary methodologies and tools:

In September 2020, Johnson & Johnson joined the WHO and theInternational Alliance of Patients’ Organizations (IAPO) to bring attention to patient and health worker safety through World Patient Safety Day, and to increase public awareness and engagement, enhance global understanding, and spur global action to promote patient safety. Our OCMO colleagues participated as keynote speakers and panelists in IAPO’s annual Global Patients Congress.

In 2020, we further advanced medical safety for our diverse patients and consumers in innovative and collaborative ways, including:

Leveraging artificial intelligence for pharmacovigilance: We are advancing a first-in-kind AI capability to streamline pharmacovigilance processes for faster handling of complaint cases. At the Medicines and Healthcare Products Regulatory Agency (MHRA) Symposium 2020, Johnson & Johnson was recognized for our Literature Assist Tool, noting we are one of the few companies to demonstrate a first-in-kind AI capability in production and commending our unique intelligent automation strategy that includes both prescription and OTC products. The Literature Assist Tool, developed by Janssen R&D, leverages artificial neural networks and natural language processing to review scientific literature and identify safety cases, enabling faster complaint case processing with the capability to review hundreds of thousands of literature abstracts and articles each year. This technology reduces the burden of data entry from the labor-intensive literature review process, so that pharmacovigilance experts can focus on verifying data accuracy and ensuring the safety of drugs and products.

Improving maternal health outcomes: In partnership with the Center for Maternal Health Equity at the Morehouse School of Medicine, OCMO OCMO The Johnson & Johnson Office of the Chief Medical Officer View entire glossary convened the Georgia Maternal Health Research for Action Steering Committee, a group of clinical and academic experts in Black maternal health in Georgia, U.S.,19 which has one of the highest maternal mortality and morbidity rates in the United States. The Committee aims to provide guidance on an integrated suite of scalable programs to improve maternal health outcomes for Black mothers. We are conducting ethnographic research to understand the unique concerns and needs of Black mothers in Georgia during their pregnancy journey that will guide potential digital solutions to increase postpartum co-morbidity self-management and to promote early notification of postpartum complications.

Accelerating access to medicines for young patients: Typically, there is a small and widely dispersed pediatric patient population available for clinical trials, which presents a challenge in terms of assessing efficacy and safety of medicines for children. Utilizing existing databases to supplement pediatric clinical trial data can reduce drug development time by years. In 2020, OCMO championed the use of data extrapolation from adult clinical trials to seek a pediatric indication for SIMPONI ARIA (golimumab) in pediatric patients with arthritis. The submission was approved by the FDA, leading to a pediatric indication for SIMPONI ARIA, and accelerated access to this medicine to help children get the treatment they need faster.

Innovating to prevent accidental ingestions and medication errors in children: Child safety has always been a cornerstone of our medical safety work. Thousands of children are rushed to emergency departments every day due to accidental unsupervised ingestions. In 2020, we worked with JLABS JLABS Johnson & Johnson Innovation—JLABS View entire glossary to introduce the Pill Protect QuickFire Challenge: Designing for Medication Safety with support from the Scientific Education and Patient Advocacy, in coordination with the CDC CDC Centers for Disease Control and Prevention View entire glossary PROTECT Initiative. The best potential solution to prevent or reduce the accidental access by children to medications in pill dispensers will be announced in 2021 and receive up to $100,000 in grant funding, access to the global JLABS network, and mentorship from Johnson & Johnson experts.

Talc safety: We continue to address allegations that JOHNSON’S Baby Powder can cause adverse health effects. We sympathize deeply with cancer patients and their families and appreciate that they are seeking answers. However, the science and the facts show that their illnesses were not caused by their use of our talcum-based products. Our website includes independent studies from leading universities, research from medical journals and third-party opinions confirming that our talc is safe. Johnson & Johnson remains steadfastly confident in the safety of talc-based JOHNSON’S Baby Powder. Decades of scientific studies by medical experts around the world support the safety of our product. The facts are that JOHNSON’S Baby Powder is safe, does not contain asbestos, and does not increase the risk of cancer. In 2020, as a response to declining demand for this product, we discontinued sales in the United States and Canada.

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