At Johnson & Johnson, we recognize our fundamental responsibility is to provide patients, consumers and healthcare providers with products that are as effective and safe as possible. We take an evidence- and science-based, ethics- and values-driven approach to medical safety, putting patient and consumer wellbeing first and foremost in our decision making and actions, with an emphasis on transparency.
The Office of the Chief Medical Officer (OCMO) is an internal global team of medical and scientific professionals, including safety experts, from all three segments of Johnson & Johnson: Consumer, Pharmaceuticals and Medical Devices. Functionally independent from commercial and development portfolio interests, Johnson & Johnson’s OCMO focuses on the safety of our products through people-driven processes, initiatives and policies that are reinforced by a single medical safety standard, to which all our products are held.
Hear from Johnson & Johnson Chief Medical Officer Joanne Waldstreicher, M.D., on what makes the OCMO’s novel approach to medical safety different:
Proactive Safety Monitoring
Objective and proactive safety monitoring and evaluation is built into every stage of our product’s lifecycle—from development to post-launch.
At the development stage, we have formal processes involving committees of experts to provide governance and advisement. This includes our First-in-Human Committee responsible for reviewing all safety data before our novel products are used in people, and our Development Committees to assure that products will fill critical unmet healthcare needs. Day-to-day safety decisions are made by multi-disciplinary safety management teams, and more complex decisions are managed by sector Medical Safety Councils, which are chaired by the Chief Medical Officer responsible for each segment. 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.
We also have processes in place that outline the ethical treatment of trial participants and how to protect their health and safety, as well as an ethical code for the conduct of R&D.
After commercialization, we continue active surveillance to monitor for safety signals. We conduct post-marketing studies using real-world data (RWD), continuously review potential adverse event (safety) information, and use advanced technologies to help us respond rapidly and appropriately to issues arising, in close partnership with regulatory authorities and stakeholders.
Read more about our approach to proactive safety monitoring.
Championing eye health and safety
In 2018, Johnson & Johnson Vision joined the Health Care Alliance for Patient Safety as a Leadership and Charter member alongside the American Optometric Association to advocate for solutions to advance eye health, promote patient safety, and elevate the doctor-patient relationship.
We’re proud to join the Health Care Alliance for Patient Safety to promote key eye health issues and provide patients with the latest information they need to safeguard their health. Through the Alliance, we hope to bring attention to the untreated and, in some cases, undiagnosed vision conditions affecting millions of Americans today while also ensuring that eye health is a priority in our national health agenda.
Expanding clinical access for veterans
In 2018, we finalized a three-year agreement with the U.S. Department of Veterans Affairs (VA) to offer more veterans access to our clinical trials and pipeline therapies as well as help VA physicians stay current with the latest scientific advances. The VA’s 1,000 outpatient sites and 170 Medical Centers across the United States serve about nine million veterans, a patient population significantly impacted by diseases such as depression and cancer, which are important research areas of focus for Johnson & Johnson.
Giving cancer patients within the VA greater access to transformational clinical trials allows them to stay in the healthcare system most familiar to them and with the physicians who know them best.
The power of real-world data to enhance safety
We believe in the collective power of real-world observational data to complement clinical trial findings, and in sharing our insights to improve health outcomes.
To leverage the power of big data and analytics, we launched an open science collaborative with New York's Columbia University called the Observational Health Data Sciences and Informatics (OHDSI). OHDSI is a multi-stakeholder and multi-disciplinary open community of researchers working together to generate reliable evidence from observational data to promote better health decisions and better care. All findings, methodologies, analysis code and related software tools are shared publicly and published with free access to advance public health.
The OHDSI community comprises 60+ databases representing more than 1.2 billion patients in 20+ countries.
Leveraging big data to create a more transparent model for real-world data
Johnson & Johnson is also breaking new ground in the analysis of large RWD sets. In 2018, we analyzed data of more than 700,000 adults with type 2 diabetes across four large databases to evaluate comparative effects of seven diabetes medications or classes of medications on the risk of amputation and hospitalization for heart failure. The study, OBSERVE-4D, is the largest and most comprehensive real-world observational study to date, and established a new standard for quickly and appropriately translating large-scale RWD into evidence to complement evidence from clinical trials in an open and transparent manner.
Read more about how we are using RWD to improve health outcomes.
Supporting enhanced safety surveillance
Monitoring the safety of its regulated products is a major part of the U.S. Food and Drug Administration’s (FDA) mission to protect public health. Sentinel is the FDA’s national electronic system, which has transformed the way researchers monitor the safety of FDA-regulated medical products, including drugs, vaccines, biologics and medical devices. The FDA is currently exploring further research to enable increasingly proactive safety surveillance. In line with our commitment to collaborative development of innovative approaches to analyzing large volumes of safety data, we are supportive of this next phase of Sentinel. In December 2018, we shared our learnings and insights at an FDA-hosted multi-stakeholder open discussion to review methodologies and policies for enhancing proactive safety signal detection.
Enhancing the safety of pediatric medicine for children
Developing safe and effective medicines, devices and consumer products that enable future generations to reach their full potential requires child-centered innovation. The Child Health Innovation Leadership Department (CHILD) is Johnson & Johnson’s dedicated team working to understand the safety and effectiveness of our medicines in children, and to accelerate policies driven by the needs of our youngest patients.
In 2018, we co-led the development of connect4children (c4c), a six-year project to create a pan-European clinical trial network by 2024 to facilitate the conduct of pediatric clinical trials in the European Union. In collaboration with the Critical Path Institute (C-Path), we also co-led the creation of the Institute for Advanced Clinical Trials for Children (I-ACT for Children), an independent nonprofit organization that works collaboratively with parents, patients, investigators, foundations, regulators, other government agencies, biopharmaceutical sponsors and children’s networks to catalyze improvements in the quality and timely completion of global pediatric studies.
Children must have access to innovative medical therapies that have been developed with the same degree of urgency and rigor as those for adults. With connect4children in Europe joining in this effort, complementing work underway with I-ACT for Children in the United States, we will be able to accelerate the availability of high-quality scientific data that can improve the safe and effective use of therapies in children.
Medical safety driven by the needs of the people who use our products
Every action and decision we undertake is done through the lens of the patients and consumers who use our products every day. From patient-focused drug development, to using real-world evidence (RWE) most effectively to inform more personalized, safer healthcare decisions, to integrating the patient voice in safety management, we work to engage patients and consumers throughout the entire lifecycle of our products.
We also actively work with regulators to advance the use of patient-focused approaches to assess the benefit-risk balance of treatments. In 2018, we led the assessment and application of a novel methodology that captures quantitatively how patients evaluate benefit-risk tradeoffs, and were one of the first companies to successfully integrate patient preference assessments within clinical trials.
Collaborating to advance innovation in medical devices
Building on our work with the National Evaluation System for Health Technologies Coordinating Center (NESTcc), Johnson & Johnson is participating in five first-round test cases to lead the industry in gauging the feasibility of leveraging the NESTcc network to advance the use of RWE for medical device evaluation and regulatory decision making for better patient outcomes and care.
We believe real-world data will become an important part of ongoing safety in healthcare. For this to happen, each piece of evidence must be transparently understood and evaluated in conjunction with all the other evidence that is available.
Proactively enhancing medical devices safety in operating rooms
In 2018, we collaborated with Ariadne Labs, a joint center between Brigham and Women’s Hospital in Boston and the Harvard T.H. Chan School of Public Health, to promote and enhance training that emphasizes both the technical aspects of using a new surgical device and nontechnical aspects like communication, teamwork and decision making. This partnership created a device briefing tool (DBT) with the goal of increasing clinician confidence in using a new device and improving teamwork and communications in the operating room. After a successful 2018 pilot program in Thailand, Johnson & Johnson signed a 2.5-year agreement with Ariadne Labs to scale up and disseminate the WHO Surgical Safety Checklist and the DBT at key hospitals in Singapore, with the ultimate aim of global deployment.
Consumer products ingredient safety
We always use high-quality ingredients. We manufacture our products using pharmaceutical standards, which are higher than those mandated for personal care products or food. Additionally, we constantly look for purer versions of our ingredients and regularly incorporate them into our products. We continuously evaluate ingredients used in our products in response to consumer preferences, advances in science and our own scientific research. Our Consumer business segment leads consumer products ingredient safety through our Johnson & Johnson Global Ingredient Steering Committee, ensuring that ingredients are appropriately considered, using internal process assessments and external feedback. For more information, see our Safety & Care Commitment website.
At the end of 2018, we published a statement on our website and in the press to reassure our consumers that JOHNSON’S Baby Powder is safe, as a response to concerns relating to the presence of asbestos allegedly found in talc some years ago. Our statement confirms that the talc in our baby powder is pure, safe, pharmaceutical-grade talc and that we have always acted with transparency with the FDA and other regulators, giving full access to our testing results. We confirmed that there is overwhelming scientific evidence that our talc is safe and beneficial to use. Our website, www.factsabouttalc.com includes independent studies from leading universities, research from medical journals and third-party opinions confirming that our talc is safe.
Improved transparency for baby products
We’ve always been proud of the safety and gentleness of our baby products, but we also heard parents’ requests for fewer ingredients. In response to changing parent preferences, in 2018, we redesigned and began phased rollout globally of our JOHNSON’S Baby washes, lotions and haircare products, and reduced the number of ingredients in our portfolio by more than 50%, disclosing 100% of the ingredients in these products—including those found in fragrances.
While JOHNSON’S Baby products have been free from parabens, phthalates, 1,4-dioxane and formaldehyde-releasing preservatives since 2015, in this recent relaunch we removed dyes and sulfates from the washes, shampoos, lotions and creams, making them even gentler. Today, 96% of the ingredients in our washes, lotions and haircare products are naturally derived.33
JOHNSON'S fragrances are designed specifically for delicate and sensitive skin, so we design products to avoid harsh ingredients and well-known fragrance allergens. Our baby fragrances have been reviewed by both independent groups and safety experts—and for the first time are all listed on the JOHNSON’S website.