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 bioethical principles and people-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, supported by defined policies and processes. RWD RWD Real-world data enhances our understanding of the safety and effectiveness of our medicines and medtech products outside clinical trial settings. In partnership with leading organizations, OCMO advances novel methodologies and tools to further inform clinical and regulatory decision making and advance public health.
Health for Humanity 2025 Goals | Accountability & Innovation
1. Maternal health racial equity.
2. Sex as a biologic variable, as women have traditionally been underrepresented in medical research.
Our Healthcare for Women 2025 Goal reflects the growing importance of RWD in improving health outcomes.
Supporting healthcare for women: OCMO’s Health of Women and Global Epidemiology teams came together in 2021 to establish the Johnson & Johnson Pregnancy and Lactation Advisory Group (JJ-PAL). With the knowledge that pregnant and lactating women are historically understudied, we saw the need for a dedicated effort to provide guidance to clinical teams in characterizing the benefit-risk profile of products used during pregnancy and lactation. JJ-PAL now advises clinical development teams as they envision evidence-based activities in pregnant and lactating women. Guidance provided to several teams has resulted in updates to protocols, regulatory strategy or amendment of clinical study documents.
Improving maternal health among Black mothers: In alignment with our ambition to improve maternal health equity (see section: Our Race to Health Equity), OCMO OCMO The Johnson & Johnson Office of the Chief Medical Officer continues to foster multistakeholder collaborations with academic institutions, policymakers, community organizations and Black mothers in the U.S. state of Georgia to advance maternal health equity. This new public–private collaborative approach engages more than 25 organizations and supports Black researchers and community groups who are leading these important projects. We also partnered with Accenture, Microsoft and the Healthy Mothers Healthy Babies Coalition of Georgia to initiate Hack4Equity, a hackathon that convened 250 innovators to crowdsource solutions to address maternal morbidity and mortality. Three awardees received expert technical support and funding to advance their proposed solutions that included providing quality education and access to care for expectant mothers and an app to match mothers with certified doulas and other resources such as childcare and transportation.
Ongoing medical safety excellence during COVID-19: Among our highest priorities during the pandemic have been uninterrupted and effective monitoring and ongoing safety evaluation of our products. Advanced methods and tools were developed by OCMO epidemiology teams as part of our COVID-19 vaccine safety surveillance program. The tools included rapid analysis of RWD RWD Real-world data to complement vaccine safety information from clinical trials and spontaneous case reports once the vaccine became available to the public. These analyses improved our ability to respond more rapidly to potential safety signals and manage the benefit–risk profile of the vaccine to help keep people as safe as possible. OCMO also co-led efforts to maximize the use of modeling of the regional spread of the pandemic to identify those at the highest risk of COVID-19, including diverse populations, to aid in clinical trial recruitment with representation of those at the highest risk of severe disease.
Focusing on child safety: We advanced initiatives focusing on the safety of older children who may be self-medicating and younger children who are at risk of accidental unsupervised ingestions of medicine.
- OCMO and our Consumer Health teams partnered with Scholastic to develop a cross-curricular program and platform with educational resources to teach youth about OTC medicine safety.
- We partnered with the nonprofit organization Safe Kids Worldwide to implement a medication safety program providing research and practical tools and tips for parents about the safe storage and dosing of medicine.
- We announced the awardee of the Pill Protect QuickFire Challenge: Designing for Medication Safety, which we introduced with JLABS with support from the Scientific Education and Patient Advocacy and in coordination with the CDC PROTECT Initiative.
Promoting patient preference studies: We are co-leading the Innovative Medicines Initiative PREFER project, a five-year project to establish recommendations for industry regulatory authorities and Health Technology Assessment bodies on the use of patient preferences in medicinal product decision making. PREFER is providing the pharmaceutical, medical device and vaccine industries with recommendations for framing decisions based on patient preference studies. Patient preference studies are a dynamic field with considerable ongoing methodological research and numerous questions that must be addressed for regulatory applications. The methods involved in preference studies are technically complex and still novel for many in healthcare and medical treatment development, making the PREFER initiative a crucial one for leveraging the patient voice to improve health outcomes. The PREFER framework and recommendations are expected to be qualified by European regulators, providing official recognition of PREFER’s patient preference study framework. Johnson & Johnson co-defined PREFER, serves on its steering committee and leads several key components of the project.
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. Please see factsabouttalc.com and LTLManagementinformation.com for information on the safety of talc and steps taken to equitably resolve all talc claims. Johnson & Johnson remains steadfastly confident in the safety of talc-based JOHNSON’S Baby Powder.