Medical Safety

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 well-being first and foremost in our decision making and actions.

The Office of the Chief Medical Officer (OCMO) is a global, functionally independent group of medical and scientific professionals working across Johnson & Johnson to guide excellence in product safety and development across our three business segments. We apply our expertise in safety science, epidemiology and bioethics to inform evidence- and science-based product decisions that put people first. OCMO also chairs the Pharmaceutical Development Committee, which reviews product development plans to ensure that our products address unmet needs and benefit the people who will ultimately use them.

Our Healthcare for Women 2025 Goal reflects the growing importance of RWD in improving health outcomes.

Health for Humanity 2025 Goals

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Progress in Healthcare for Women

Achieved publication in nine original publications of insights based on real-world data points representing more than 27 million women, with a research focus in two main areas:

1. Maternal health racial equity.
2. Sex as a biologic variable, as women have traditionally been underrepresented in medical research.

Primary contributing publications include the following studies: New Jersey maternal mortality dashboard: an Interactive social-determinants-of-health tool (27 million+ data points representing female residents) and Sex differences in sequelae from COVID-19 Infection and in long COVID Syndrome: a review (600,000+ female participants).

Exceeded

OCMO, in collaboration with many internal and external groups, advanced multiple initiatives to improve medical safety, including innovative RWD methods to generate reliable real-world evidence about patient health outcomes across numerous initiatives spanning pharmaceutical products, vaccines, medical devices and Consumer Health products. Highlights of this work in 2022 include:

Improving access to critical medical devices using RWD

We conducted RWD studies to inform clinical and regulatory safety decision making in two key areas: evaluating the safety of our TFN-ADVANCED Proximal Femoral Nailing System compared to other nail implants to treat hip fractures and evaluating the potential risk of cancer and reproductive issues associated with cobalt-containing devices. Our work in both areas generated extensive evidence of comparative safety of both TFN-ADVANCED and cobalt-containing products being confirmed as safe to use in patients, which we supported with the publication of six papers in peer-reviewed journals to drive transparency among patients, surgeons and regulators. These studies are important to provide information on the safety and effectiveness of these devices, which provide life-changing healthcare for thousands of patients in different parts of the world.

Advancing the safety of children

The safety of children has always been a priority for Johnson & Johnson in R&D and across our OTC medicines. Achievements in 2022 include:

• Treatment for children suffering from active psoriatic arthritis (PsA): OCMO’s Child Health Innovation Leadership Department (CHILD) supported Janssen’s clinical development team in the design and execution of a pediatric safety study to evaluate the safety of a new treatment option for pediatric patients with active PsA. The generated data, now in our label, supported a much-needed treatment option to enable children suffering from PsA to live a fuller life.
• Spearheading medication safety and education: Health education programs can help families protect small children from accidental unsupervised ingestion of medicines, a frequent occurrence that often requires emergency treatment. In 2022, OCMO collaborated with Young Minds Inspired to develop educational resources to teach youth about OTC medicine safety, worked with the nonprofit Safe Kids Worldwide to implement a medication safety program with tools and tips for parents about safe storage and dosing of medicine and continued to advance safe pill storage innovation in collaboration with the CDC PROTECT Initiative and QuickFire Challenge Awardee Gatekeeper Innovation Inc. The winning QuickFire Challenge concept, which reinvented the traditional pill minder for improved safety, functionality and patient adherence, is anticipated for commercialization in 2023.

Promoting maternal health

OCMO supported the advancement of maternal health and maternal health equity in the U.S. through continued guidance to clinical teams in conducting evidence-generation activities that include women, as well as pregnant and lactating women, and collective action to close the Black maternal health equity gap. Through this work, we are accelerating sex-disaggregated data, uncovering insights that can improve care and outcomes for women and offering evidence so that pregnant people and their providers can make informed decisions about the safe use of Johnson & Johnson products. Recent examples include:

• Accelerating women-centric science by further shifting from sex-biased to more sex-inclusive science and data to provide treatment and innovation that is specifically tailored for women. OCMO collaborated with different groups within Johnson & Johnson to provide sex-differentiated analyses on immunologic, neurologic and other conditions to understand the experiences that men and women have and how altering the approach to treatment might enhance the health of both sexes. Through our Healthcare for Women Health for Humanity 2025 Goal, we delivered nine publications that provide sex-differentiated analyses for long COVID, psoriasis and other conditions.
• Advancing pregnancy and lactation science through the Johnson & Johnson Pregnancy and Lactation Advisory Group (JJ-PAL), composed of experts across 14 functions to support the planning of evidence-generation activities in pregnant and lactating people. JJ-PAL progressed in several areas in 2022, including nine internal consultations to product teams to help improve designing and interpreting evidence related to safe use of medication during pregnancy or lactation; delivering a searchable inventory of global RWD sources for studying medication use during pregnancy and lactation; co-chairing a National Academy of Science, Engineering, and Medicine Workshop to facilitate inclusion of pregnant and lactating people in clinical research; and initiating a survey of pregnant, postpartum and lactating persons in the U.S. to better understand opportunities for increased inclusion of pregnant and lactating people in clinical trials.
• Improving maternal health outcomes for Black women through several activities that included initiating an effort to design a care model that reimagines the role of the front office staff as patient connectors, advocates and critical members of the care team; initiating an effort to elevate representation of Black people in medical illustrations; and continuing to advance multiple pilot projects to investigate the creation of digital tools to help advance maternal healthcare services for Black women and birthing people.

Enhancing the patient voice in clinical 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 how and when to use patient preferences on benefits and risks of medicinal products in decision making. Johnson & Johnson serves on the PREFER steering committee, and in 2022, we closely supported two achievements:

• PREFER released a detailed framework and recommendations for industry, regulators and health technology assessment bodies on the assessment and use of patient preferences in medical product decision making.
• The PREFER framework received formal qualification from the EMA and the European Network for Health Technology Assessment (EUnetHTA).

The EMA qualification of the PREFER framework is significant because it will enable a more explicit pathway for stakeholders to engage with the EMA on conducting patient-focused, structured benefit-risk assessments. It will also help to grow the acceptability of such studies as part of clinical and regulatory decisions around the world.

Talc safety

We continue to address allegations that JOHNSON’S Baby Powder can cause adverse health effects. We sympathize deeply with 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. For more information, please see factsabouttalc.com.

Talc transition

In 2022, Johnson & Johnson Consumer Health made the commercial decision to transition to an all cornstarch-based baby powder portfolio as part of a larger portfolio assessment. As a result of this transition, talc-based JOHNSON’S Baby Powder will be discontinued globally in 2023.