Product & Patient Safety
We recognize that when people take our medicines and vaccines they must have confidence in their efficacy and safety.
Our company’s Center for Observational and Real-World Evidence (CORE) group launched the Real World Data Exchange (RWDEx), a state-of-the-art, cloud-based data warehousing and analytics platform designed to transform how we manage, analyze and share RWD evidence.
Our company’s medicines and vaccines are widely tested before they are approved for marketing. This testing is governed by a comprehensive regulatory scheme and by our research policies. We assess the safety of our products in rigorous nonclinical and clinical trials prior to seeking regulatory approval. Following approval of our drugs, vaccines or devices, the company continues to monitor their safety profiles. Learn more about our clinical trials.
Our company’s chief medical officer holds overall responsibility for the benefits and risks of our pipeline and marketed products, provides medical oversight for all clinical programs, supervises the development and implementation of medical policies (including those related to data transparency and the sharing of clinical data), and has responsibility for the design, execution and implementation of pre-registration expanded access (“compassionate use”) programs.
Our company’s Global Clinical Safety and Pharmacovigilance (GCS&PV) function manages a global system for the collection, review and reporting of Adverse Experience (AE) reports received by our company worldwide, and for the continuous assessment of product safety. Our company’s chief safety officer holds overall responsibility for the safety of our products.
Safety and quality assurance
MSD Research Labs (MRL) Quality Assurance (QA) provides independent oversight to assure subject safety and research integrity throughout the drug development life cycle. The scope of the MRL QA oversight function includes Animal Welfare, Global Development Quality/Good Manufacturing Practices (GMP), Regulated Laboratory Research/Good Laboratory Practices (GLP), Clinical Research/Good Clinical Practices (GCP), Good Pharmacovigilance Practice (GVP), Technology Vendor and Processes (TVP), Regulatory Affairs, Global Medical & Scientific Affairs (GMSA), and the Center for Observational & Real-World Evidence (CORE).
Clinical safety and risk management
Clinical Safety and Risk Management (CSRM) leads the Risk Management & Safety Teams (RMSTs) for all products, from the beginning of Phase 2b through the end of the product life cycle. CSRM is responsible for the development of proactive clinical safety risk-management strategies, including the Risk Management Plan, which is a regulatory requirement in many countries for marketed drugs and vaccines.
We rigorously study our products, and work with regulators and health care professionals over many years to describe their safety profiles. Initially, test candidates are evaluated in the laboratory. If they pass stringent laboratory tests, the candidates move into next-stage testing in animals. Only a few candidates ever make it that far. If the candidate makes it through the animal-testing stage, we then begin clinical development, during which multiple studies are conducted over several years.
Clinical testing initially involves the detailed analysis of the effects of a test agent in small numbers of people including evaluation of dose levels. In subsequent trials, the safety and efficacy of a therapeutic candidate are rigorously evaluated in increasingly large clinical studies. If the clinical studies provide evidence of benefit that outweigh the risks, we submit extensive documentation and data to regulators in a product-licensing application. Active safety monitoring of our products continues after approval, including, in certain instances, through post-marketing studies. If we identify safety issues following a product’s approval, we work closely with regulatory authorities to promptly and appropriately communicate with health care professionals and patients.
Communicating about product risks
The label in our product packaging contains information on possible side effects and, if appropriate, how to avoid some potential health problems. We include contact details on our corporate website for patients, caregivers and health professionals to report adverse experiences in the United States. Outside the United States, adverse events are reported in accordance with any additional local country laws and practices.
Depending on label changes and their context, we may determine, in consultation with regulatory authorities, that more extensive communications are appropriate. In those situations, we work with regulatory authorities to communicate to health care professionals in a timely manner so that they can inform patients through appropriate mechanisms. Communications to health care professionals may include “Dear Health Care Provider” letters and media statements.
Adverse experience reporting
Global Pharmacovigilance manages a global system for the collection, evaluation and reporting of AE reports received by our company worldwide.
Although regulations vary by country, most countries require drug manufacturers to promptly review AE information they receive from any source, domestic or foreign, relating to the use of their products. Manufacturers are also required to have written procedures in place for evaluating and reporting adverse experiences.
In accordance with global regulatory reporting requirements, we have written policies and procedures to provide personnel worldwide (including all contractors) with a consistent and thorough process for identifying and reporting AEs occurring in association with the use of our products. Additional detail is provided in procedures covering the reporting of AEs originating in clinical studies and those associated with the use of marketed products, and the analysis of these events for safety issues. Adherence to these procedures ensures timely and accurate monitoring of the safety profile of our investigational and marketed products globally.
In addition to the submission of individual AE reports to regulatory authorities in accordance with global and local timelines, we also produce development and post-marketing aggregate safety reports as required by global regulations or local regulatory authorities, for as long as we develop and market a product, for submission to regulatory authorities.
All employees, including contractor personnel worldwide, are required to complete AE, Product Quality Complaints and Other Reportable Safety Information training when hired, and annually thereafter.
Programs and initiatives
Real World Data Exchange (RWDEx)
In 2019, our company’s Center for Observational and Real-World Evidence (CORE) group launched the Real World Data Exchange (RWDEx), a state-of-the-art, cloud-based data warehousing and analytics platform designed to transform how we manage, analyze and share RWD (Real World Data) evidence. This integrated information technology platform and its associated data management and analytic software facilitates the ability of our scientific and business personnel to discover RWD, investigate and collaborate.
The design and ongoing implementation of the RWDEx is a multidisciplinary collaborative effort within our company and is coordinated by the Economic and Data Sciences (EDS) and Pharmacoepidemiology (PE) departments within CORE. This new platform will facilitate all manner of observational data applications, including our ability to continue to respond quickly and effectively to drug safety issues as we remain ever-vigilant to the evolving safety profile of our products in actual clinical use.
Product label reviews
The ongoing oversight and monitoring of our product labels are a major focus of our safety efforts. Our label review teams monitor information on our products and work with our product RMS teams to develop or update product labeling. We regularly communicate relevant information to regulatory authorities worldwide.
Innovation in Medical Evidence Development and Surveillance (IMEDS)
In July 2018, an agreement with the Reagan-Udall Foundation for the FDA was signed to use the Innovation in Medical Evidence Development and Surveillance System (IMEDS) Distributed Database (IMEDS-DD), a subset of the FDA Sentinel Distributed Database, to conduct an EU-required post-approval safety study (PASS).
Such PASS studies are currently required for all Marketing Authorization Holders of drugs in the sodium-glucose co-transporter-2 inhibitor class. IMEDS provides a framework for private-sector entities (e.g., regulated industry, academic institutes) to leverage the FDA Sentinel Distributed Database. The study is expected to complete by 2023.