Product & Patient Safety

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 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 before marketing them. 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 benefit/risk 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 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.

MONITORING & QUALITY ASSURANCE

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, Clinical Supply, Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Pharmacovigilance Practice (GVP), Technology Vendor and Processes (TVP) and Global Medical Affairs (GMA).

MRL QA is also responsible for creating and carrying out a comprehensive, risk- based audit strategy that encompasses a broad range of assessments including, but not limited to, clinical investigator sites, country operations, third-party vendors and business partners, computerized systems and technology, and internal process/system audits.

MRL QA is responsible for monitoring and maintaining the MRL Quality Management System, which includes assessing the strength of our company’s pharmacovigilance system.

CLINICAL SAFETY & RISK MANAGEMENT

Clinical Safety and Risk Management (CSRM) leads the Risk Management & Safety teams for all products, from the beginning of Phase IIb through the end of the product life cycle. CSRM is responsible for the development of a proactive clinical safety risk-management strategy, including the Risk Management Plan, which is a regulatory requirement in many countries for marketed drugs and vaccines.

Development of the overall risk-management strategy incorporates all available internal information (e.g., basic research data and animal and human studies with the product and/or related products) and external information (e.g., literature and public data related to the class of drugs and/or therapeutic target) that contribute to the overall risk-benefit assessment of the product. The strategy focuses on activities needed to identify, evaluate and manage potential patient-safety risks. The Risk Management & Safety teams address patient safety using product labeling, physician and patient educational programs, and other risk-minimization strategies, as appropriate. The Risk Management & Safety teams also implement strategies to determine the effectiveness of these interventions, as appropriate.

SafetyMatters Initiative: The goal of our company’s SafetyMatters Initiative is to explore and implement the appropriate use of emerging technologies and methods for the identification and evaluation of health outcomes of interest (HOIs), and to further improve post-licensure monitoring and evaluation of our marketed products. A cornerstone of SafetyMatters is the proactive development and utilization, as needed, of disease cohorts (i.e., groups of patients identified as having specific conditions of interest) based on data contained in large medical claims and electronic health-record databases licensed by our company.

As of May 1, 2018, our company’s Pharmacoepidemiology and Database Research Unit had successfully created and utilized 30 SafetyMatters disease cohorts in 18 product-specific areas. The proactive development of these cohorts greatly facilitates our ability to effectively and promptly respond to many internal or external inquiries about the epidemiology of these diseases and their treatment.

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 Risk Management & Safety teams to develop or update product labeling. We communicate relevant information regularly to regulatory agencies worldwide.

Innovation in Medical Evidence Development and Surveillance (IMEDS): The IMEDS program is a public-private partnership within the Reagan-Udall Foundation for the Food and Drug Administration (FDA). The aims of IMEDS are to advance the science and tools necessary to support post-marketing evidence generation on regulated products, including safety surveillance and evaluations, and to facilitate the utilization of a robust secondary electronic health care data platform for generating better evidence on the safety and effectiveness of regulated products in post-market settings. Partners in IMEDS include the FDA, pharmaceutical companies, academia and patient organizations.

Our company supports IMEDS by providing an annual grant as a founding member to support its mission as well as through representation on the Scientific Advisory Committee of IMEDS. In 2018, we signed a Confidential Disclosure Agreement (CDA) with IMEDS to explore the use of the FDA Sentinel Data System for a safety study. We will continue to explore synergies and linkages between IMEDS and our own SafetyMatters Initiative to establish standards for the use of modern epidemiology data sources and analytic techniques for evaluating product safety in observational claims and electronic health-record databases.

PRODUCT SAFETY

We rigorously study our products, and work with regulators and health care professionals over many years to characterize their safety profiles. Initially, test compounds are evaluated in the laboratory. If they pass stringent laboratory tests, the compounds move into next-stage testing in animals. Only a few compounds ever make it that far. If the compound 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 compound 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, we submit extensive documentation and data to regulators in a product-licensing application. Before approving a medicine or vaccine for use, regulators scrutinize these extensive data and analyses. Active safety monitoring of our products continues after approval, including through post-marketing studies. If we identify safety issues following a product’s approval, we work closely with the regulatory authorities to communicate promptly and appropriately with health care professionals and patients.

COMMUNICATING ABOUT PRODUCT RISKS

The information leaflets in our product packaging contain information on possible side effects and, if appropriate, how to avoid some potential 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 global and any additional local laws and practices.

Depending on label changes and their context, we may determine, in consultation with regulatory agencies, that more extensive communications are appropriate. In such cases, we work with regulatory authorities to contact health care professionals in a timely manner, so that they can communicate these findings to patients through appropriate mechanisms. Contacting health care professionals might include “Dear Health Care Provider” letters and media releases.

Adverse Experience Reporting

Global Pharmacovigilance manages a global system for the collection, evaluation and reporting of adverse experience (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.

REPORTING AN “ADVERSE EXPERIENCE” IN THE U.S.

To speak with one of our health care professionals about our company’s products, or to report an adverse experience with a specific product, please call our company’s National Service Center at 800-444-2080 in the U.S. The Center can assist you Monday through Friday from 8 a.m. to 7 p.m., Eastern Time.

In accordance with global regulatory reporting requirements, we have a written procedure and associated training 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 both 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.

Our Risk Management & Safety teams review adverse experience information received from all sources (foreign or domestic, clinical trials or published literature, or post-marketing) for our products and determine what actions may need to be taken with reference to the evolving safety profile of those products. These teams include physicians and epidemiologists who are trained to review this type of data.

It can be difficult to determine the exact cause of an adverse experience because many patients have more than one condition and may be taking multiple products. Our Global Pharmacovigilance staff takes great care to make sure that AE reporting is as accurate as possible. We review the data to determine if there are any patterns or emerging trends that need additional surveillance or action.

Employees responsible for reporting and monitoring adverse experiences undergo rigorous training. New employees within our research laboratories and Human Health division, including all contract personnel, undergo training on our AE policies when they join the company and annually thereafter. Individuals dealing with clinical research and safety analysis and communication undergo further specialized training. All other employees are trained in AE reporting procedures as part of our Code of Conduct training.