Access to Health

Research & Development

Product &
Patient Safety

Product &
Patient Safety
Research & Development
Main

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 clinical trials before they are approved. Learn more about our clinical trials.

Our company’s new chief medical officer, Roy Baynes, MD, PhD, 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 authority over the design, execution and implementation of expanded access (“compassionate use”) programs.

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. The center can assist you Monday through Friday from 8 a.m. to 7 p.m. Eastern time. Adverse experiences and product-related emergencies can be reported at any time by dialing 800-444-2080.

Our company’s Global Safety function manages a global system for the collection, management and reporting of adverse experience (AE) reports received by our company worldwide. Learn more.

Monitoring & Compliance

The Good Clinical Practice: Process Technology and Vendors (MRL QA GCP-PTV), Good Clinical Practice: Investigator Sites, Country Operations and Partners (MRL QA GCP-ISCOP) and Pharmacovigilance (MRL QA PV) functions are part of our company’s Quality Assurance Organization. This group is responsible for conducting independent, periodic audits of the processes, computerized systems, technology and collaborative partners supporting the Human Health and Animal Health divisions within our company.

The MRL QA GCP/PV audit program is a comprehensive, risk-based audit and oversight program that encompasses a broad range of assessments as listed below:

  • Clinical investigator sites: Audits to assess compliance with the protocol and with relevant global and local regulations/guidance (e.g., GCP & PV regulations)
  • Collaborative partners: Pre-contractual assessments and selected post-contractual audits of contracted research organizations (CROs), central laboratories and other third-party business partners and vendors
  • Computerized systems and technology: Audits and assessments of the relevant computerized systems and technology
  • Internal process/systems audits: Systematic evaluations of adherence to relevant internal policies, Standard Operating Procedures and guidelines as well as applicable global and local regulations/guidance
  • Country operations audits: Periodic and systematic assessments of our company’s activities carried out by our subsidiaries worldwide
  • Business partner audits: Audits of external companies with which a licensing or development agreement exists where compliance with contractual and regulatory requirements is assessed
  • Verification audits: Audits to verify the effectiveness of corrective actions

Through the oversight and implementation of this comprehensive audit program, MRL QA provides independent assurance to our company’s senior management that the operations, processes, and computerized systems and technology supporting our Human Health and Animal Health development activities comply with applicable global and local regulations and guidelines as well as internal company policies and procedures.

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 formation 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 health outcomes of interest (HOIs) identification and evaluation, 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, 2016, our company’s Pharmacoepidemiology and Database Research Unit has successfully created and utilized 30 SafetyMatters Disease Cohorts in 18 product-specific areas. 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.

Innovative Medical Evidence Development and Surveillance (IMEDS): The Innovative Medical Evidence Development and Surveillance (IMEDS) program is a partnership between the Pharmaceutical Research and Manufacturers of America (PhRMA), academia and the FDA. The IMEDS program is a public-private partnership created to build upon the significant progress made on research methodology by the FDA’s Sentinel Initiative, including its Mini-Sentinel pilot. IMEDS’s primary objective is to advance the science and tools necessary to support post-marketing evidence generation on regulated products, including safety surveillance and evaluations, and to facilitate utilization of a robust electronic health care data platform for generating better evidence on regulated products in post-marketing settings.

Our company supports IMEDS through participation in the Observational Health Data Sciences and Informatics (OHDSI) program, dedicated to advancing pharmacoepidemiology methods development for distributed database systems, and through representation on the Scientific Advisory Committee of IMEDS. We 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 begins in Phase I in a small number of people and progresses through Phase III, during which the safety and efficacy of a medicine is rigorously evaluated. If the clinical studies are successful, 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. Even after a product is approved, we continue to actively monitor the safety of our medicines and vaccines in various ways, including 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

Our 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 U.S. Outside the U.S., adverse events are reported according to local laws and practices.

Depending on label changes and their context, we may determine, in consultation with regulatory agencies, that more extensive communications may be 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 Doctor” letters and media releases.

Adverse Event Reporting

Global Safety manages a global system for the collection, evaluation and reporting of adverse experience (AE) reports received by our company worldwide.

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. The center can assist you Monday through Friday from 8 a.m. to 7 p.m. Eastern time. Adverse experiences and product-related emergencies can be reported at any time by dialing 800-444-2080.

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 developed a written procedure to provide personnel worldwide—including all contractors—with a consistent and thorough process for identifying, evaluating and reporting AEs occurring in association with the use of our products. These procedures cover the reporting of AEs originating in clinical studies and those associated with the use of marketed products. Adherence to these procedures ensures timely and accurate monitoring of the safety profile of our investigational and marketed products globally.

To report an adverse experience to regulatory authorities, we need at least minimal information: the name of the product involved, the adverse experience, an identifiable patient and an identifiable reporter. In addition to submission of individual AE reports to regulatory authorities, either within 15 calendar days or periodically, we also file aggregate reports either quarterly, twice a year or annually, for as long as we market a product.

Our Risk Management & Safety teams review adverse experience information received from all sources (foreign, domestic, clinical trials, published literature, post-marketing) for our products and determine what actions may need to be taken with reference to the evolving safety profile of our 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 Safety 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 monitoring and reporting adverse experiences undergo rigorous training every other year. New employees within our research laboratories—including all contract personnel—working in areas related to clinical research and global safety undergo training on our AE policies and procedures when they join the company. All other employees are trained in AE reporting procedures as part of our Code of Conduct training.