Safeguarding Our Patients and Our Employees
At Celgene, we take special care to ensure patients’ safe access to our treatments. We have developed unique, industry-leading programs under which hundreds of thousands of patients worldwide have accessed the clinical benefits of our therapies.
• Educational materials for healthcare professionals to ensure the correct and safe use of our drugs
• Constant and professional attention to patient needs
• Extremely careful monitoring of the use of our products to ensure patients can benefit from Celgene’s innovative and life-enhancing therapies
Our commitment to safety is grounded in our company’s commitment to improving the lives of patients worldwide.
Commitment to Proper Product Labeling, Marketing and Information Practices
The safety of the patients we serve is of paramount importance. Our products are marketed and distributed with thorough labeling and product information. Celgene develops labeling and informational material in compliance with regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Health Canada.
All therapies currently marketed by Celgene are required to include labeling approved by the applicable regulatory bodies. Celgene’s Regulatory Affairs department is charged with enforcing the policies related to the labeling of marketed products. It is Celgene policy to maintain an internal Celgene Product Labeling Portal that provides access to current labeling worldwide as well as access to labeling for products on our external website.
The most critical part of our labeling efforts is conveying how to safely access our therapies, including:
• Approved indication for such therapy
• Therapy description and information
• Therapy clinical pharmacology
• Functions and mechanisms
• Dosage quantity
• Proper administration of therapy
• Warnings and precautions
• Adverse reaction information
• Therapy interactions
• Use in specific patient populations
• Supply of therapy and proper storage
In addition, detailed information is provided regarding the results and evaluations of the therapies during clinical trials and within the product pipeline. This information explains how the clinical trial was organized, the types of dosage and administration used and the results of the trial. This information reflects the most important studies that resulted in approval of the therapy for marketing and distribution for patient use.
Commitment to Drug Safety Surveillance Activities
Since the early days of Celgene, the company has been a leader in effective safety surveillance systems as a component of its broader risk management programs. Every Celgene employee has a role in monitoring and reporting on the safe use of our products. As the company that brought THALOMID® (thalidomide) to the marketplace, we have strived for excellence in patient safety. Safety is deeply engrained in our culture.
Counterfeiting medicines is a serious criminal offense and a major public health risk as counterfeit medicines may include impurities, incorrect quantities of active and inactive ingredients, no active ingredients, or contaminants that can lead to serious health issues. We strongly encourage patients to obtain our treatments through reputable pharmacies and healthcare providers who are licensed to dispense and distribute medicines.
To combat prescription therapy counterfeiting, Celgene takes deliberate, proactive steps to strictly enforce the quality and safety of our treatments. Celgene continues to explore and implement new strategies and technological developments to deter counterfeiting. We also work closely with regulatory bodies, law enforcement agencies, our industry peers, and consumer protection authorities worldwide to ensure safe and appropriate access to our therapies.
Reducing Risk for the Safe Use of Medicinal Products
Celgene is a world leader in pioneering risk minimization techniques to ensure safe use of medicinal products. The Global Risk Management Oversight Committee (GRMOC) is established to ensure that risks related to any of our commercial or development products are identified, assessed and managed effectively.
The GRMOC is responsible for directing our Corporate risk management strategy and approving all Risk Management Plans (RMPs) for both authorized and developmental products. The Committee operates across functions with standing members comprising Celgene’s Chief Medical Officer, and senior leadership for Regulatory Affairs, Drug Safety, Medical Affairs, Legal, and Technical Operations. The Committee is chaired by the Global Drug Safety & Risk Management (GDSRM) Head of Global Risk Management.
Celgene’s GDSRM department is involved in every step of the clinical development process—from inception to marketing—making sure Celgene’s products are safe, and patients are well informed. GDSRM personnel are embedded within clinical development and project teams to ensure continuity of safety assessment at every stage from pre- to post-marketing.
Celgene currently has a unique and comprehensive RMP for each product including a risk mitigation strategy. The overall aim of risk management is to ensure that the benefits of a particular product outweigh the risks by the greatest achievable margin for the patient. This risk management process has three stages that are interrelated. First, the safety profile of the medicinal product is characterized, including what is known and what is not known. Second, pharmacovigilance activities are planned as a key component of effective therapy regulation, clinical practices and public health programs. These activities are used to characterize risks, identify new risks and increase knowledge about the safety profile of therapies. Third, the risk minimization and mitigation planning and implementation occurs and the effectiveness of these activities is assessed.
Teratogenicity, the development of physiological abnormalities or fetal malformation, is a well identified risk for Celgene products REVLIMID®, THALOMID® and POMALYST®. In order to minimize and mitigate this risk global pregnancy prevention programs (PPP) are in place with the overall aim of preventing the risk of embryo-fetal exposure to these products. A secondary goal of the PPP is to inform prescribers, patients and pharmacists about the serious risks and safe-use conditions for utilizing these products. PPP standards to mitigate these risks are implemented in each country where these products are available through clinical studies or commercialization. The program design is adapted to the local regulatory and healthcare system environment. Celgene is one of the leaders in developing effective risk minimization plans such as our PPP. Our programs worldwide have been effective in mitigating the risk of embryo-fetal exposure.
Global Environmental Health and Safety Mission
Celgene is committed to worldwide leadership in our Global Environmental, Health and Safety (EHS) programs in order to effectively minimize occupational and environmental risks. We continue to work towards ensuring the health and safety of all employees so we can maintain this extraordinary level of commitment and continue to attract the best employees at every level of our organization.
Celgene monitors, tracks and routinely reports on the company’s health and safety performance, and continually reviews potential risks and assigns controls to better protect our people. This is particularly important for personnel who are involved in occupational activities where there is a potential risk of exposure. This is true for manufacturing and laboratory staff that handle a myriad of chemicals and biological materials and for support personnel that could be involved with working with potentially harmful materials. For these employees, there is educational, counseling, prevention and risk training, and, if necessary, treatment programs available related to occupational health and safety risk.
Integrate environmental, health and safety objectives and targets into our business strategies and plans.
Comply with environmental, health and safety laws, regulations, standards and ordinances in each of the countries in which we do business.
Educate employees with respect to environmental, health and safety performance and provide training to assist employees in performing their responsibilities.
Strive for an injury-free and environmentally sustainable workplace by building on the belief that incidents, injuries and environmental releases are potentially preventable and by implementing appropriate risk control measures.
Foster environmental, health and safety ethics among management by setting management performance targets into our business strategies.
Act responsibly and communicate openly with our customers, neighbors, employees, government officials and other stakeholders relative to the safety profile of our products and operations.
EHS Areas of Responsibilities:
EHS assists Celgene in managing risk in the following areas:
- Occupational Health
- Product Safety/Stewardship
- Laboratory Services
Through-out the year EHS offers training in a variety of topics. This is not an all-inclusive list as it is ever changing and we tailor our training in order to meet the needs of the company:
- Biohazard and Chemical Waste Removal
- Bloodborne Pathogens
- Chemical and Biologics Manifest Management
- Chemical Hygiene Plan
- Chemical Inventory Management
- Chemical Related Permits
- Chemical Specific
- Classification and Toxicity Designation
- Construction Safety
- Due Diligence
- EHS Procedure Compliance (Air, Water, Waste)
- Electrical Safety/Lock Out Tag Out
- Elevated Work Practices
- Emergency Response
- Employee Exposure / IH Monitoring
- Engineering Controls
- Environmental Risk Assessment (ERA)
- Fire Safety
- Hazard Communication
- Hazard Prevention
- Hazcom Standard Implementation / Globally Harmonized System (GHS)
- Health and Safety Training
- Illness and Injury Prevention Plan
- Indoor Air Quality
- Industrial Hygiene Monitoring
- Injury/Illness/Incident Management
- Job Safety Analyses (JSAs)
- Laboratory/Metrology Collaborations
- Liaison with Medical Services
- Medical Surveillance
- New Employee Training
- Personal Protective Equipment (PPE)
- Potent Compounds
- Process Safety
- Product Safety/Safety Data Sheet (SDS)
- Radiation Safety
- Regulatory Inspections
- Resource Conservation and Recovery Act Hazard Waste
- Safe Handling Storage and Transportation
- Spill Response/Mitigation
EHS Awareness Month
Annually, Celgene conducts Environmental Health & Safety (EHS) Month globally. This effort to foster employee awareness of EHS best practices is typically focused on the theme of risk mitigation. There are many activities programmed into the event and active participation by all employees is encouraged. Typical focus areas are: Potential occupational exposures, motor vehicle safety, slips trips and falls and ergonomics.
Celgene is fortunate to have employees of the highest caliber, whose focus on the single mission of delivering innovative therapies to patients is what makes our company successful. We will continue to work towards ensuring the health and safety of all employees so we can maintain this extraordinary level of commitment and continue to attract the best employees at every level of our organization.