Commitment to Proper Product Labeling, Marketing and Information Practices
Celgene has been a leader in effective safety surveillance systems as a component of its broader risk management programs. 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 US Food and Drug Administration (FDA) and the European Medicines Agency.
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’s 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 effort is conveying how to safely access our therapies, and includes:
- 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
Counterfeiting medicines is a serious criminal offense and a growing public health risk. Counterfeit medicines may be too strong or too weak, missing key ingredients or even made with dangerous contaminants that can lead to serious health issues. When patients consume medicine that is a fake or counterfeit, trust in the quality of medicines is destroyed and hope for successful treatment of their disease is undermined. Celgene believes there is no higher priority than providing patients genuine, safe and effective medicines. It is because of this strong commitment to patient safety that Celgene takes deliberate, sustained and proactive steps to strictly enforce the quality and safety of our treatments.
Our experts continuously implement strategies and explore new technological developments to deter counterfeiting. We also address product integrity issues by putting business practices in place designed to ensure that Celgene therapies are securely distributed within our authorized markets.
Celgene works closely with regulatory bodies, law enforcement agencies, our industry peers and consumer protection authorities worldwide to strengthen, enact and enforce anti-counterfeiting laws as well as raise awareness of counterfeiting. Celgene also supports law enforcement and industry initiatives to combat counterfeiting. In addition, Celgene remains deeply engaged through the Pharmaceutical Security Institute and similar organizations to prevent all types of pharmaceutical crime, including counterfeiting, theft and illegal diversion.
Reducing Risk for the Safe Use of Medicinal Products
Celgene is a world leader in pioneering risk minimization techniques to deliver safe use of medicinal products. The Global Risk Management Oversight Committee (GRMOC) works to minimize 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 commercially authorized and developmental products. The GRMOC operates across functional heads with standing members comprising Celgene’s Chief Medical Officer, Regulatory Affairs, Global Drug Safety and Risk Management, Medical Affairs, Legal, Clinical Research and Development and US Risk Management Strategies. The GRMOC is chaired by the Global Drug Safety & Risk Management (GDSRM) Head of Global Risk Management.
The GDSRM department is involved in every step of the clinical development process—from inception to marketing—making sure Celgene’s therapies are safe and patients are well informed. GDSRM personnel are embedded within clinical development and project teams to increase 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 confirm 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, once the risk minimization and mitigation planning and implementation occurs, the effectiveness of these activities is assessed.
For risk management activities conducted in the US through our Risk Evaluation and Mitigation Strategy (REMS) programs, Celgene introduced a number of innovative features to support prescribers, pharmacies and patients. Upgrades to our internal call center technologies reduced the time taken to complete REMS enrollments and surveys, and the successful launch of a pharmacy web portal has resulted in more than 80 percent of all Celgene pharmacy REMS tasks being fulfilled online. We have an unrelenting passion to provide world-class customer service to those completing Celgene REMS tasks, and we’ve launched additional innovative technologies, such as a REMS mobile application, to achieve this goal.
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 (PPPs) 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 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 RMPs and our programs worldwide have been effective in mitigating the risk of embryo-fetal exposure.