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, miss key ingredients, or even be made with dangerous contaminants that can lead to serious health issues. When patients consume fake medicine, trust in the quality of medicines in general is destroyed and hope for successful treatment of their disease is undermined. Celgene believes there is no higher priority than ensuring that patients receive genuine, safe and effective medicines. It is because of this strong commitment to patient safety that we take deliberate, sustained and proactive steps to strictly enforce the quality and safety of our medicines.
Celgene continuously implements strategies and explores new technological developments to deter counterfeiting. We also address product integrity issues by establishing business practices to ensure that our therapies are securely distributed within our authorized markets. We work closely with regulatory bodies, law enforcement agencies, industry peers and consumer protection authorities worldwide to strengthen, enact and enforce anti-counterfeiting laws and to raise awareness of counterfeiting. We also support law enforcement and industry initiatives to actively combat counterfeiting.
On a global basis, Celgene works with international law enforcement and customer agencies to act against the manufacturers and distributors of counterfeit medicines.
We are also 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 ensure that risks related to any of our commercial or investigational 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 is a cross-functional team that involves Celgene’s Chief Medical Officer, Regulatory Affairs, Global Drug Safety and Risk Management (GDSRM), Medical Affairs, Legal, Compliance, and Clinical Research and Development. The GRMOC is chaired by the GDSRM Head of Global Risk Management.
The GDSRM department is involved in the lifecycle management of products, including every step of the clinical development process—from inception to marketing—making sure the safety profile of our therapies is well-defined and our patients are well- informed. Safety personnel are embedded within clinical development and project teams to help ensure the continuity of safety assessments 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 protect patient safety by confirming that the benefits of a particular product outweigh the risks. This process has three interrelated stages:
1. We characterize the product’s safety profile, including what is known and what is not known.
2. We plan pharmacovigilance activities (defined by the World Health Organization as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem) 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.
3. If required, we plan and implement risk minimization and mitigation measures, and subsequently assess their effectiveness.
We currently conduct risk management activities in more than 80 countries, and the success of these programs means that over 1 million patients have been treated with Celgene IMiDs® compounds, with no in utero exposure resulting in congenital malformations of the type associated with thalidomide. The GDSRM team, working in close collaboration with Celgene colleagues across the globe, is now applying its in-depth risk management knowledge to design similar effective programs for Celgene’s pipeline products.
For risk management activities conducted in the United States, we support prescribers, pharmacies and patients through our Risk Evaluation and Mitigation Strategy (REMS) programs. To avoid embryo- fetal exposure, REMS programs are mandatory for the Celgene products THALOMID® (thalidomide), REVLIMID® and POMALYST®. These programs require prescribers and pharmacists to be certified and patients to enroll and comply with all of the requirements for each program. Our focus on developing innovative features for our REMS programs means that most Celgene prescriber and pharmacy REMS tasks are fulfilled online, saving time and streamlining the REMS process.
We work with other regulatory authorities ex-U.S. on Risk Management Plans to ensure appropriate access to medicines and agreeing on pregnancy prevention programs and educational materials for patients and healthcare providers.
Click here to learn more about REMS and our commitment to the safety of our patients.