Approach to Responsible Marketing
Amgen is committed to providing promotional information to patients and members of the healthcare community regarding Amgen products that is complete, truthful, and non-misleading. All promotional materials are designed to be consistent with the regional or country-specific labeling, fair balanced in their presentation of risks and benefits, describe safety information fully and accurately, and approved by the appropriate Amgen review process prior to use. .
Governance of Promotional Activities
Our aim is to review all promotional material end-to-end to ensure that it meets our standards, which is why we apply a harmonized global review and approval system. Employees use a centralized platform that allows us to consistently streamline the review and approval process, while also providing a better overview of global marketing data. This also helps us identify opportunities for improvement.
Our promotional review process is chaired by promotional experts in our Regulatory Department with leadership overall by the head of Global Promotion, Regulatory Affairs..
Ethical Review and Approval Principles for Promotional Materials
Amgen is committed to ensuring that any promotional information about our products is on-label and contains useful, complete, accessible, accurate, clear, non-ambiguous, legible, fair, and non-misleading content. Additionally, promotional information targeted to appropriate patients includes a balanced presentation of risks and benefits designed to educate and motivate, rather than create fear.
Off-label promotion of our products is strictly prohibited. In the US, when considering information for use in promotion that is not contained in the FDA-approved labeling, Amgen follows the principles outlined in the FDA Guidance for Industry entitled “Medical Product Communications That Are Consistent With the FDA-Required Labeling Questions and Answers” to ensure promotional communications are consistent with product labeling.
Risk assessments are conducted as part of the routine process of our promotional review. We adhere to regulatory authority guidance governing promotional communications where available and evaluations are performed by our regulatory promotion experts as well as legal experts.
Promotional materials are rigorously evaluated during the review process to ensure that content is fully substantiated by supporting evidence. Amgen does not permit inclusion of unsubstantiated product claims regarding either potential benefits or other product attributes nor do we include misleading drug comparisons in our promotional materials.
Transparency is a critical component to truthful and non-misleading communication. We strive to ensure all promotional materials are distinguishable as marketing communications and identifiable as such through clear labeling, avoiding product placements or inappropriate attribution in media and that our efforts are not disguised as market research or non-company created content. Additionally, we are transparent in the communication of the risks associated with our products. We require risk information to be presented prominently and written in clear language appropriate for the intended audience. Material facts about the products we promote are disclosed in our promotional materials, including facts about consequences that may result from use of our medicines. We also routinely test our promotional messages through market research agencies to help ensure our benefit and risk messages are successfully communicated.
Amgen also has long served patients, physicians, and communities by supporting a variety of health education programs singularly or in collaboration with patient advocacy groups or healthcare providers.
As of August 4, 2023