The preparation, use, and dissemination of timely, accurate, and balanced promotional information about Amgen’s products and areas of therapeutic interest to Amgen, are essential to Amgen’s mission to serve patients. Promotion of biotech and pharmaceutical products approved by regulatory bodies is regulated in every country in which Amgen operates. In the U.S., promotion is regulated by the Food and Drug Administration (FDA). Promotion regulations are designed to safeguard public health by ensuring that healthcare professionals and consumers are provided with information regarding Amgen products’ uses, risks, and benefits that is truthful, adequate, balanced, and based on valid scientific evidence and sound clinical medicine. No public communication may be made with the intent of promoting Amgen products as safe and effective for any use before regulatory approval of the product for such uses is obtained.
Promotional Activities
When Amgen staff or their representatives promote Amgen products, all promotional discussions and promotional information prepared, used, or distributed must be complete, accurate and not misleading. Amgen staff or their representatives are required to review the additional Amgen governance documents that address promotional activities and approval of promotional materials.
- On-label: Claims relating to the use, effectiveness, or safety of Amgen’s products must be consistent with country-specific approved labeling and prescribing information.
- Off-label promotion is strictly prohibited, and no communication may be made with the intent of promoting Amgen products as safe or effective for any use before FDA or other regulatory approval for such use is obtained.
- The word “safe” must never be used to describe a medicinal product without proper qualification.
- Fair balance: When discussing Amgen products, Amgen staff or their representatives must always ensure their presentations provide “fair balance.” All safety information should be described fully and accurately; it should not be characterized as a positive product attribute, or minimized in any way. Full prescribing information must be provided in connection with every promotion or discussion concerning Amgen products.
- Promotional materials: Only material that is approved by Amgen for promotional use may be used in connection with discussions about Amgen products. Amgen staff or their representatives are prohibited from creating or distributing “home-made” materials and from altering Amgen-approved promotional materials in any way.
- Statements concerning competitors’ products: Amgen staff or their representatives may make direct comparisons between an Amgen product and a competitor’s product regarding product efficacy, safety or other characteristic only if such a claim is approved by Amgen and supported by substantial evidence (e.g., head-to-head clinical trials).
- Direct-to-consumer communications are subject to additional restrictions and must comply with applicable local laws and regulations.
Product Reimbursement Information
In the U.S., Amgen staff and their representatives must keep the following in mind when providing information about product reimbursement.
- Reimbursement information provided to patients, healthcare providers, payers and others must be accurate and not misleading.
- Reimbursement information or support provided to healthcare providers must not involve the unlawful promotion of unapproved uses of Amgen’s products.
- All reimbursement assistance program materials provided to patients, physicians or others must be reviewed and approved by Amgen.
