Promotion of pharmaceutical products is regulated in every country in which Amgen operates. In the U.S., promotion is regulated by the Food and Drug Administration (FDA). Promotional regulations are designed to safeguard public health by ensuring that health care professionals and consumers are provided with information that is truthful regarding the product’s uses, risks, and benefits and the information is adequate, balanced, and based on valid scientific evidence and sound clinical medicine.
In the U.S., promotion and claims made about pharmaceutical products should be consistent with FDA-approved product labeling. No public communication should be made with the intent of promoting pharmaceutical products as safe and effective for any use before FDA approval of the product for such uses is obtained. However, the FDA does not intend to restrict the full exchange of scientific information, so it distinguishes between a company’s promotional activities (which should focus on approved uses) and company-sup-ported scientific and educational activities, which are independent of promotional influence.
In order to ensure compliance with FDA regulations in this area, all promotional materials for Amgen’s products must be reviewed and approved by representatives of the Marketing, Medical Affairs, Clinical/Medical, Law, and Regulatory Departments prior to distribution. Furthermore, departmental guidelines exist to ensure that scientific and educational activities sponsored by Amgen are independent and non-promotional.
Similar controls are in effect in other countries in which Amgen markets its products. Individuals are instructed to refer to the policies in effect at their location and to request guidance from their supervisor, the compliance representative with responsibility for their geographic area, the EU Director of Compliance, or the Chief Compliance Officer as appropriate.
Please refer to Amgen’s current Promotional Materials Policy for additional details regarding the policy and the obligations of individuals subject to the policy.
