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Limits on Gifts and Other Items Provided to Medical or Health Professionals

As part of Amgen’s Corporate Compliance Program, Amgen has established limits on gifts, meals and other items provided to medical or health professionals.  The California Health and Safety Code requirements relating to drug marketing practices not only require that such limits be included in a pharmaceutical company’s corporate compliance program, but also require that such companies establish “a specific annual dollar limit on gifts, promotional materials, or items or activities that the pharmaceutical company may give or otherwise provide to an individual medical or healthcare professional” in accordance with the OIG Guidance and the PhRMA Code.

The following are the specific limits that Amgen has adopted. It is important to note that these are maximum amounts. For example, in the meals category, the maximum amount would be reached for a medical or health professional only in the unlikely event that such person received the maximum number of meals permitted by several sales teams and functional areas, and the cost of each such meal was the maximum permitted by the Amgen standards

Category Annual Limit per Medical or Health Professional
Meals1 The total annual limit is $2,000, which represents specific limits on the number of dinners (further limited to $125 each) and other meals (further limited to $50 each) that may be provided to a medical or health professional. All such meals must be provided in compliance with Amgen’s compliance standards, which include per meal limits and other requirements intended to ensure compliance with the PhRMA Code.
Attendance at Promotional Speaker Programs Meals provided to attendees at Amgen-sponsored promotional speaker programs are included in the annual limit for meals, set forth above.
Receptions at Professional Association Meetings or Continuing Education Programs When Amgen sponsors a reception in conjunction with a professional association meeting or continuing education event, the Amgen compliance standards require that the reception must be open to all attendees at the professional meeting or continuing education event. Amgen does not (and indeed generally cannot) identify all attendees, and therefore meals or refreshments provided at such receptions are not counted toward the annual spending limit. However, although meals and refreshment provided at receptions do not count toward the annual dollar limit, they are subject to Amgen’s compliance standards, which, among other safeguards, limit the cost per invitee or estimated attendee to $150.
Gifts The total annual limit per healthcare professional is $150. All gifts must be in compliance with the Amgen compliance standards, which require that gifts must provide patient benefit or be related to a healthcare professional’s practice, must have a retail value of no more than $100, and must meet other requirements intended to ensure compliance with the PhRMA Code.
“Reminder” Items Amgen distributes practice-related “reminder” items bearing Amgen’s name, such as pens, notepads and reprints of articles relating to studies involving Amgen products or disease states of interest to Amgen, which have minimal value (i.e., value of less than $10). Amgen does not track the distribution of such items or include them in the annual gift limit. However, such items are provided in accordance with the requirements of the PhRMA Code, which requires that such items be related to a health professional’s practice as opposed to being provided for personal benefit.

1. As contemplated by the California Health and Safety Code, the annual spending limits do not include meals provided as part of a medical or health professional’s paid consulting arrangement with Amgen (e.g., meals provided during a meeting of physician consultants to Amgen, or meals provided to a speaker retained by Amgen in conjunction with performance of the speaking engagement).  The Amgen compliance standards require that payment pursuant to such arrangements must not exceed fair market value, and that meals provided to consultants must be modest and subordinate to the business activity being conducted for Amgen, in conformance with the OIG Guidance and PhRMA Code.

 

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