Advertising and Promotion
Medtronic is committed to promoting our therapies responsibly and complies with both government regulations and voluntary codes created by medical technology industry associations.
Legal and Regulatory Review
Medtronic product advertising in the United States is regulated by the Food and Drug Administration (FDA and various federal and state consumer protection laws and by other agencies worldwide.
To ensure adherence to FDA law and policy, each Medtronic business has several levels of legal and regulatory review for promotional and marketing materials used both inside and outside of the United States. These processes help ensure accuracy, balance in terms of risks and benefits, and promotion consistent with the approved product’s labeling. Print and broadcast advertising, web sites, press releases, sales brochures, and materials for Medtronic-sponsored medical education go through business level reviews.
Direct to Consumer Advertising
During Medtronic’s fiscal year 2009, medical technology industry association AdvaMed released guiding principles for marketing medical devices in response to concerns raised by consumer groups. Medtronic played an integral role in developing the AdvaMed principles, which include guidelines on direct-to-consumer advertising, and supports them entirely. In addition, Medtronic has its own internal Direct to Consumer Guidelines.
(Note: When Medtronic uses the expression “direct-to-consumer,” we mean directly to patients or individuals, as opposed to physicians who are generally our customers.)
Medtronic Corporate and Business Policies on Unapproved Uses
Medtronic has both corporate and business level policies on the prohibition of promoting approved products for unapproved uses in the United States and related issues, including appropriate parameters for activities involving Office of Medical Affairs, Medtronic-sponsored education, and sponsorship of continuing medical education. These policies are reinforced by corporate and business level training. An internal Medtronic working group, with business unit interdisciplinary representation, meets regularly to reinforce best practices across the organization.