Product Use
Advertising and Promotion
The U.S. Food and Drug Administration (FDA) and other agencies worldwide regulate the advertising and promotion of pharmaceuticals, medical devices and biologics. Included in FDA's oversight are print and broadcast advertising, websites, press releases, sales brochures, scientific symposia and convention booths, among other promotional materials and activities.
Baxter’s Advertising and Promotion staff manage the company’s compliance with promotional regulations companywide. These regulatory professionals review marketing materials (more than 5,300 pieces globally in 2008) for accuracy and balance in terms of product risks and benefits. Baxter‘s advertising and promotion standards for all business groups in the United States incorporate best practices from inside and outside the company and comply with the AdvaMed Code of Ethics on Interactions with Healthcare Professionals.
The company also uses a centralized process to ensure that marketing materials for distribution in Europe are accurate, appropriate and comply with the International Federation of Pharmaceutical Manufacturers Association (IFPMA) Code of Pharmaceutical Marketing Practices. The Code defines standards for the ethical promotion of pharmaceutical products to ensure appropriate interactions between IFPMA member companies and healthcare professionals.
Member companies must comply with applicable national codes or the IFPMA code if no national code exists. Baxter's procedures ensure review of marketing materials at the pan-European level, as well as at the country level for compliance with local codes of practice and national product licenses.
Baxter also has a global review committee that reviews materials and activities such as international medical congresses and global collateral materials for compliance regardless of location. These are then reviewed at the local level as well.
Compliance
If a company is not in compliance with advertising and promotion regulations in the United States, the FDA may initiate enforcement actions depending on the seriousness of the violation, its potential impact on public health or other factors. Enforcement actions are most often in the form of an untitled letter, the least serious enforcement action, or a warning letter, an elevated enforcement action.
In 2008, Baxter received an untitled letter from the FDA related to a promotional email describing FEIBA (the company’s Anti-Inhibitor Coagulant Complex for treatment of hemophilia) that the FDA felt minimized the risks and overstated the product's efficacy. Baxter cooperated with the FDA to understand and address the Agency's concerns and ensure that future promotional materials comply with applicable standards.
| U.S. FDA Letters Related to Advertising/Promotion Received by Baxter, 2004-2008 | |||||
| 2004 | 2005 | 2006 | 2007 | 2008 | |
| Untitled Letters | 0 | 0 | 0 | 0 | 1 |
| Warning Letters | 2 | 0 | 0 | 0 | 0 |
Comparable information is not commonly available outside the United States.
Access to Healthcare
Worldwide, many people lack access to Baxter's products due to insufficient resources, inadequate healthcare infrastructure, disruption caused by natural disasters and other crises, and other factors. Baxter offers products that expand access to healthcare in developing countries and undertakes other initiatives to extend access to its products. See Access to Healthcare for more detail.
