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.
In 2004, Baxter created a Center of Excellence for Advertising and Promotion to enhance its compliance with promotional regulations companywide. The Center of Excellence is staffed by regulatory professionals who specialize in the review of marketing materials for accuracy and balance in terms of product risks and benefits.
In 2005, Baxter implemented centralized advertising and promotion standards in the United States to replace individual procedures within each business. The new standards incorporate best practices from inside and outside the company. In 2006, Baxter enhanced this procedure. The enhanced procedure provides for a more robust process and documentation surrounding the review, approval and issuance of marketing materials.
Also in 2006, Baxter further expanded these efforts and implemented a centralized process to ensure accuracy and appropriateness of marketing materials for distribution in Europe. It ensures that materials comply with the International Federation of Pharmaceutical Manufacturers Association (IFPMA) Code of Pharmaceutical Marketing Practices, which became effective January 1, 2007. 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.
Compliance
If a company is not in compliance with advertising and promotion regulations, 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 2006, as in 2003 and 2005, Baxter did not receive any untitled letters or warning letters for advertising and promotion issues. In 2004, the company received two warning letters. 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 in developing countries and has numerous programs globally to extend access to its products. See Access to Healthcare for more detail.
