Product Use

Advertising and Promotion

The U.S. Food and Drug Administration (FDA) and other governmental 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, convention booths, and other promotional materials and activities.

Baxter's Advertising and Promotion staff manage the company's compliance with promotional regulations companywide, reviewing marketing materials for accuracy and balance in terms of presentation of product risks and benefits. The company’s approach takes into account regulations and standards which vary by region:

  • United States - Baxter’s advertising and promotion standards for all business groups incorporate best industry practices and are reviewed rigorously for compliance with the U.S. Code of Federal Regulations.
  • Canada - Baxter’s advertising and promotion standards incorporate industry best practices as per Pharmaceutical Advertising Advisory Board (PAAB) guidelines and are reviewed for compliance to Health Canada regulations.
  • Latin America - Baxter applies advertising and promotion standard review procedures to ensure compliance with local and regional marketing promotion codes and regulations.
  • Europe - Baxter ensures that marketing materials for distribution in the region comply with applicable laws and regulations as well as with the European Federation of Pharmaceutical Industries and Associations (EFPIA) Code of Practice on the promotion of prescription-only medicines to, and interactions with, healthcare professionals. The company’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 adheres to the EUCOMED UNAMEC Code that covers medical devices.
  • Asia Pacific - Baxter uses an electronic approval system that enables the company to comply with advertising and promotion codes, regulations and internal standards in 15 countries.

Compliance

If a company fails to comply with advertising and promotion regulations in the United States, the FDA or the Department of Justice may initiate civil or criminal enforcement actions. Enforcement actions can range from an untitled letter (the least serious) or a warning letter (an elevated action) up to a criminal indictment. In 2012 and 2011, no enforcement actions were initiated against Baxter by the FDA.

2008 2009 2010 2011 2012
Untitled Letters 1 0 0 0 0
Warning Letters 0 1 1 0 0

Comparable information is not commonly available outside the United States.

See Priorities and Goals for information about Baxter's progress against its goal to continue to champion internal and industrywide ethical sales and marketing practices.

See Access to Healthcare for information about Baxter’s approach to increasing access to healthcare globally.