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 (nearly 5,000 pieces globally in 2010, up from slightly more than 4,500 pieces in 2009) 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 Code of Federal Regulations.

The company also uses a centralized process to ensure that marketing materials for distribution in Europe are accurate, appropriate and comply with the European Federation of Pharmaceutical Industries and Associations (EFPIA) Code on the Promotion of Prescription-Only Medicines to, and Interactions with, Healthcare Professionals. The Code defines standards for the ethical promotion of pharmaceutical products to ensure appropriate interactions between pharmaceutical companies and healthcare professionals and patients. 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 adheres to the EUCOMED UNAMEC Code that covers medical devices.

Compliance

If a company is not in compliance with advertising and promotion regulations in the United States, the FDA or the Department of Justice may initiate civil or criminal enforcement actions depending on the seriousness of the violation, its potential impact on public health or other factors. Enforcement actions can range from an untitled letter, the least serious enforcement action, a warning letter, an elevated enforcement action, up to a criminal indictment.

In April 2010, Baxter received a warning letter from the FDA citing select promotional materials created in support of ARALAST NP [Alpha₁-Proteinase Inhibitor (Human)] as misleading. Specifically the FDA identified a promotional brochure that the Agency felt made misleading efficacy claims. Baxter discontinued distribution of the brochure immediately upon receipt of the FDA letter, and began the process of identifying all materials with similar claims while also preparing a response to the FDA. Baxter continues to work with the FDA to ensure the company’s promotional materials meet Agency standards.

Comparable information is not commonly available outside the United States.

See the Priority Update: Ethical Conduct and Legal Compliance for details about Baxter's progress against its goal to continue to champion internal and industrywide ethical sales and marketing practices.

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 works to increase access to healthcare globally through product development, initiatives targeted specifically at the "base of the pyramid"¹, product donations and philanthropic giving. See Access to Healthcare for more detail.