Responsible Sales & Marketing Practices

To address increased public concern about the interaction between sales and marketing personnel and members of the medical community, we continually work to ensure that our employees meet the highest ethical and professional standards through our Ethics and Compliance program.

Abbott sales representatives are the most visible interface between our company and physicians and other health professionals. Our employees play an important role in providing doctors with information about disease-specific data, new treatment approaches, patient initiatives, and in some cases, clinical trial results – all of which can significantly affect a patient's health. To address increased public concern about the interaction between sales and marketing personnel of health care companies and members of the medical community, we continually work to ensure that our employees meet the highest ethical and professional standards, and that they recognize and avoid situations that may present a conflict of interest. It is our goal to build trust with our customers through our daily engagement activities.

We provide all commercial sales and marketing employees with clear direction and policies on how we will market, promote and sell our products around the world. In the United States, these employees follow a set of Operating Procedures for Program Funding that incorporates both the Pharmaceutical Research and Manufacturers of America and AdvaMed codes of conduct – industry standards for the pharmaceutical and medical device industries, respectively. Outside of the United States, our employees comply with local policies that are aligned with applicable laws or industry codes. We also require all marketing and sales personnel to complete additional training related to the marketing, promoting and selling of our products. Abbott also supports the principles of the International Code of Marketing Breast Milk Substitutes.

The OEC is available to provide guidance and make recommendations to employees on an ongoing basis.

We also require our employees to abide by the high standards outlined in the Abbott Code of Business Conduct. The OEC conducts a prompt and thorough investigation into any allegations of inappropriate activity or behavior. We have a zero tolerance policy for behaviors that breach the code. Disciplinary action is taken, which can include termination, if violations are found.

IFPMA Global Marketing Code

The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), a global nonprofit, nongovernmental organization that represents industry associations and research-based pharmaceutical and vaccine companies, updated its Code of Pharmaceutical Marketing Practice in 2006. The code sets standards for the promotion of pharmaceutical products to health care professionals, as well as member companies' interactions with these individuals. Specifically, it introduces stricter and clearer guidelines for the pharmaceutical industry regarding organization of international events, company sponsorship, hospitality and entertainment, acceptable gifts and new procedures to ensure compliance. It also calls for the establishment of a network of compliance officers from more than 50 global companies, including those from Abbott, to share and exchange best practices with regard to ethical promotional practices on a regular basis.

The updated code took effect on January 1, 2007. Abbott, along with others in our industry, helped launch the code by sharing best practices on implementing the standards.

IFPMA Code

Responsible Advertising to Consumers

We subscribe to voluntary industry guidelines on sales and marketing practices, including direct-to-consumer (DTC) advertising. DTC advertising can help raise consumer awareness about health and disease, and medicines and treatment options. As a member of Pharmaceutical Research and Manufacturers of America (PhRMA), we worked with others in our industry to develop voluntary principles to ensure that DTC advertising is done responsibly. Guiding Principles on Direct to Consumer Advertisements About Prescription Medicines, launched in 2006, go beyond FDA regulations, including educating physicians prior to any new DTC advertising campaign and promoting health and disease awareness as part of DTC advertising. Abbott complies with these principles.

PhRMA also created the Office of Accountability to receive public comments regarding DTC advertising. In 2008, the group released a report analyzing recent comments, primarily from patients and consumers. Most comments addressed the public health benefits of DTC advertising, such as promoting awareness. Many patients responded positively to educational elements. Negative comments tended to focus on details of individual ads.

These include the recently updated PhRMA Code on Interactions with Health Care Professionals, which took effect in January 2009, and the new AdvaMed Code of Ethics on Interactions with Healthcare Professionals.

The Office of Accountability Report

In a related effort to receive feedback on pharmaceutical advertising, PhRMA assembled a panel of independent health professionals to view television and print ads when the guidelines went into effect. The panel's recommendations are outlined in a new report, "DTC Advertising Trends and PhRMA's ‘Guiding Principles.'"

DTC Panel Report

Infant Nutrition

Abbott is a leading manufacturer of infant formulas. We agree with medical and health organizations throughout the world that breastfeeding is the best form of infant nutrition and should be the first choice for babies. When an alternative to breastfeeding is necessary or chosen, we offer high-quality infant formulas and nutrition products. We comply with all relevant laws, regulations and promotional standards around the world. This includes adhering to principles of the World Health Organization's (WHO) International Code of Marketing of Breast Milk Substitutes where it has been implemented by governments. These principles cover appropriate labeling and promotion of breast milk substitutes. We conduct audits of our marketing and sales practices in each market where our infant formula is sold to ensure compliance with these provisions. Three countries have not implemented the WHO code – the United States, Canada and Japan. Local standards in these countries are robust and broadly align with the WHO code.

Better Product Labeling

Each year, more than 50 million errors occur during the filling of some 3 billion prescriptions in the United States alone, many of them as a result of misread labels.* Building on our commitment to patient safety, we reviewed and redesigned product labels for all of our pharmaceutical products to make it easier for pharmacists to dispense our medicines properly.

As part of the process, we studied literature on dispensing errors and human factors, observed dispensing in pharmacies, and interviewed and sought feedback from pharmacists, physicians and patients. Our findings led to a new standardization process that highlights critical product identification information such as brand name, generic name, dosage strength, quantity and dosage form on the front panel of a label. Additionally, the size of the label text corresponds with the importance of the information it represents. Color also is used to highlight critical information about product strength and special warnings. In certain cases, product images may be included to provide a safety check that the correct product has been selected.

Beginning in 2006, all new Abbott products filed for approval with regulatory agencies included the new label format. We continue our efforts to convert labels, both domestically and internationally, to the new standard format in accordance with all local regulatory requirements.

*Flynn, Elizabeth A., Kenneth N. Barker, Brian J. Carnahan. National observational study of prescription dispensing accuracy and safety in 50 pharmacies. Journal of the American Pharmaceutical Association; 43(2):191–200.

Addressing Concerns

Abbott responds proactively whenever there are safety concerns involving one of our products and a recall becomes necessary. Recalls typically result from noncompliance with packaging or labeling specifications; very rarely do they stem from product quality or safety concerns. Nevertheless, we view even one such incident as one too many.

We thoroughly investigate each instance and communicate findings and lessons learned to the appropriate regulators, to others in our industry, if appropriate, and across all our business divisions.