AbbVie 2012 Annual Report Download - page 24

alternatives. AbbVie does, however, carry business interruption insurance, which provides a degree of
protection in the case of a failure by a single-source supplier.
Significant safety or efficacy issues could arise for AbbVie’s products, which could have a material adverse
effect on AbbVie’s revenues and financial condition.
Pharmaceutical products receive regulatory approval based on data obtained in controlled clinical
trials of limited duration. Following regulatory approval, these products will be used over longer
periods of time in many patients. Investigators may also conduct additional, and perhaps more
extensive, studies. In addition, due to various product withdrawals and other significant safety issues
related to pharmaceutical products, the amount of time to obtain regulatory approval has increased
industrywide and some health authorities are re-reviewing select products that are already marketed.
If new safety or efficacy issues are reported or if new scientific information becomes available
(including results of post-marketing Phase IV trials), or if there are changes in government standards
regarding safety, efficacy or labeling, AbbVie may be required to amend the conditions of use for a
product. The FDA has authority, based on such new clinical or scientific information, to require
post-marketing studies, clinical trials and labeling changes and compliance with FDA-approved risk
evaluation and mitigation strategies. The FDA’s exercise of this authority could result in delays or
increased costs during product development, clinical trials and regulatory review, increased costs to
comply with additional post-approval regulatory requirements and potential restrictions on marketing of
approved products. Regulatory agencies outside of the United States often have similar authority.
New safety data may emerge from adverse event reports, post-marketing studies, whether
conducted by AbbVie or by others and whether mandated by regulatory agencies or voluntary, and
other sources and may adversely affect sales of AbbVie’s products. For example, AbbVie may
voluntarily provide or be required to provide updated information on a product’s label or narrow its
approved indication, either of which could reduce the product’s market acceptance. If serious safety or
efficacy issues with an AbbVie product arise, sales of the product could be halted by AbbVie or by
regulatory authorities. Safety or efficacy issues affecting suppliers’ or competitors’ products also may
reduce the market acceptance of AbbVie’s products.
New data about AbbVie’s products, or products similar to its products, could negatively impact
demand for AbbVie’s products due to real or perceived safety issues or uncertainty regarding efficacy
and, in some cases, could result in product withdrawal. Furthermore, new data and information,
including information about product misuse, may lead government agencies, professional societies,
practice management groups or organizations involved with various diseases to publish guidelines or
recommendations related to the use of AbbVie’s products or the use of related therapies or place
restrictions on sales. Such guidelines or recommendations may lead to lower sales of AbbVie’s
products.
AbbVie is subject to product liability claims and lawsuits that may adversely affect its business and results of
operations.
In the ordinary course of business, AbbVie is the subject of product liability claims and lawsuits
alleging that AbbVie’s products or the products of other companies that it promotes have resulted or
could result in an unsafe condition for or injury to patients. Product liability claims and lawsuits and
safety alerts or product recalls, regardless of their ultimate outcome, may have a material adverse effect
on AbbVie’s business and reputation and on its ability to attract and retain customers. Consequences
may also include additional costs, a decrease in market share for the products, lower income and
exposure to other claims. Product liability losses are self-insured. Product liability claims could have a
material adverse effect on AbbVie’s business and results of operations.
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