AbbVie 2014 Annual Report Download - page 23

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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 product in question, 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.
AbbVie is subject to cost-containment efforts and pricing pressures that could cause a reduction in
future revenues and operating earnings, and changes in the terms of rebate and chargeback programs,
which are common in the pharmaceuticals industry, could have a material adverse effect on AbbVie’s
operations.
Cost-containment efforts by governments and private organizations are described in greater detail in
Item 1, ‘‘Business—Regulation—Commercialization, Distribution, and Manufacturing.’’ To the extent these
cost containment efforts are not offset by greater demand, increased patient access to health care, or other
factors, AbbVie’s future revenues and operating earnings will be reduced. In the United States, the
European Union and other countries, AbbVie’s business has experienced downward pressure on product
pricing, and this pressure could increase in the future.
In the United States, practices of managed care groups and institutional and governmental purchasers
and United States federal laws and regulations related to Medicare and Medicaid, including the Medicare
Prescription Drug Improvement and Modernization Act of 2003 and the Patient Protection and Affordable
Care Act, contribute to pricing pressures. Recently enacted changes to the health care system in the United
States and the increased purchasing power of entities that negotiate on behalf of Medicare, Medicaid, and
private sector beneficiaries could result in additional pricing pressures.
In numerous major markets worldwide, the government plays a significant role in funding health care
services and determining the pricing and reimbursement of pharmaceutical products. Consequently, in those
markets, AbbVie is subject to government decision-making and budgetary actions with respect to its
products. In particular, many European countries have ongoing government-mandated price reductions for
many pharmaceutical products, and AbbVie anticipates continuing pricing pressures in Europe. Differences
between countries in pricing regulations could lead to third-party cross-border trading in AbbVie’s products
that results in a reduction in future revenues and operating earnings.
Rebates related to government programs, such as fee-for-service Medicaid or Medicaid managed care
programs, arise from laws and regulations. AbbVie cannot predict if additional government initiatives to
contain health care costs or other factors could lead to new or modified regulatory requirements that
include higher or incremental rebates or discounts. Other rebate and discount programs arise from
contractual agreements with private payers. Various factors, including market factors and the ability of
2014 Form 10-K 17