Amgen 2009 Annual Report Download - page 54

• an increased rate or number of previously-identified safety-related events
• the discovery of significant problems or safety signals or trends with a similar product that implicates an
entire class of products
• subsequent concerns about the sufficiency of the data or studies underlying the label or changes to the un-
derlying safety/efficacy analysis related to results from clinical trials, including sub-analyses, or meta-
analysis (a meta-analysis is the review of studies using various statistical methods to combine results
from previous separate but related studies) of clinical trials or clinical data performed by us or others
• new legislation or rules by regulatory agencies
For example, on December 16, 2009, based on the TREAT results, we updated the boxed warning in the la-
beling information for ESAs, to reflect an increased risk of stroke when ESAs are administered to CRF patients
to target Hb levels of 13 g/dL and above. (See — “Our ESA products continue to be under review and receive
scrutiny by regulatory authorities.”)
In addition to revised labeling for our products, discovery of new safety information or previously unknown
safety concerns and/or safety signals with our products could also lead to:
• requirement of risk management activities (including a REMS) related to the promotion and sale of our
products
• mandated PMCs or pharmacovigilance programs for our approved products
• product recalls of certain of our approved products
• revocation of approval for our products from the market completely, or within particular therapeutic
areas, and/or
• delay in or fewer treatments being approved by the FDA or other regulatory bodies
Product safety concerns could cause regulatory agencies to impose risk management activities upon us
(including a REMS), which may require substantial costs and resources to negotiate, develop and implement. The
results of these risk management activities could:
• impact the ability of healthcare providers to prescribe, dispense or use our products
• limit patient access to our products
• place administrative burdens on healthcare providers in prescribing our products, or
• affect our ability to compete against products that do not have a REMS or similar risk management activ-
ities
We currently have approved REMS for our ESAs, ENBREL and Nplate®and are currently in discussions
with the FDA regarding an update to the existing REMS for ENBREL and a REMS for our product candidate
ProliaTM.
Further, if new medical data or product quality issues suggest an unacceptable safety risk or previously un-
identified side-effects, we may withdraw some or all affected product — either voluntarily or by regulatory
mandate — in certain therapeutic areas, or completely recall a product presentation from the market for some pe-
riod or permanently. For example, in September 2009, we initiated a voluntary recall of a limited number of
ENBREL SureClick®lots due to a defect in the glass syringe barrel which resulted in a small number of broken
syringes following assembly of the autoinjector device. We may experience the same or other problems in the fu-
ture resulting in broader product recalls or adverse event trends, which may adversely affect the sales of our
products. Additionally, if other parties (including our licensees, such as J&J and Pfizer, or independent inves-
tigators) report or fail to effectively report to regulatory agencies side effects or other safety concerns that occur
from their use of our products in clinical trials or studies or from marketed use, resulting regulatory action could
adversely affect the sales of our products and our business and results of operations.
If regulatory authorities determine that we have not complied with regulations in the R&D of a product can-
didate, a new indication for an existing product or information to support a current indication, they may not
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