Amgen 2012 Annual Report Download - page 47

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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 or similar products could also lead to:
• requirement of risk management activities (including a REMS) or other FDA compliance actions related to the promotion
and sale of our products;
• mandated PMCs/PMRs or pharmacovigilance programs for our approved products;
• product recalls of our approved products;
• revocation of approval for our products from the market completely, or within particular therapeutic areas;
• increased timelines or delays in being approved by the FDA or other regulatory bodies; and/or
• fewer treatments or product candidates being approved by 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, implement and administer. 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;
• reduce patient willingness to use our products;
• place administrative burdens on healthcare providers in prescribing our products; and/or
• affect our ability to compete against products that do not have a REMS or similar risk management activities.
We currently have approved REMS for our ESAs, Prolia® and Nplate®, and we use third-party service providers to assist in
the administration of our REMS that include elements to assure safe use. For example, our ESA REMS requires applicable
healthcare providers and institutions to enroll in the program, receive education about the product and the REMS and document
and report certain information to us over time. We are responsible for tracking and documenting certain elements of healthcare
provider and institution compliance with the ESA REMS and providing the FDA with periodic assessment reports to demonstrate
that the goals of the REMS are being met. The FDA may modify our REMS based on the results of the periodic assessment reports.
Also, if we or third-party service providers acting on our behalf fail to effectively implement and/or administer the REMS for our
products, we may be required to modify such REMS, and we may be subject to FDA enforcement actions or to civil penalties.
Further, if new medical data or product quality issues suggest an unacceptable or potential safety risk or previously
unidentified 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 period 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. In October 2010, we
initiated a voluntary recall of certain lots of ENBREL due to identification of cracks in a small number of the glass syringes which
may have resulted in product leakage and syringe breakage. Further, beginning in September 2010, we initiated a voluntary recall
of certain lots of EPOGEN® and J&J voluntarily recalled certain lots of PROCRIT®, manufactured by us, because a small number
of vials in each lot were found to contain glass lamellae (extremely thin, barely visible glass flakes) which we believed was a
result of the interaction of the product formulation with glass vials during the shelf life of the product. The recalls were executed
in close cooperation with the FDA. We may experience the same or other problems in the future, resulting in broader product
recalls, adverse event trends, delayed shipments, supply constraints, contract disputes and/or stock-outs of our products, which
may materially and adversely affect the sales of our products, our business and results of operations. Additionally, if we or other
parties (including our independent clinical trial investigators or our licensees, such as J&J, Pfizer, Glaxo and Takeda) 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, including monetary fines and other penalties, could
materially and adversely affect the sales of our products, our business and results of operations.