Amgen 2011 Annual Report Download - page 46

report adverse effects and other medicine-related problems. This process includes the collection of adverse drug
reaction reports as part of the follow-up on any side effects of a product, and upon assessment, the authorities can
decide to demand that product labels be updated with safety data or warnings, that safety data or warnings be
provided to healthcare professionals, or recommend the temporary suspension or complete withdrawal of a
product from the market.
Other. We are also subject to various federal and state laws, as well as foreign laws, pertaining to healthcare
“fraud and abuse,” including anti-kickback laws and false claims laws. Anti-kickback laws make it illegal to
solicit, offer, receive or pay any remuneration in exchange for, or to induce, the referral of business, including the
purchase or prescription of a particular drug that is reimbursed by a state or federal program. The federal
government and the states have published regulations that identify “safe harbors” or exemptions for certain
arrangements that do not violate the anti-kickback statute. We seek to comply with the safe harbors wherever
possible. Due to the breadth of the statutory provisions and the absence of guidance in the form of regulations or
court decisions addressing some of our practices, it is possible that our practices might be challenged under anti-
kickback or similar laws. False claims laws prohibit knowingly and willingly presenting, or causing to be
presented for payment to third-party payers (including Medicare and Medicaid), claims for reimbursed drugs or
services that are false or fraudulent, claims for items or services not provided as claimed or claims for medically
unnecessary items or services. Our activities related to the sale and marketing of our products may be subject to
scrutiny under these laws. Violations of fraud and abuse laws may be punishable by criminal and/or civil
sanctions, including fines and civil monetary penalties, as well as the possibility of exclusion from federal
healthcare programs (including Medicare and Medicaid). If the government were to allege against or convict us
of violating those laws or if we entered into a settlement with the government, there could be a material adverse
effect on our business, including our stock price. Our activities could be subject to challenge for the reasons
discussed above and due to the broad scope of those laws and the increasing attention being given to them by law
enforcement authorities.
We are also subject to regulation under the Occupational Safety and Health Act, the Toxic Substances
Control Act, the Resource Conservation and Recovery Act and other current and potential future federal, state or
local laws, rules and/or regulations. Our R&D activities involve the controlled use of hazardous materials,
chemicals, biological materials and various radioactive compounds. We believe our procedures comply with the
standards prescribed by federal, state or local laws, rules and/or regulations; however, the risk of injury or
accidental contamination cannot be completely eliminated. While we are not required to do so, we strive to
conduct our research and manufacturing activities in a manner that meets the intents and purposes of the National
Institutes of Health Guidelines for Recombinant DNA Research.
Additionally, the U.S. Foreign Corrupt Practices Act (FCPA) prohibits U.S. corporations and their
representatives from offering, promising, authorizing or making payments to any foreign government official,
government staff member, political party or political candidate in an attempt to obtain or retain business abroad.
The scope of the FCPA includes interactions with certain healthcare professionals in many countries. Other
countries have enacted similar anti-corruption laws and/or regulations.
Our present and future business has been and will continue to be subject to various other U.S. and foreign
laws, rules and/or regulations.
Research and Development and Selected Product Candidates
Our vision is to deliver therapeutics that can make a meaningful difference in patients’ lives. Therefore, we
focus our R&D on novel human therapeutics for the treatment of grievous illness in the areas of oncology,
hematology, inflammation, bone health, nephrology, cardiovascular and general medicine, which includes
neuroscience. We take a modality-independent approach to R&D — that is, we identify targets, and then choose
the modality best suited to address a specific target. As such, our discovery research programs may yield targets
that lead to the development of human therapeutics delivered as large molecules (such as proteins, antibodies and
peptibodies) or small molecules.
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