Amgen 2013 Annual Report Download - page 17

In the EU, biosimilars have been approved under a specialized pathway of the centralized procedure. The pathway allows sponsors of a biosimilar to
seek and obtain regulatory approval based in part on the clinical trial data of an originator product to which the biosimilar has been demonstrated to be
“similar.” In many cases, this allows biosimilars to be brought to market without conducting the full suite of clinical trials typically required of originators.
After marketing authorization is obtained, we and various other parties share pharmacovigilance responsibilities regarding the detection, assessment and
prevention of adverse effects and other medicine-related problems. Regulatory authorities can demand that safety data or warnings be included on product
labels and be provided to healthcare professionals, or recommend the temporary suspension or complete withdrawal of a product from the market.
Other countries such as Russia, Turkey and those in Latin America and the Middle East have a less comprehensive review process in terms of data
requirements and for the most part rely on prior marketing approval from a foreign regulatory authority in the United States or EU. The regulatory process in
these countries is often less well defined than in the United States and frequently includes manufacturing/testing facility inspections, testing of drug product
upon importation and other domestic requirements.
Other Regulation
We are also subject to various 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. False claims laws prohibit knowingly and willingly presenting, or causing to
be presented for payment to third-party payers (including Medicare and Medicaid) any 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. 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).
On December 19, 2012, Amgen announced that it had finalized a settlement agreement with the U.S. government and various other parties regarding
allegations that Amgen's promotional, contracting, sales and marketing activities and arrangements caused the submission of various false claims under the
Federal Civil False Claims Act and various State False Claims Acts. In connection with entering into the settlement agreement, Amgen also entered into a
corporate integrity agreement with the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services that requires Amgen to maintain
its corporate compliance program and to undertake a set of defined corporate integrity obligations for a period of five years. 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 in the future our
practices might be further challenged under anti-kickback or similar laws.
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 business has been and will continue to be subject to various other U.S. and foreign laws, rules and/or regulations.
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