Amgen 2012 Annual Report Download - page 32

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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
evaluation and marketing authorization, various parties, including the national competent authorities, the EMA, the EC and the
marketing authorization holders share pharmacovigilance responsibilities regarding the detection, assessment and prevention of
adverse effects and other medicine-related problems. Healthcare professionals and patients are also encouraged to 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. In 2012, new pharmacovigilance legislation became
effective in the EU that contains new and revised requirements for conducting pharmacovigilance, as well as codifying various
existing requirements previously set out as guidance. The new legislation enhanced the authority of European regulators to require
pharmaceutical companies to conduct post-authorization efficacy and safety studies, both at the time of approval and at any time
afterwards in light of scientific developments. There are also additional requirements to include statements in product labeling
with regard to adverse drug reaction reporting and additional monitoring of products. There also is expected to be significantly
greater transparency of the safety review process as a result of the new legislation.
Other countries such as those in Latin America, Mexico, Brazil, Russia, Turkey 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 (as demonstrated by a certificate
of pharmaceutical product) from a foreign regulatory authority in the United States or EU. The regulatory process in these countries
is less well defined than in the United States and frequently includes manufacturing/testing facility inspections, testing of drug
product on importation and other domestic requirements.
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 whenever 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) 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. 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). On December 19, 2012, Amgen announced that it had finalized a
settlement agreement with the U.S. government, 49 states and the District of Columbia 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 the Inspector General 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. See Note 18, Contingencies and commitments, to the Consolidated Financial
Statements for further information. 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.