Amgen 2010 Annual Report Download - page 48

publish guidance or rules for biosimilar applicants before approving biosimilar products. The FDA held a public
meeting in November 2010 to seek stakeholder input on the subject and accepted written comments through 2010.
FDA Regulation of Product Marketing and Promotion. The FDA closely reviews and regulates the marketing
and promotion of products. We are required to obtain FDA approval before marketing or promoting a product as a
treatment for a particular indication. Our product promotion for approved product indications must comply with the
statutory standards of the FDCA, and the FDA’s implementing regulations and standards. The FDA’s review of
marketing and promotional activities encompasses, but is not limited to, direct-to-consumer advertising, healthcare
provider-directed advertising and promotion, sales representative communications to healthcare professionals,
promotional programming and promotional activities involving the Internet. The FDA may also review industry-
sponsored scientific and educational activities. The FDA may take enforcement action against a company for
promoting unapproved uses of a product (“off-label promotion”) or for other violations of its advertising and
labeling laws and regulations. Enforcement action may include product seizures, injunctions, civil or criminal
penalties or regulatory letters, which may require corrective advertising or other corrective communications to
healthcare professionals. Failure to comply with the FDA’s regulations also can result in adverse publicity or
increased scrutiny of company activities by the U.S. Congress or other legislators.
FDA Regulation of Manufacturing Standards. The FDA regulates and inspects equipment, facilities, laboratories
and processes used in the manufacturing and testing of products prior to providing approval to market a product. If
after receiving approval from the FDA, we make a material change in manufacturing equipment, location or process,
additional regulatory review may be required. We also must adhere to current Good Manufacturing Practice (“GMP”)
regulations and product-specific regulations enforced by the FDA through its facilities inspection program. The FDA
also conducts regular, periodic visits to re-inspect our equipment, facilities, laboratories and processes following an
initial approval. If, as a result of those inspections, the FDA determines that our equipment, facilities, laboratories or
processes do not comply with applicable FDA regulations and conditions of product approval, the FDA may seek civil,
criminal or administrative sanctions and/or remedies against us, including suspension of our manufacturing oper-
ations. Such issues may also delay the approval of new products undergoing FDA review.
Approval and Post-Approval Regulation Outside the United States. In the EU countries, Switzerland, Canada and
Australia, regulatory requirements and approval processes are similar in principle to those in the United States.
Additionally, depending on the type of drug for which approval is sought, there are currently two potential tracks for
marketing approval in the EU, including a centralized procedure. In the centralized procedure, which is required of all
products derived from biotechnology, a company submits a single marketing authorization application to the EMA
who conducts a thorough evaluation, drawing from its scientific resources across Europe. If the drug product is proven
to fulfill the requirements for quality, safety and efficacy, the CHMP adopts a positive opinion, which is transmitted to
the EC for final approval of the marketing authorization. While the EC generally follows the CHMP’s opinion, it is not
bound to do so. In the EU, biosimilar products have been approved under a sub-pathway of the centralized procedure
since 2006. The pathway allows sponsors of a biosimilar product to seek and obtain regulatory approval based in part
on the clinical trial data of an originator product to which the biosimilar product has been demonstrated to be “similar.”
In many cases, this allows biosimilar products to be brought to market without conducting the full suite of clinical
trials typically required of innovators. After evaluation and marketing authorization, various parties, including the
national competent authorities, the EMA, the EC and the marketing authorization holders share responsibilities for the
detection, assessment and prevention of adverse effects and other medicine-related problems in a process known as
pharmacovigilance. 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.
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
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