Amgen 2009 Annual Report Download - page 40

Each REMS is unique and varies depending on the specific factors required. Failure to comply with a
REMS, including the submission of a required assessment or any modification to a REMS, may result in sub-
stantial civil or criminal penalties. We currently have approved REMS for our ESAs, ENBREL and Nplate®.
Additionally, in response to the FDA’s request, under authority prescribed by the FDAAA, we are currently in
discussions with the FDA regarding an update to the existing REMS for ENBREL and a REMS for our product
candidate ProliaTM.
Adverse events that are reported after marketing approval also can result in additional limitations being
placed on a product’s use and, potentially, withdrawal of the product from the market. The FDA has authority to
mandate labeling changes to products at any point in a product’s lifecycle based on new safety information or as
part of an evolving label change to a particular class of products. Also under the FDA’s PLR implemented in
2006, we are required to make changes to the existing format of U.S. product package inserts for human pre-
scription drug and biological products with the intent of making product information more easily accessible. The
PLR requires revised standards of content and format of labeling and provides timelines for when new and pre-
viously approved products must comply with the new regulations. During the PLR conversion process from an
old format to the new PLR format, the FDA has the authority to evaluate the package insert information to ensure
that it accurately reflects current knowledge and may revise, add or remove information in the old format that
could substantively impact the content of the product package insert for the new format. Failure to implement
FDA-mandated changes may result in civil or criminal penalties. (See “Item 1A. Risk Factors — Our ESA prod-
ucts continue to be under review and receive scrutiny by regulatory authorities.” and “— Our current products
and products in development cannot be sold if we do not gain or maintain regulatory approval.”)
The FDA also uses various advisory committees of external experts to assist in its mission to protect and
promote the public health, to obtain independent expert advice on scientific, technical and policy matters. The
committees are generally advisory only and FDA officials are not bound to or limited by their recommendations.
We have participated in meetings of the ODAC, the CRDAC and the ACRHD, among others, to address certain
issues related to Aranesp®, EPOGEN®and ProliaTM, respectively. The FDA has also announced that it will call
an advisory committee meeting in 2010 to re-evaluate the use of ESAs to treat anemia in patients with CKD and
the advisory committee could consider lowering targeted Hb levels and reducing approved dosing for ESAs.
FDA Regulation of Product Marketing and Promotion. The FDA closely reviews and regulates the market-
ing and promotion of products. We are required to gain 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 advertis-
ing, 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 adver-
tising 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 communica-
tions to healthcare professionals. Failure to comply with the FDA 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, labo-
ratories and processes used in the manufacturing and testing of products prior to providing approval to market a
product. If after receiving clearance 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 Manu-
facturing 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, facili-
ties, laboratories and processes following an initial approval. If, as a result of these inspections, the FDA
determines that our equipment, facilities, laboratories or processes do not comply with applicable FDA regu-
lations and conditions of product approval, the FDA may seek civil, criminal or administrative sanctions and/or
remedies against us, including the suspension of our manufacturing operations.
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