Amgen 2007 Annual Report Download - page 44

humans; if we fail to adequately manage these trials we may not be able to sell future products and our sales
could be adversely affected.”)
Applications. The results of preclinical and clinical trials are submitted to the FDA in the form of a BLA for
biologic products subject to the Public Health Service Act or a New Drug Application (“NDA”) for drugs subject
to the approval provisions of the Federal Food, Drug and Cosmetic Act. The submission of the application is no
guarantee that the FDA will find it complete and accept it for filing. If an application is accepted for filing, and
following the FDA review, the FDA may grant marketing approval, request additional information, or deny the
application if it determines that the application does not provide an adequate basis for approval. As a condition of
approval, the FDA may require postmarketing clinical trials to confirm the product’s safety and efficacy for its
intended use. We cannot take any action to market any new drug or biologic product in the United States until
our appropriate marketing application has been approved by the FDA.
Post-approval Phase. On September 27, 2007, President Bush signed into law the Food and Drug Admin-
istration Amendments Act of 2007 (the “FDAAA”), which significantly added to the FDA’s authority. Under the
FDAAA, if the FDA becomes aware of new safety information after approval of a product, they may require us
to conduct further clinical trials to assess a known serious risk, signals of serious risk or to identify an unexpected
serious risk. If required to conduct a post-approval study, periodic status reports must be submitted to the FDA.
Failure to conduct such post-approval studies in a timely manner may result in substantial civil fines.
The FDAAA also gave the FDA authority to require us or other companies to implement a Risk Evaluation
and Mitigation Strategy (“REMS”) for a product when necessary to minimize known and preventable safety risks
associated with the product. The FDA may require the submission of a REMS before a product is approved, or
after approval based on “new safety information,” including new analyses of existing safety information. A
REMS may include a medication guide, patient package insert, a plan for communication with healthcare pro-
viders, or other elements as the FDA deems are necessary to assure safe use of the product, which could include
imposing certain restrictions on distribution or use of a product. A REMS must include a timetable for sub-
mission of assessments of the strategy at specified time intervals. Failure to comply with a REMS — including
the submission of a required assessment — may result in substantial civil or criminal penalties.
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. (See
“Item 1A. Risk Factors — Recent labeling updates to our ESAs and potential future labeling changes or recom-
mendations from the upcoming March 13, 2008 ODAC meeting may adversely impact the use, sales and
reimbursement of our ESAs.”) Failure to implement FDA-mandated changes may result in civil or criminal
penalties. (See “Item 1A. Risk Factors — Our current products and products in development cannot be sold if we
do not gain or maintain regulatory approval of our products and we may be required to perform additional clin-
ical trials or change the labeling of our products or take other potentially limiting or costly actions if we or
others identify side effects after our products are on the market.”)
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 the FDA approval before marketing or promoting a
product as a treatment for a particular indication. Our product advertising and promotion for approved product
indications must comply with the statutory standards of the Federal Food, Drug and Cosmetic Act, and the
FDA’s implementing regulations and standards. The FDA’s review of marketing and promotional activities en-
compasses, but is not limited to, direct-to-consumer advertising, sales representative communications to
healthcare professionals, promotional programming, and promotional activities involving the Internet. The FDA
also reviews 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, 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 increase scrutiny of company activities by Congress or other legislators.
32