Amgen 2009 Annual Report Download - page 39

to the approval provisions of the FDCA. 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, following the FDA’s 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. 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. After we have obtained approval to market our products, we monitor adverse events
from the use of our products and report these events to regulatory agencies, along with information from post
marketing surveillance or studies. We may utilize other research approaches to learn or confirm information
about our marketed products, including observational studies and patient registries, and may engage in risk man-
agement activities such as physician education initiatives and patient advocacy group initiatives. We may also
conduct, or be required by regulatory agencies to conduct, further clinical trials to provide additional information
on our marketed products’ safety and efficacy. These additional trials may include, among other things, studying
different doses or schedules of administration that were used in previous studies, use in other patient populations
or other stages of the disease or use over a longer period of time. Additional trials of this nature are sometimes
required by regulatory agencies as a condition of their approval to market our products and they may also request
or require that we conduct specific studies, including observational epidemiological studies, in order to identify
or assess possible safety risks of our marketed products that are observed or suggested by available scientific data
and such trials are sometimes referred to as PMCs or PMRs. In the United States, under the Food and Drug Ad-
ministration Amendments Act of 2007 (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 or potential
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 or criminal penal-
ties.
The FDAAA also gave the FDA authority to require companies to implement a REMS for a product to en-
sure that the benefits of the drug outweigh the risks. 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. In determining whether a product will require a REMS, the FDA may consider a number of factors
including:
• estimated size of the population likely to use the product
• seriousness of the condition treated and expected benefits of the product
• duration of treatment with the product
• seriousness of known or potential adverse events associated with the product
• whether the product is a new molecular entity.
All REMS are required to have a timetable for assessment and may have one or more of the following three
elements:
• distribution of a medication guide or a patient package insert to patients
• communication plan for the healthcare provider, such as a Dear Healthcare Professional Letter
• elements to ensure safe use including, but not limited to
Ospecific training, experience or certification for prescribers
Ocertification of medication dispensing sites and dispensing in limited settings
Omonitoring of specific patients
Oenrollment of patients in a registry.
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