Off-label use of medical products in radiation therapy: Summary of the Report of AAPM Task Group No. 121
2010
Medical products
(devices, drugs, or biologics) contain information in their labeling regarding the manner in
which the manufacturer has determined that the products can be used in a safe and
effective manner. The Food and Drug Administration (FDA) approves medical products for use for
these specific indications which are part of the medical product’s labeling.
When medical
products are used in a manner not specified in the labeling, it is commonly referred to as
off-label use. The practice of medicine allows for this off-label use to treat individual
patients, but the ethical and legal implications for such unapproved use can be confusing.
Although the responsibility and, ultimately, the liability for off-label use often rests
with the prescribing physician, medical physicists and others are also responsible for the safe and
proper use of the medical products. When these products are used for purposes other than
which they were approved, it is important for medical physicists to understand their responsibilities. In
the United States, medical products can only be marketed if officially cleared, approved,
or licensed by the FDA; they can be used if they are not subject to or specifically exempt
from FDA regulations, or if they are being used in research with the appropriate
regulatory safeguards. Medical
devices are either cleared or approved by FDA’s Center for Devices and
Radiological Health. Drugs are approved by FDA’s Center for Drug Evaluation and Research,
and biological products such as vaccines or blood are licensed under a biologics license
agreement by FDA’s Center for Biologics Evaluation and Research. For the purpose of this
report, the process by which the FDA eventually clears, approves, or licenses such
products for marketing in the United States will be referred to as approval. This report
summarizes the various ways medical products, primarily medical devices, can legally be brought to market in the
United States, and includes a discussion of the approval process, along with
manufacturers’ responsibilities, labeling, marketing and promotion, and off-label use.
This is an educational and descriptive report and does not contain prescriptive
recommendations. This report addresses the role of the medical physicist in clinical
situations involving off-label use. Case studies in radiation therapy are presented. Any
mention of commercial products is for identification only; it does not imply
recom-mendations or endorsements of any of the authors or the AAPM. The full report,
containing extensive background on off-label use with several appendices, is available on
the AAPM website (http://www.aapm.org/pubs/reports/).
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