Off‐label use of medical products in radiation therapy: Summary of the Report of AAPM Task Group No. 121a)

Abstract

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/).

Recommendations of the American Association of Physicists in Medicine on dosimetry, imaging, and quality assurance procedures for 90Y microsphere brachytherapy in the treatment of hepatic malignancies

“…• Only conduct treatments outside vendor recommended indications, which is off-label use, under the supervision of an IRB. 64 VIII.B. Recommendations for future research and improvements:…”

Quality assurance for nonradiographic radiotherapy localization and positioning systems: Report of Task Group 147

“…Guidance on off-label use can be found in the report of the AAPM Task Group 121. 90 The radiation team should also be aware of potential issues that could arise when multiple combinations of addon equipment are used in the same treatment room, such as an add-on MLC, robotic couch tops, and other localization systems. This may require the support of several different vendors in order to verify that all add-on equipment combinations have been tested together, and if not, to get the help of the vendors to design tests to be performed to insure all equipment will work together.…”

Guidelines by the AAPM and GEC‐ESTRO on the use of innovative brachytherapy devices and applications: Report of Task Group 167

“…It is suggested that a thorough review of any innovative brachytherapy device or application should be performed by a qualified medical physicist before clinical research or approval for routine clinical use. The medical physicist must play an active role in the evaluation of risks and benefits of new products or new applications, 27 evaluation of preparedness (resource assessment), and evaluation of the regulatory consequences of clinical implementation when the delivered dose substantially differs from the prescription. For the safe implementation of new technologies, the medical physicist should include the suggestions of this report in his/her department policy manual.…”

“…If an FDA-approved device is to be used for an unapproved clinical indication (i.e., off-label use as described in detail in Appendix A 2) outside of human-use research, 27 The medical physicist should become familiar with the above items if participation is required in a clinical trial using a brachytherapy source or application for research purposes.…”