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![Testosterone Deficiency in the Male Service Member
CPG ID: (TBD]
APPENDIX E: INFORMATION REGARDING OFF-LABEL USES IN CPGs
PURPOSE
The purpose of this Appendix is to ensure an understanding of DoD policy and practice regarding inclusion in CPGs of "off-label" uses of U.S. Food and Drug Administration (FDA)-approved products. This applies to off-label uses with patients who are armed forces members.
BACKGROUND
Unapproved (i.e., "off-label") uses of FDA-approved products are extremely common in American medicine and are usually not subject to any special regulations. However, under Federal law, in some circumstances, unapproved uses of approved drugs are subject to FDA regulations governing "investigational new drugs." These circumstances include such uses as part of clinical trials, and in the military context, command required, unapproved uses. In addition, some command-requested unapproved uses may also be subject to special regulations.
ADDITIONAL INFORMATION REGARDING OFF-LABEL USES IN CPGs
The inclusion in CPGs of off-label uses is not a clinical trial, nor is it a command request or requirement. Further, it does not imply that the Military Health System requires that DoD healthcare practitioners use or consider it the
"standard of care." Instead, the inclusion in CPGs of off-label uses informs the clinical judgment of the responsible healthcare practitioner by providing information regarding potential risks and benefits of treatment alternatives.
The decision is for the clinical judgment of the responsible healthcare practitioner within the practitioner-patient relationship.
Balanced Discussion
Consistent with this purpose, CG discussions of off-label uses specifically state that they are uses not approved by the FDA. Further, such discussions are balanced in the presentation of appropriate clinical study data, including any such data that suggest caution in the use of the product and specifically including any FDA-issued warnings.](https://cdn.bsky.app/img/feed_thumbnail/plain/did:plc:v4jfgpnpcxd2be2hekn5iocf/bafkreihxg6ofj74zqw46syq5v4bua42gqbyawlt5icvnecmzkkbj3hoigy)
