Editing Off-label use (section)

==Indications and labeling laws==
{{unreferenced section|date=March 2020}}
An ''[[Indication (medicine)|indication]]'' is when a drug is medically appropriate for a given condition; an approved indication is when a government [[drug regulatory agency]] formally agrees that the drug is medically appropriate for the named condition.  Indications may depend not only upon the medical condition that is being treated, but also upon other factors, such as dose, the patient's age, size and sex, whether the patient is pregnant or breastfeeding, and other medical conditions.  For example, aspirin is generally indicated for a headache, but it is not indicated for headaches in people with an allergic reaction to it.

When the drug's manufacturer has received a [[marketing authorisation]] from the government agency, then it is allowed to promote the drug for the specific, agreed-upon approved indications in that country.  All legally approved indications are listed on the drug [[package insert]] or "label". Drug manufacturers are not legally permitted to encourage the use of regulated drugs for any indications that have not been formally approved by the country's government, even if significant scientific evidence exists for that unapproved indication, or if another country's drug agency has approved that indication.

However, healthcare providers are not required to limit prescriptions or recommendations to the indications approved by their country's drug regulatory body. In fact, the [[standard of care]] for many conditions involves off-label uses, either as first-line therapy or as a subsequent line. In other words, properly understanding why off-label use is common and usually appropriate, rather than rare and usually inappropriate, requires understanding that the distinction between regulatory-agency-approved use versus off-label use is not the same distinction as safe versus unsafe, tested versus untested, or good versus bad; it is a marker of ''increased certainty'' about a use being good (safe and effective), as opposed to less certainty—rather than a marker of good as opposed to bad. Regulatory approval for an indication requires a body of evidence that costs money to assemble, and as with [[evidence-based medicine]] generally, the desire for a vast, high-quality evidence base is an ideal that real-world practice can only aspire to and further approach, rather than completely match; there may not be enough resources to test every drug for every possible or logical indication to an exhaustive degree. Regulation of [[therapy freedom]] thus takes [[everything which is not forbidden is allowed|an approach in which anything not explicitly forbidden is allowed rather than an approach in which anything not explicitly allowed is forbidden]], and it is accepted that drugs may be used in off-label ways as long as a competent professional prescribes them.