The primary role of this section of labeling is to enable health care practitioners to readily identify appropriate therapies for patients by clearly communicating the drug's approved indication(s).
The Indications and Usage section states the disease or condition, or manifestation or symptoms thereof, for which the drug is approved, as well as whether the drug is indicated for the treatment, prevention, mitigation, cure, relief, or diagnosis of that disease or condition.
Drug companies can not provide any official medication information (e.g. package inserts) for off label indications.
[2] The purpose for adding FDA-approved indications in the United States is to ensure that healthcare providers can easily identify appropriate use of drug therapy.
[10] Gaining FDA approval is based on the body of scientific evidence supporting the effectiveness of a drug treatment.
[12][13] Essentially, if it is found that there is substantial evidence that benefits of treatment outweigh the risks, the proposed labeling in the Prescribing Information is appropriate, and the manufacturing process is safe and adequate, then the drug is approved to go to market under that now FDA-approved indication.
[15][20] Concerns were therefore raised that patients and insurers may be paying too high prices for indications with a relatively low clinical value.
[26] Italy on the other hand, uses a model similar to indication-based pricing where the amount the hospital pays for certain drugs varies based on what it's used for.
[25] Patients can receive reimbursements for treatments based on their response and either be fully or partially refunded.
[17] There has been some thought on incorporating the indication in prescription drug labeling as an approach to improve patient understanding of the medications they are on.
This information can help healthcare providers reduce medication errors related to drugs that may look and sound alike.