Off-Label Use of Pharmaceuticals

Physicians and other prescribers may prescribe for their patients any legally available medications according to their clinical judgment and expertise. When a medication is used for a purpose other than what is included in the U.S. Food and Drug Administration’s (FDA) approved labeling, physicians rely on available clinical evidence to make decisions on this “off-label” use of a pharmaceutical product. All approved prescribing information for drug and biologic products are required to list all approved medication uses including conditions treated, dosages, routes of administration, and patient populations. For example, a medication that was only approved for use in adult patients may be prescribed to a child as long as the physician exercises best clinical judgment that the medication will be safe and effective to use ...