Experimental Drugs: FSA Eligibility

What are experimental drugs?

Experimental drugs are any substance that has been tested in a laboratory and approved by the U.S. Food and Drug Administration (FDA) for testing in people. Experimental drugs are assessed for safety and effectiveness through clinical trials. A drug may be considered experimental if it’s already approved to treat a specific disease or condition, but is being investigated for its effectiveness in use for another disease or condition. Experimental drugs are often called investigational drugs.

A drug is considered experimental if the Food and Drug Administration (FDA) hasn’t granted approval to market the drug. If the drug is proceeding through clinical Phase I or Phase II trials, it’s also considered experimental. The same applies if the drug is part of the experimental or research arm of a Phase III trial (Verywell Health).

Experimental drugs can also be defined when the written protocol under which the drug is being provided describe its objectives, determination of safety, efficacy, efficacy in comparison with conventional alternatives, or toxicity. Experimental drugs are also designated as such when undergoing studies to change the approved route of administration or dosage of the drug. They also are considered experimental if there’s a change in the approved patient population, or a significant change in the marketing of an approved drug.

Drugs that are considered experimental and are necessary for the treatment of a medical condition are eligible for reimbursement under a consumer-directed healthcare account. A prescription for experimental drugs is required for the expense to be eligible for reimbursement.