How can I get access to a drug that is in testing but has not yet been approved?
Drugs that are being tested but are not yet approved are called investigational (or experimental) drugs and patients can get access in two ways:
- They can participate in the drug testing process, known as a clinical trial, or
- They can be given the drug as part of a special program, more formally known as expanded access.
In general, to obtain access to a drug that is in testing but has not yet been approved, a patient must meet the entrance criteria and volunteer to participate in a clinical study of the drug. More information about ongoing clinical trials is available at ClinicalTrials.gov.
Sometimes, people with serious or immediately life-threatening illnesses cannot wait until a drug that could possibly help them stay alive is approved. In some of these cases, FDA authorizes the manufacturer to provide patients with access to a drug that is still being tested for safety and effectiveness but is not yet approved.
FDA does not create expanded access programs; these programs are created by the drug’s manufacturer, sometimes at the request of a doctor whose patient is in urgent need of the medication. If there is no established expanded access program in effect for which the patient qualifies, FDA can consider a request for expanded access on a case-by-case basis.