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In certain situations, the Food and Drug Administration (FDA) allows companies to provide their experimental drugs to people outside of clinical trials. This is referred to as compassionate use. But getting access to not-yet-approved drugs through a compassionate use request can be a long and challenging process.
If you're interested in trying an experimental treatment, talk to your doctor about your options. For you to receive an experimental drug through the compassionate use program, your doctor must contact the drug company and then submit an application to the FDA. For the FDA to consider your request, you must meet certain criteria:
To find out more about the rules regarding compassionate use, visit the FDA website and search for "access to investigational drugs."
Another way to get access to experimental treatments is through expanded access studies. In these studies, experimental drugs in the later stages of clinical trials are offered to people who don't qualify for the clinical trials. To find out if a drug is available this way, contact the drug's manufacturer. Or go to ClinicalTrials.gov and search for "expanded access studies."
As you consider whether to try to obtain an experimental treatment, it's important to keep a few things in mind:
Last Updated Feb 12, 2020