Compassionate Use And Expanded Access Programs

If the FDA approves, pharmaceutical companies can set up a formal expanded access program for drugs that have been studied and are in the approval process. These programs permit access to the drug before FDA approval, but outside of a clinical trial.

When a pharmaceutical company sets up an Expanded Access Program, it submits a protocol to the FDA including criteria for people to qualify. If you fit within those criteria, nothing further needs to be done to permit you access to the drug. If you do not fit within those criteria, an alternative way to obtain the drug is through the Individual Special Exemption discussed in the next section.

To locate an Expanded Access Program (EAP) that works for you:

• Ask your specialist.
• Look at the website of the manufacturer of a particular drug in which you are interested
• Speak with patient advocacy organizations that specialize in your disease.
• If you have cancer: a Web page that lists expanded-access programs for people living with cancer is www.canceractionnow.org . Cancer Action Now is a nonprofit that helps patients learn if they can gain access to experimental drugs.
• Look at www.clinicaldrugs.gov The site provides regularly updated information about federally and privately supported clinical research in human volunteers, including information about a trial's purpose, who may participate, locations, and phone numbers. Or call 800.INFO.FDA.

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