Compassionate Use And Expanded Access Programs

There is no guarantee that you will be able to continue to take a drug or treatment during the period after a clinical trial ends until the drug or treatment is approved by the FDA. As noted elsewhere in this document, you may be able to obtain the drug as a "compassionate use."

The investigator, the Institutional Review Board (IRB) that oversees the clinical trial, and the drug maker must agree to provide you the drug.

The place to start is with the drug maker. Either the drug maker or your doctor will then get the approval of the investigator and the IRB. Either the drug maker or your doctor will then approach the FDA about your particular situation and ask for a "single patient IND" granting permission to treat you with the drug.Once the drug maker agrees, it will

Your doctor is the appropriate person to contact the drug maker or person running the clinical trial (the "investigator) to request a compassionate use of a drug or treatment. Your doctor will also be asked to provide medical and treatment history.

Do whatever you can to help your doctor in this process. For example:

• Some patients do the leg work to schedule a time for the doctor to call the correct person at the drug maker.
• If your doctor won't take charge of helping you get a compassionate use of a drug, at least ask for a letter describing:
  • Your condition 
  • The treatments that have been tried
  • Why the drug you are requesting is so important to you and your health.
• It may be up to you to find the person at the drug maker who decides who receives single-patient access and who doesn't. Generally this is the medical director for clinical development.

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