Compassionate Use Program

 

What Is the Compassionate Use Program?

A formal compassionate use program is a mechanism for getting an unapproved but promising new treatment to patients who would otherwise be unable to receive it. Compassionate use programs are for people who have a life threatening with "no comparable or satisfactory alternative drug or other therapy available to treat that stage of the disease in the intended patient population" (in the words of the FDA regulations).

Formal compassionate use is a bit like a clinical trial in that you will still have to meet specific requirements such as the type and stage of disease, and usually you must be treated by doctors who participated in the clinical trials for the drug, but compared to trials, the requirements are somewhat relaxed. If you qualify for an open clinical trial of the treatment, obtaining it through compassionate use is not an option.
(Information provided by CancerGuide.org)

 

Physician Request for a Single Patient IND for Compassionate or Emergency Use 

• Single Patient IND

 

What can I do to assist my physician?

1. Contact the pharmaceutical company to request use of specific drug.
   
   
2. Review information on how to Access to unapproved drugs http://www.accessdata.fda.gov/scripts/cder/onctools/access.htm
   
   Emergency and Treatment INDs are also known as "Compassionate" INDs, but the term "Compassionate" is not in the IND regulations.
   
   
3. Complete the following forms:
   • Emergency Investigational New Drug Application (EIND) Information Request Form [PDF] [Word]
   • Form FDA 1571 [PDF] [Word]
   • Form FDA 1572 [PDF] [Word]
     
     
     
     For further information, please contact the appropriate Review Division
     
     

     Office or Division	Phone	Fax
     CDER Antiviral Products	(301)  796-1500	(301)  796-9883
     CDER Oncology Drug Products	(301)  796-2340	(301)  796-9909
     CDER Reproductive and Urologic Products (for prostate cancer hormones)	(301)  796-0950	(301)  796-9897
     CDER Medical Imaging and Hematology Products	(301)  796-2050	(301)  796-9848
     CDER Gastrointestinal Products	(301)  796-2120	(301)  796-9905
     CDER Analgesics, Anesthetics, and Rheumatology Products (most pain medications)	(301)  796-2280	(301)  796-9723
     CDER Metabolism and Endocrinology Drugs	(301)  796-2290	(301)  796-9722
     Center for Devices and Radiological Health (CDRH)

     
     

References

Food and Drug Administration

Off-Protocol: Getting New Treatments Outside a Clinical Trial

CancerActionNow.org

Last update Aug. 2008