Expanded Access/Compassionate use

[musclemania70]

who initiates the patient to begin the compassionate care program? the company in a formal request to the FDA or the physician sends a list of names to the company?
thx!

 

[LouLou]

Are you speaking of a drug that already has a compassionate use clause? If so, your doctor contacts the pharma co. or a local participating cf center regarding enrolling you. It is a leg of the clinical trial and thus you will have to travel to a participating hospital if your own hospital is not participating.

 

[musclemania70]

How do I find out if the drug has a compassionate use clause?

 

[stephen]

Start by contacting your CF center.

I was involved in the Expanded Access program for Aztreonam Lysine (Cayston) for several years before it got FDA approval.

Participation was through my CF center. The center was a participant in the Expanded Access program. Not all centers were. They applied for me and supplied the drug. There was no cost - until it got FDA approval.

Wishing you all the best.

Stephen
70 w/o with CF and Bronchiectasis