2005P-0400 permission to Donna Ricks to contine using Palladone for severe chronic pain due to stage 4 metastic breast cancer
FDA Comment Number : EC2
Submitter : Mr. Dave Lowe Date & Time: 12/13/2005 10:12:41
Organization : Mr. Dave Lowe
Category : Individual Consumer
Issue Areas/Comments
Donna Ricks needs Palladone for severe chronic pain due to Stage 4 Metastic Breast Cancer. It has spread to her lungs, bones, and liver.

This is an example of everything wrong with FDA if not handled already. This could be handled privately without the need for even posting the petition.

Someone at FDA can pick up the phone and call Purdue Pharma on behalf of someone they serve and give the dignity of a yes or no. This could happen in very, very, short order and with no need to even post the petition if available. Let the individual assume all responsibility for using the drug, and prove medical need as fast as they can. Purdue and the petitioner can communicate if it is available and work out the details.

Acting Commisioner is from the National Cancer Instititute, and someone has cancer that has spread to the lungs, bones, and liver. If Donna Ricks didn't have an answer about Palladone in a few days, The Acting Commisioner was asleep. Nice job if that happened, however go back to sleep.