HER2 Support Group Forums - View Single Post - FDA Blocks Life-Saving Cancer Drug Rally

phil · 12-04-2011, 07:46 AM

Expanded Access is NOT comp. use ! Single pt access is . " Comp. Use " is a name given by Congress to that part of the Acc. Approval Program, wher apt's Dr. asks the co for single pt. access. Co's are reluctant to give it, as I stated above, risk of un-related health probs. Gen. does NOT give any compassionate use for this drug. We are very happy that you got into the T DM-1 EAP. Gen. was going to close it last Oct 31, until we had our Sen. Kerry's office and Congr. Stephen Lynchs' office call. Plus an old friend of Ted Kennedy. Thanks to them , Expanded Access was kept open , until Sept. 6th, 2011.
We wouldnt be having to have this discussion except for This FDA. But everything happens for a reason, and it brought to light how Big Business Selling Medicine needs regulation. Past experiences w/ the original herceptin Lottery, denying Stage Iv pts single pt. access, even current med . shortages ( because theres no $ in generics ) , all point to the need for some regulation.
We are not anti-business , or anti- govt, but pro-patient !

12-04-2011, 07:46 AM	#9
phil Senior Member Join Date: Nov 2010 Posts: 393	Re: FDA Blocks Life-Saving Cancer Drug Rally Expanded Access is NOT comp. use ! Single pt access is . " Comp. Use " is a name given by Congress to that part of the Acc. Approval Program, wher apt's Dr. asks the co for single pt. access. Co's are reluctant to give it, as I stated above, risk of un-related health probs. Gen. does NOT give any compassionate use for this drug. We are very happy that you got into the T DM-1 EAP. Gen. was going to close it last Oct 31, until we had our Sen. Kerry's office and Congr. Stephen Lynchs' office call. Plus an old friend of Ted Kennedy. Thanks to them , Expanded Access was kept open , until Sept. 6th, 2011. We wouldnt be having to have this discussion except for This FDA. But everything happens for a reason, and it brought to light how Big Business Selling Medicine needs regulation. Past experiences w/ the original herceptin Lottery, denying Stage Iv pts single pt. access, even current med . shortages ( because theres no $ in generics ) , all point to the need for some regulation. We are not anti-business , or anti- govt, but pro-patient !