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FDA Response - Avastin


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Thought this information might be helpful to others here. It was enlightening to me. I sent an email to the FDA yesterday requesting information on when Avastin would be approved for LC. Here is the text of their response:

I am responding to your e-mail to the Food and Drug Administration about Avastin. I am sorry, but under Federal law we are not allowed to provide information about the regulatory status of pending applications. However, FDA does not regulate the practice of medicine, and physicians are free to prescribe FDA-approved drugs for other than FDA-approved uses. FDA also does not regulate health plans, and they are free to cover FDA-approved drugs for other than FDA-approved uses on the basis of reports from the medical literature or other information. You might consult with your doctor's oncologist about providing such reports to his health plan.

The people at FDA appreciate patients' urgent need for new treatments and new uses of existing treatments, and the are working diligently to review such applications in a timely manner.

I hope you find this information helpful. Please contact me if I might be of further assistance.

David Banks

FDA Office of Special Health Issues




Now all I need is for a doctor and and ins. co. to bend over backwards. I will need a miracle for that to happen! Take care. Prayers for all.

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Tina :

I already told you what needs to be done. Actually, if Charlie's med onc had been on top of it he or she would have anticipated this denial and been prepared to provide an argument in support of Charlie NEEDING Avastin. The appeals process varies but the patient usually has the right to appeal such a denial. But, as I stated in my other reply, this appeal should be coming from Charlie's med onc. He or she can provide the necessary medical details, supporting clinical data, influence, etc. to push it thru. Prior to my wife's dx I was a member of a MRC and I saw lots of these appeals. These appeals can be pushed thru very quickly when you've got the doctor's support and he's prepared to say the right things. To be blunt about it, Charlie's med onc needs to step up to the plate and convincingly argue that Charlie NEEDS AVASTIN OR ELSE ...

Good luck.

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I think you missed the point of this post. I was giving information.

FYI, we haven't been denied anything. Unfortunately, not all doctors are willing to stick their neck out and not all of us on here know how things work. I appreciate your advice on how to handle step "C." However, I haven't gotten past step "A."

Charlie's dr. has done an excellent job of staying on top of his treatments and being aggressive. I just need to find a way to help twist his arm so I can even get to step "B." Take care and thanks.

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I probably misunderstood, too. I am sorry. I thought you had been denied. I know what you mean. It IS hard to give "advice" to a Dr. It is for me anyway. Especially if it is a Dr I respect because I don't want to be a pain. BUT, I think the Drs I respect the most see me as a teammate. At least my PCPs do. I haven't had that luck wiht any of the specialists I have seen. And I have seen many.

I just want to wish you both well and let you know I think of you so often.

love and fortitude


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I also misunderstood. We can't help but project ourselves into what we read. And though your intent was only to share info I also "read into it" that you were asking for info on how to accomplish getting Avastin for Tommy. I'm sorry.

Fay A.

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