FDA to hear public testimony in Avastin hearings

[chrisy]

Good news for patients overall, the FDA has decided to allow public testimony to be presented at the hearings on rescinding Avastin's approval for treatment of breast cancer. Hopefully a trend...maybe in the future for TDM1 or other!

you may have to copy/paste the link...

Update from Genentech Patient Advocate re Avastin hearings:

Per your request, here is the information regarding public testimony and a link to our website where all the FAQs about the Avastin hearing are listed.





On the first day of the hearing, June 28, 2011, up to 2 hours of the hearing have been reserved for oral presentations by the general public. If you wish to make an oral presentation during the hearing, you must register by submitting an electronic or written request by May 27, 2011, to Talisha Williams [Office of the Ombudsman, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-8530 begin_of_the_skype_highlighting 301-796-8530 end_of_the_skype_highlighting, email: Talisha.Williams@fda.hhs.gov]. Depending on the number of requests, FDA may not be able to honor all such requests. You must provide your name, title, business affiliation (if applicable), address, telephone and FAX numbers, email address, and (if applicable) type of organization you represent (e.g., industry, consumer organization). You also should submit a brief summary of the presentation, including the discussion topic(s) that will be addressed and the approximate time requested for your presentation.




http://www.gene.com/gene/products/information.html

[hutchibk]

This is good news, but it's all because Gene pushed for it. I have reservations that the FDA will pay any attention at all. They have their mind made up about Avastin IMHO... kind of like when they had the foremost experts on EPO and darbEPO (Procrit & Aranesp) travel in for a hearing in 2007, then didn't ask them one single question, subsequently starting the process of making EPO harder for Oncologists to use for patients in chemo, and making blood transfusions the sloppy, deadly default treatment that costs no less than EPO therapy.

I hope for the best, but because it's the FDA, I expect the worst. Sadly.

[chrisy]

Yep, I also am skeptical - hoping for the best but fearing the worst.