FDA responds on Avastin
November 14th, 2007 by 
David E. Williams of the Health business blog
Just after posting Genentech’s response to my questions, I received an email from Christopher C. Kelly of the FDA’s Office of Public Affairs informing me that he isn’t able to address my specific questions because they are not considered public information. However, he did provide the following statement:
FDA did not ask Genentech to stop distributing Avastin to compounding pharmacies and FDA has not taken action to limit the off-label use of Avastin. FDA has discussed with Genentech developing Avastin for the treatment of macular degeneration and studying its use in ocular indications.
Posted in Pharma, Policy and politics, Uncategorized | 
2 Comments »
November 21st, 2007 at 3:21 am
[...] David Williams of Health Business Blog never fails to impress. This week, his post Some more answers from Genentech even got the FDA to issue a statement. [...]
December 20th, 2007 at 3:57 pm
[...] As reported extensively on the Health Business Blog (see here, here, here, here, here, here, and here ) Genentech has undergone a contentious period with the American Academy of Ophthalmology (AAO) and American Society of Retina Specialists (ASRS). Compounding pharmacies have been repackaging Avastin into small doses, which eye doctors then use in place of Lucentis, a very similar drug from Genentech that is indicated for ocular use. This has been a real headache for Genentech, because repackaged Avastin sells for about $40 compared to Lucentis, which is $2000. The latest controversy was triggered when Genentech announced its intention to stop distributing Avastin to compounding pharmacies. [...]