In yesterday’s post, I parsed Genentech’s open letter regarding its decision to stop selling Avastin to compounding pharmacies. Genentech implies that the FDA is forcing the company to crack down on Avastin distribution. Once I wrote that, I was alerted to an email that FDA sent to the American Academy of Ophthalmology on October 16, and which was posted on the AAO site. Here it is:
From: Kelly, Christopher
Sent: Tuesday, October 16, 2007 1:00 PM
To: [AAO Representative] Subject: FDA statement on Avastin
Unlike Lucentis (ranibizumab for injection), Avastin (bevacizumab) is not approved for ophthalmic use. However, the Food and Drug Administration (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. Further, FDA continues to monitor adverse reaction reports related to this off-label use. To date, the adverse reactions reported to FDA following use of Avastin for ocular indications have been consistent with the adverse reactions reported for Lucentis. FDA notes that Avastin is a sterile product and that its off-label use for ophthalmic diseases sometimes involves repackaging Avastin into multiple smaller doses for administration. The agency is concerned about the manipulation of sterile products because of the increased risk of product contamination.
Christopher C. Kelly
Office of Public Affairs
Food and Drug Administration
I’ve followed up with emails to Mr. Kelly and to Genentech asking the following questions:
- What are the specific FDA concerns that Genentech is referring to in the following statement? â€œIn order to resolve the concerns raised by the FDA, we destroyed four batches of Avastin deemed unsuitable for use in the eye due to a higher visual inspection standard. (These lots would have been entirely suitable for its approved use as an intravenous cancer medication.)â€
- The same letter says, â€œGenentech also agreed that it would reinstate its supply of Avastin to compounding pharmacies if the FDA gave the company legal and regulatory authorization to do so.â€ Has Genentech requested this authorization or does it intend to? What would have to be done to obtain such authorization?
- The Warning Letter sent to New England Compounding Center on December 4, 2006, states â€œwe are in receipt of a complaint alleging that you are repackaging …Avastin…â€ Who filed that complaint?
- According to the AAOâ€™s letter, Genentech has agreed to â€œNot impede physicians or other legal agents (e.g., group purchasing agents) from ordering Avastin or using compounding pharmacies after the embargo is in place.â€ Is this in fact the case? If so, what is gained from putting an extra step between Genentech and the compounding pharmacists?
Stay tuned. I’ll be sure to let you know what I find out.
PS –A Genentech representative left me a voicemail this afternoon and I hope to connect with her tomorrow.October 31, 2007