If you haven’t been following the story, Genentech has decided to stop selling Avastin directly to compounding pharmacies. The problem: pharmacists can repackage Avastin for use in the eye and sell it for $40, thus undermining sales of Lucentis, an almost identical drug also made by Genentech that sells for $2000. To add insult to injury –at least from Genentech’s standpoint– FDA is insisting that Genentech manufacture Avastin to a higher, ocular standard. As a result Genentech had to destroy millions of dollars worth of product. I’ve covered this topic here, here, here and here. In summary, ophthalmologists and patients are peeved at the decision while Genentech feels it’s bent over backwards to accommodate their concerns.
Over the weekend, Genentech’s President of Product Development, Dr. Susan Desmond-Hellmann addressed a somewhat hostile crowd at the American Academy of Ophthalmology’s annual meeting.
After listening to the recording, I still have a couple of questions:
- Genentech says explicitly that they expect compounding pharmacies to continue to have access to Avastin, just not directly from the company. Why do they think this will be sufficient to get the FDA to back off?
- Desmond-Hellmann says that Genentech has agreed to a new manufacturing standard for Avastin, which addresses particulates specifically. She then says, “even under the new standard, 3 of the 4 [rejected] lots would still be suitable for intravenous use.â€ I don’t understand what she means by this.
I’ve emailed these questions to Genentech and will post an update when I have clarification.
Meanwhile I’ve called FDA again because I am still waiting for a response to (or even acknowledgment of) my email from October 31.November 13, 2007