After listening to a recording of Genentech’s President of Product Development discussing the Avastin/Lucentis controversy with ophthalmologists (see Genentech tries to allay the concerns of ophthalmologists), I posed two questions to the company:
- 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, â€œeven under the new standard, 3 of the 4 [rejected] lots would still be suitable for intravenous use.â€ I donâ€™t understand what she means by this.
Today I spoke with Genentech spokeswoman Dawn Kalmar, who no doubt is getting tired of answering questions on this topic! Nonetheless, she was patient and thorough with me as she has been in the past.
To essence of her answers was as follows:
- By eliminating its contracts with compounding pharmacies, Genentech believes it has done what it can reasonably be expected to do to ensure that Avastin is being used properly.
- The FDA inspector was dissatisfied with the 4 lots based on particulate levels and Genentech agreed to destroy those lots as a consequence of the inspection. Genentech also agreed to a more demanding particulate standard for Avastin manufacturing going forward. Three of the 4 lots in question would have met the new standard but Genentech destroyed them anyway in order to “close out the inspection.” The new standards are intravenous standards, however. “We still can not guarantee ocular standards,” Kalmar told me.
I can’t see how the distribution change Genentech has announced (cutting off direct distribution to compounding pharmacies) will address the FDA’s concerns about Genentech’s manufacturing. Genentech still isn’t making Avastin to ocular standards and Genentech still expects compounding pharmacies to receive Avastin and prepare it for ocular use.
If Genentech had said that they hope compounding pharmacies won’t receive Avastin and that they would be dismayed if that occurred it would be a different story. But they’re not saying that at all.
I wonder what Genentech will do if the inspector comes back and demands that Avastin be made to an ocular standard.November 14, 2007