Genentech tries to clear up Avastin distribution situation
Avastin Distribution Change - Open Letter
I read today’s WSJ Health Blog on Avastin thinking that Genentech had appeased eye specialists by maintaining distribution of Avastin to compounding pharmacies, but after reading the above open letter, I’m confused about Genentech’s actions in the recent past and about what it’s planning to do in the near future. Take a look and let me know if you share in my confusion.
The decision we communicated [to cease Avastin distribution to compounding pharmacies] was not made lightly. In fact, it was guided by our company’s strong commitment to take actions that are scientifically and clinically sound and in the best long-term interest of patients, while at the same time adhering to government regulations and remaining mindful of the retinal community’s views.
The above open-letter snippet suggests that Genentech was motivated by their concerns around the safety of Avastin formulated for intravenous delivery being delivered ocularly. They make this explicit later:
Genentech’s decision was not motivated by a desire for increased profits. We did not and do not expect that this change in policy toward compounding pharmacies will lead to any increase in LUCENTIS® (ranibizumab injection) sales. Further, we expect Avastin to be available and that physicians will continue to prescribe it for ocular indications.
So far, so good. Genentech is making a logical argument. Essentially it’s saying that, like Hippocrates himself, Genentech aims to first do no harm. Fair enough, although I think it’s disingenuous of a for-profit company to imply that an important decision can be divorced from a business case, but I’ll leave that for a future discussion.
Then we get the news that FDA had inspected Genentech’s manufacturing facilities (just when, relative to the company’s compounding-pharmacy decision, we’re not told), and Genentech reacted:
…[W]e 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.) The action resulted in the loss of more than 350,000 vials of Avastin with a market value of more than $200 million.
Now I’m lost. Why would Genentech have to destroy $200 million of Avastin stock intended for use as a cancer therapy (albeit used off-label for other uses, included ocular uses) to appease FDA inspectors? Is Genentech saying that FDA mandated that Genentech produce a product capable of withstanding the same visual-inspection standards required of ocular drugs and that Genentech relented to this mandate without fighting it? Is that what Genentech is saying? Okay, let’s say that’s it for arguments sake. What happens next?
The letter implies that sometime after this self-imposed drug destruction, Genentech made its compounding pharmacy decision and soon after that met with key opinion leaders to revisit the decision (N.B. no mention was made of FDA’s involvement at this KOL meeting). Genentech communicates publicly after this KOL meeting that it will continue to supply Avastin to compounders until at least January 2008 and maybe longer if FDA approves.
In contrast to what was earlier implied by the juxtaposition of the FDA manufacturing/packaging audit and destruction of drug, this latter sequence of events suggests that Genentech’s Avastin destruction was voluntary, not FDA imposed. Why else would Genentech be able to decide unilaterally to continue supplying Avastin to compounding pharmacies–without FDA approval to do so–beyond November, the original date of its distribution cessation? If FDA had ordered destruction of Avastin they would have also, it would seem, had to approve continuation of its supply to compounding pharmacies. Yet, no mention is made of such approval. Indeed, Genentech states that it will continue shipment of drug to compounding pharmacies after January only with FDA approval, again suggesting that FDA is having some say in how Avastin is distributed (or packaged for distribution to compounding pharmacies).
So, I’m left with a bunch of questions that leave me wondering what really happened here and what is going to happen come February 2008:
What did FDA actually find during its audit and what specifically prompted the destruction of a large amount of Avastin intended for use in oncology? Was the destruction voluntary or FDA-mandated? What alternatives to destroying the drug were considered?
What changes to manufacturing/packaging were made following destruction of the drug, and how will such changes affect distribution to compounding pharmacies?
Is an FDA ruling on manufacturing/packaging changes both necessary (as implied in the open letter) and sufficient for Genentech to extend distribution of Avastin to compounding pharmacies beyond January 2008?
Is Genentech planning to change the cost of Avastin for compounding pharmacies? Will there be distinct ocular-specific and oncology-specific formulation/packaging?
When we get some answers to these questions, I’ll post an update.
Disclosure: I have no equity or other financial stake in Genentech or its direct competitors.
