In a speech and Q&A session, she struggled to defuse outrage over Genentech's decision last month to restrict distribution of its Avastin cancer med, which is widely used to treat wet macular degeneration, even though the drug was never approved for that purpose. The biotech wants to halt sales to compounding pharmacies, citing FDA concerns about contamination when an Avastin vial is split into different doses.
Opthalmologists complain the move will hurt patients, because the alternative treatment is Genentechâ€™s newer Lucentis, which is approved for the eye disease, but costs 40 times as much, or about $2,000. The decision renewed criticism that Genentech is trying to steer business toward Lucentis at the expense of patients, especially since the biotech wonâ€™t study Avastin for the eye disease (but the NIH is doing so). One doc at the conference called the Lucentis price "eggregious."
"I know people don't believe us and our motives," Desmond-Hellman told the crowd (you can listen here). "I think it's unfortunate you don't believe us. I feel bad about that." She went on to reiterate that Genentech "won't interfere with prescribing choices," and has begun a "dialogue" with the FDA about off-label Avastin use. But she was unable to mollify the crowd when pressed to explain Genentech's reasons for not funding the comparitive trial.
Desmond-Hellman also didn't win any friends when she declined to provide full details of the FDA inspection report that supposedly triggered the distribution decision. And she fudged when asked about the biotech's plan to reinstate its supply of Avastin to compounding pharmacies if the FDA gave the company legal and regulatory authorization to do so. Genentech, as reported previously, hasnâ€™t committed to seeking FDA clearance. This led one doc to say: â€œThereâ€™s a discrepancy between what we hear from the FDA and what we hear from you in terms of what the FDA said to you."
Hat tip to the WSJ Health Blog