Remember last year when Genentech said it wouldn't sell its cancer med Avastin to compounding pharmacies, which repackage it for off-label use in patients with macular degeneration--and then blamed the FDA for the change? Well, Genentech ended up backing down a bit. But it never stopped stressing the fact that the restriction was FDA's fault. The company flatly denied that it was trying to protect Lucentis, its drug approved for use in macular degeneration, which just happens to cost roughly $2,000 per treatment course versus some $50 for repackaged Avastin.
Now, though, a Senate investigation appears to show that Genentech's blame game was unfounded. The company had claimed that agency inspectors were concerned that some batches of Avastin didn't meet standards for ophthalmic use, but the agency says they didn't meet standards, period. Inspectors “identified deficient practices and the lack of of effective processes to know what was in those four lots," the agency wrote Senate investigators. "Consequently, the Agency recommended that those lots should be considered unfit for use for any indication.” Genentech disputes this, saying that the lots were OK for cancer use.
When Genentech started citing FDA for its distribution change, some officials were miffed. "Genentech has found a way to blame FDA for their decision to limit their distribution of Avastin," an official wrote.
Curiouser and curiouser, FDA declined to expressly limit the use of Avastin. When Lucentis was approved, Genentech asked the FDA to change Avastin's label to say that the drug was not for ophthalmic use, according to an internal FDA email obtained by the Senate. The agency concluded there was "no safety-related basis adequately justifying that labeling change."
- read the (lengthy) Wall Street Journal Health Blog post