To show, or not to show? Opening a new front in a policy warzone about FDA secrecy, Genentech found in October that it had a regulatory “tiger by the tail” in trying to keep secret an FDA approvable letter it had received for Avastin, while at the same time trying to enlist patient support for early approval against an FDA delay.
It was an unexpected poster-child for a long-running battle between the FDA and many outside groups over the agency’s growing penchant for secrecy while paradoxically promising new “transparency” in response to such criticisms.
Genentech ran into the controversy after it received a non-public “complete response” (formerly “approvable”) letter from the FDA asking for more information on Avastin clinical trial data than the company said had been agreed upon, before approval for a new indication could be granted.
Genentech said providing this would bring a major delay, so in a bid to change the FDA’s mind it asked patient advocacy groups who had helped with the trial to lobby the agency. Instead, the groups pushed back, wanting to see the FDA’s non-public letter so they could judge its reasonableness for themselves. Genentech refused, and so presumably got no help from them.
Given the toxic publicity that the combination of secrecy and drug safety created in the Vioxx controversy, the all-too-common posture by Genentech is disappointing.
The broader issue all along has been that this kind of information about drug safety should not be secret—especially when the drug is already on the market and is possibly being used off-label for the pending indication.
The law ties the FDA’s hands, but not the sponsor’s. Yet their customary stance is to hold this tiger by the tail until it bites them.
Dickinson is editor of Dickinson’s FDA Webview (fdaweb.com)
From the November 01, 2006 Issue of MM+M - Medical Marketing and Media
