As I see it

Share this article:
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)

Share this article:
close

Next Article in As I See It

Email Newsletters

More in As I See It

As I See It: Access to data

As I See It: Access to data

We need for pharmaceutical companies to come forward and make the pledge to stop hiding data

As I See It: FDA and the First Amendment

As I See It: FDA and the First ...

FDA's Warning Letter to Aegerion is a bureaucratic thumb in the eye to the US Court of Appeals

As I See It: Small is the new Big

As I See It: Small is the new ...

It's fast becoming an n of 1 world, where every disease is an orphan disease and success is measured by individual outcomes