Article preview from The RPM Report April 28, 2009
FDA is the first to acknowledge that a lot of things went wrong during the run-up to the prasugrel advisory committee meeting, not the least of which is how the agency handles allegations of intellectual bias among its members. For drug sponsors, it may mean that the rules of engagement have changed.
Article preview from The RPM Report April 28, 2009
FDA is the first to acknowledge that a lot of things went wrong during the run-up to the prasugrel advisory committee meeting, not the least of which is how the agency handles allegations of intellectual bias among its members. For drug sponsors, it may mean that the rules of engagement have changed.
In the eyes of critics of the Food & Drug Administration, a lot of things went wrong during the advisory committee review of Eli Lilly & Co./Daiichi Sankyo Co. Ltd.’s platelet inhibitor prasugrel (Effient).
An advisory committee member that had been skeptical of prasugrel’s efficacy was “disinvited” after Lilly raised the potential for intellectual bias. Not a single drug safety expert participated in the meeting—despite an application whose approvability seems to hinge on how the agency balances strong efficacy data against the potential for significant risks. And, last but not least, the committee heard only from one high-level official about prasugrel’s benefits and risks, despite internal dissent within FDA about a potential cancer signal.
Talk about a perfect case study for critics of FDA and industry. They see an agency that suppresses internal dissent, an advisory committee process that can too easily be stacked for or against an application, and an industry that has too much influence and control. Prasugrel seems to confirm all those complaints. No wonder a congressional committee has opened up an investigation into the “disinvitation” of a prasugrel advisory committee member.
FDA, of course, sees it differently, and the agency has logical explanations for every aspect of the committee review—including the role of simple human error in “disinviting” one member. But the fact that FDA officials even have to make explanations illustrates the credibility crisis that the agency—and its advisory committee system—continue to face.
Ironically, the February 3 meeting itself went very smoothly. Prasugrel is a high-profile, commercially vital application, and when the committee adjourned—having voted overwhelming in favor of approval, it looked like a huge sign of progress from industry’s perspective: a demonstration that an FDA advisory committee’s discussion of a tricky product application can be smooth and productive.
What the prasugrel review shows now, however, is that even the smoothest committee review does not necessarily exclude the possibility of a backlash after the meeting is over.
For Lilly, the post-meeting controversy means that the company is likely to experience a further delay in a final decision on prasugrel until FDA responds to the congressional inquiry. But it also underscores the much bigger problem for industry and FDA as a whole: restoring the integrity of a cornerstone of the approval process.
It is hard enough to get a product through an advisory committee. Now sponsors have to prepare for the possibility that a review can be too smooth—and even the appearance of meddling by industry can prove toxic. That standard may not be fair, but industry would do well to learn from Lilly’s example. FDA has admitted error in its handling of the committee, but—in hindsight—Lilly also erred in working too hard to avoid a rocky review.
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