The incoming FDA commissioner faces something akin to the theme of the old Mission Impossible TV series as the agency admits to yet another management gaffe in its bizarre “disinvitation,” at Eli Lilly's request, of a dissident voice on an advisory committee days before it was to vote on the company's new drug, prasugrel.
Absent that voice, belonging to Sanjay Kaul, a Cedars-Sinai Heart Institute cardiologist, the panel voted 9-0 in favor of prasugrel's approval. Kaul had published his doubts about prasugrel's safety, but could his words have produced an opposite result?
Although the responsible official, drugs director Janet Woodcock, attempted to deflect responsibility to lower-level employees for not following “correct procedure” when they acceded to Lilly's worries, most congressional overseers weren't buying it.
From Reps. Henry Waxman (D-CA) and Bart Stupak (D-MI) to tireless FDA critic Rep. Maurice Hinchey (D-NY), they saw it as another example of regulated industry's growing “clout” at the FDA.
The agency's eagerness to please sprouted in the Bush I administration, progressed through the Clinton administration and blossomed in the deregulatory excesses of the Bush II administration. All this ended in epidemics of unsafe products, and in a corresponding tsunami of criticism for this agency, leaderless for most of the last eight years (no commissioner for 1,622 out of 2,922 days—and now again so).
It's clear that reviving FDA won't be easy. Much as conventional wisdom may have it that this must be too much for any one individual, revitalization has to begin somewhere. As President Harry Truman so famously put it, “The buck stops here”—and so the FDA's helm is where to look for reform to begin.
Dickinson is editor of Dickinson's FDA Webview (fdaweb.com)