FDA Commish Serves Some Dish
2 CommentsBy Ed Silverman // February 21st, 2007 // 1:21 pm
Andy von Eschenbach was the luncheon speaker at an industry conference in Washington DC today (and yes, Pharmalot participated on one of the panels, but more on that later) and he opened up a wee bit - just a wee bit. His main theme was improving communication.
Unfortunately, his speaking style ranges from disarming and casual to something that can only be described as bureaucratic tongue disorder - Andy talks way too much about processes, mechanisms and systems. Vague stuff if you’re not a Beltway insider.
But there was this: He promised to open up to the media. “There will be ongoing efforts within the next weeks to have a dialogue with the media.” Not sure what that means. Will the FDA finally make an updated list of press contacts? One can only hope.
On the topic of DTC ads, Andy concedes “there’s a right of free speech….What we need to do is make sure the content of what’s being exposed (to the public) is factual and accurate.” Good idea, but not a new one. Now, if the FDA would act on that thought….
Andy was demur about user fees. With debate over renewing the Prescription Drug User Fee Act - PDUFA to those of you in the know - that’s hardly surprising. But he downplayed their significance. The fees are “very discreet…they’re a useful and important part of the resource base, but just one part.” Well, the FDA wants more user fees, no? That’s hardly discreet.
As to transparency, von Eschenbach said he’s all for it. But he contends the average citizen doesn’t need or want to know about every little piece of information the FDA gets from companies. “They don’t need to know all the details of the data…They need to trust the integrity of the process.” Another school of thought says more info is better than less info.
And when it comes to agency whistleblowers, the commish talked tough. “To go outside the process is destructive, not constructive….They aren’t speaking in the best interest of the FDA….I expect people to adhere to that, because that’s the way to do business. Otherwise, it’s chaos.” There will always be a whistleblower, though, unless one creates climate change.
Oh, yes. The roasted veggie sandwich was quite nice.
[tags]Andrew von Eschenbach, FDA[/tags]
Melody
“To go outside the process is destructive, not constructive….They aren’t speaking in the best interest of the FDA….I expect people to adhere to that, because that’s the way to do business.
When whistleblowers magnanimously decide to act in the best interest of CITIZENS instead of the FDA, they shouldn’t be punished. The FDA has a long history of giving economic corporate interests precedence over American citizens well-being. Oh–they’ll eventually get around to doing the right thing, but every day they delay–whether it be requiring post-marketing data collection, black box warnings, or market withdrawal–the economic benefit to the manufacturer outstrips the legal liability.
These arroganct utterings by von Eschenbach regarding “the average citizen” belies his “transparency” issues. I have seen nothing to change my opinion than this agency remains just whatt other journalists have so aptly labeled it–a LAPDOG for Big Pharma..
ed
Preventing whistleblowing is a diffciult thing. The real issue is the environment that encouarges some people to believe that’s the only route for disclosing information.
That may require a complete makeover at the agency’s higher echelons. For any FDA commish, the challenge is to alter the goals and thinking that made some staffers feel there were no alternatives.
Several agency employees took this route - either publicly or by seeking out journalists - over the past few years, going back to the Rezulin controversy. That’s a sign of systemic problems.
Rather than blame the individuals, an effective leader will examine why so many agency staffers felt compelled to speak out. Whether von Eschenbach actually cares about this remains to be seen, but it takes more than telling employees to get in line for the sake of running a tight ship.