So is it just lack of resources that is keeping FDA quiet?
It also had to do with having an unconfirmed commissioner. When Mark McClellan was commissioner, he was very astute about
being on the offensive and moving lots of initiatives forward. You had a commissioner who focused the energies of the agency
in a way that the outside world had to respond to it rather than the other way around.
Do you see a difference in the messages coming out of FDA now that Andrew von Eschenbach is confirmed?
Absolutely. Before, von Eschenbach wasn't really taking any strong positions. But from the day he was confirmed, he's been
kicking ass and taking names. All of a sudden, he is speaking very strongly about where the FDA needs to go. You're seeing
the real von Eschenbach—the one that turned the National Cancer Institute upside down with some bold statements. I also predict
that he will be aggressive in positioning the agency during the PDUFA [the Prescription Drug User Fee Act] reauthorization,
and he will be strident in his calls to make FDA more of a 21st century organization—one that is focused on personalized medicine,
and has a biomarker-driven regulatory process.
He will also be able to re-energize the senior career staff at FDA because they will realize that they have a champion who
will speak out and speak his mind. When you have an FDA that is not speaking out for itself, you have a pharma industry that
should expect least-worst decisions. And when you start accepting those least-worst answers, you start sacrificing public
In your mind, what's a least-worst decision?
The more I think about Vioxx, the more I'm convinced that it should not have been pulled from the market. Vioxx was a tremendous
opportunity to put forth a responsible argument that drugs have risks as well as benefits and that the public needs to be
better aware of that. But it turned into good versus evil—the public health was served in no way. And when you withdraw drugs
that actually helped lots of people from the market because of political pressure, then you know we're heading in the wrong
When politics drive science, bad things can happen. Just look at how politicians and pundits today are actively calling for
a separation of safety and risk within FDA. I mean, separating risk from benefit? That's ludicrous. How can that possibly
be a good thing?
In all the criticism of FDA, almost no one ever mentions Critical Path or tries to analyze it. Why?
If you were in a room with FDA's biggest critics—elected officials, pundits, and so-called public advocates—and you gave them
a Critical Path 101 quiz, the majority would fail, especially the officials who don't even understand that drugs have risks
to begin with.
Of course, there are those that do. Senator Edward Kennedy, Senator Orrin Hatch, and Senator Michael Enzi understand what's
going on, and they're trying to make things better. Some of the things they propose I agree with and some I don't—but at least
the legislation they put forth is thoughtful.
What do you think of the Enzi–Kennedy bill that's intended to improve post-approval drug safety?
The Enzi–Kennedy bill is bipartisan, which means that there's something in there for everybody to dislike. But I also like
certain things in it, like the proposed Reagan-Udall Critical Path Institute [a public-private partnership whose mission is
to advance the Critical Path initiative and improve drug development]. It would be a tremendous boon to allow FDA to seek
public and private funds to help it do its research and reach out in collaboration.
The Enzi–Kennedy bill also recognizes that FDA needs a lot more money to do things better. The upcoming PDUFA negotiation
is going to be very interesting because clearly, if you don't want industry to fund FDA's user fees, you simply have to raise
taxes. And no elected official has the stomach for that.
But we have to remember that we need to spend the user fees on the things for which they are intended. You simply can't take
the existing funds and spread them thinner and expect things at FDA to get better.
Pet Peeve "People look at FDA and they don't realize that anybody there could walk out the door and triple their salary in a day,"
says Pitts. "They don't because they're on a personal public health mission. To denigrate these people in the way they have
been, it's horrible. So one of my jobs is to stand up for these people and call it as I see it. They shouldn't be expected
to have to do their jobs and fight the political battle at the same time. It's just not fair."