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There are lots of politicians, Senators Grassley and Waxman to name just two, who often say FDA is in the pharmaceutical industry's pocket. But anybody that has ever worked with FDA realizes not only is that not right, it's comically wrong.
Peter Pitts writes to a mostly silent readership. He's the chief voice of DrugWonks.com, a blog hosted by the Center for Medicine in the Public Interest, a nonprofit focused on challenging drug policy and the industry's critics. Although more than 150,000 people log on each month to read Pitts' often-provocative entries, most execs are too afraid of the spotlight to respond. Pitts considers these readers part of the "silent majority"—the employees in the pharma industry and FDA who, when attacked, won't fight back.
Taking on the critics has become somewhat of a personal mission for Pitts, who was formerly FDA's associate commissioner for external relations, and is now senior vice president for global health affairs at the PR firm Manning, Selvage & Lee. He's bent on getting industry to stand up and speak its mind—and he leads by example. His blog takes on politicians, journalists, medical journals, or, he says, "anybody out there with a score to settle."
Here, Pitts urges pharma to continuously plug its positions and get politics out of science, and offers some perspective on important regulatory reforms facing FDA.
Pharm Exec: Pharma has been burned so many times by the media. Why do you expect them to speak up and get different results?
Peter Pitts: When did it happen that FDA moved from protector of the public health to villain? It's only because people who choose to paint the industry and paint the FDA in those colors had the field all to themselves. Those people are more than happy to speak and write and almost put graffiti on the subways to get their messages out.
On the other side, the pharma industry is in a pickle because they've kept quiet. They've worked behind the scenes. They've lobbied. But if you don't say anything, don't expect people to understand your argument. It's too late to step forward when a congressional committee is loaded, the public is against you, and the media's looking for blood—that's not a recipe for success.
What's the most damaging argument out there now?
There are lots of politicians, Senator Grassley and Representative Waxman to name just two, who often say FDA is in the pharmaceutical industry's pocket. But anybody that has ever worked with FDA realizes not only is that not right, it's comically wrong. Although the agency has to be both colleague and regulator, when an FDA person walks into a pharma company's lobby, that building shakes.
I'll tell you a true story. After I left FDA, I paid a social call to a friend of mine at Pfizer. I'd been to Pfizer when I was at the FDA, so my name was in the databank. I walk into the building and I say, "I'm here to see so-and-so." They type in my name and they ask me to wait. Within two seconds, five people come running into the lobby wanting to know if they can help me. They must have tapped a little FDA emergency button. So it's just a small example, but it does show how the industry lives in fear of the FDA.
But these sorts of arguments are out there because FDA and the pharmaceutical industry haven't done anything to counteract them. The FDA doesn't have the money for any type of outreach budget, and they say they're busy—but that's not an excuse. And when it comes to the pharmaceutical industry, they need to learn to go beyond just creating a public affairs initiative—they need to actually live it.
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 health.
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 direction.
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."