TOPICS > Health

FDA Overhauls Prescription Drug Oversight Program

January 31, 2007 at 6:35 PM EDT
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MARGARET WARNER: Ever since the popular painkiller Vioxx was pulled from pharmacy shelves over safety concerns, there’s been heightened criticism of the way the Food and Drug Administration approves and monitors new drugs.

Last fall, the Institute of Medicine issued a scathing report, saying the FDA’s effectiveness is compromised by internal tensions, outdated procedures, underfunding, and poor management. The report took particular aim at the FDA’s failure to adequately monitor drugs, it said, after they go on sale.

Yesterday, after its own review, the FDA announced it was making more than a dozen changes to improve its drug oversight work. They include: creating a new system to monitor newly approved drugs once they come on the market; and giving agency staff involved in drug safety equal standing with staffers focused on drug approval.

Here to tell us more now is the FDA’s commissioner, Dr. Andrew von Eschenbach. And welcome, Doctor.

DR. ANDREW VON ESCHENBACH, Food and Drug Administration Commissioner: Thanks, Margaret.

MARGARET WARNER: Thanks for being here. Do you consider this a major overhaul in the way the FDA does its work?

DR. ANDREW VON ESCHENBACH: It’s a major step forward in what will be an ongoing process of continuous improvement. The FDA has had a long history of being the world’s gold standard for drug regulation and assuring the safety and effectiveness of drugs.

But the world has changed. And we are in the midst of major changes in medicine, and so the FDA must continuously adapt to the future of health care and ensuring the safety of these products.

Changes in drug trials, monitoring

Dr. Andrew Von Eschenbach
Food and Drug Administration
And even though there are large numbers of patients sometimes in a clinical trial, it's still really a small subset of people. And drugs can act differently in different patients.

MARGARET WARNER: So let's take one that everyone is very interested in, which is how new drugs, once they're approved or actually their safety is monitored, what are you going to change there? How are you going to change it?

DR. ANDREW VON ESCHENBACH: Well, as you know, drugs are approved in the context of an experience in a trial with a select group of patients. And then they are out into the marketplace where they're taken by a large population of patients.

We want to be able to assess, in that situation, in what you would call "post-market," the actual experience of the drug, both its safety, and, in many ways, even its effectiveness.

MARGARET WARNER: And that's because clinical trials, while they take maybe a large group of people, from what I understand, they're all within a certain age range, and often the people don't have multiple conditions the way ordinary people do.

DR. ANDREW VON ESCHENBACH: Right. And even though there are large numbers of patients sometimes in a clinical trial, it's still really a small subset of people. And drugs can act differently in different patients. Patients are taking other medications in other circumstances. And this is now a great opportunity for us to learn more.

MARGARET WARNER: All right, so give us two specific steps you're going to take.

DR. ANDREW VON ESCHENBACH: Well, one of the things that we're doing is a pilot project, where we're using a variety of tools to monitor drugs once they are approved by the Food and Drug Administration and, after 18 months of experience, to take all that information and analyze and assess how that drug is behaving in that population.

It's more of a preemptive step rather than waiting to hear about a problem.

MARGARET WARNER: But by monitor, are you going to be asking doctors all over the country to report adverse reactions? Is that already happening, you're just going to collate it better? What are you really going to do?

DR. ANDREW VON ESCHENBACH: Well, there are multiple steps in ways we'll be able to do this. As you point out, there are opportunities through our adverse-events reporting systems for us to hear from doctors and from patients when there is an adverse event.

There are other systems that we can put in place where we can actively be able to look at isolated databases. We're working with the Veterans Administration, for example, and also for the Center for Medicare and Medicaid Services, to look at their experience and mine that data in a way to get early clues.

Other changes

Dr. Andrew Von Eschenbach
Food and Drug Administration
One of the initiatives, among the 41 that we presented yesterday, broken down according to looking at new science, to be able to predict the safety of these drugs.

MARGARET WARNER: Now, one of the criticisms in the critical report that came out -- the IOM, as it's called, Institute of Medicine -- was that your work is not transparent enough in this area. When you issue this report card after 18 months, who is going to see it? Will the public see it?

DR. ANDREW VON ESCHENBACH: Yes, it will. And we'll be publicizing those events.

One of the initiatives, among the 41 that we presented yesterday, broken down according to looking at new science, to be able to predict the safety of these drugs. Informing and communicating risks more effectively is another important part of our strategy.

MARGARET WARNER: But just to be clear here, this is just a pilot program, so it's not going to be all drugs, and I gather it's not going it start for quite some time?

DR. ANDREW VON ESCHENBACH: We're going to start it in March of this year. We're going to be able to look at drugs. And in the sense of a pilot, we want to determine how to do it well. And we will then be able to do it with a whole host of drugs that we're approving.

MARGARET WARNER: Now, what changes are you making in the way you approach your bread and butter, which is approving new drugs in the first place, the safety of that?

DR. ANDREW VON ESCHENBACH: And the third part of the report was to look at our internal processes and improve those processes, for example, utilizing tools of information technology more effectively, being able to create much more integration between those who are addressing the effectiveness of a drug and those who are addressing the safety issues.

Internal 'tensions' at the FDA

Dr. Andrew Von Eschenbach
Food and Drug Administration
There is always a tension, in terms of, this is a rigorous scientific debate based on scientific evidence, but there will always be judgment and perspective, and we have to balance that.

MARGARET WARNER: Was the IOM report accurate, in your view, when it said that there really was an unhealthy tension between those two sides of the agency and that, when the chips were down, those involved in speeding a drug to approval or getting a drug approved had more clout than those involved in monitoring safety?

DR. ANDREW VON ESCHENBACH: Well, I think the Institute of Medicine pointed out the fact that there is a tension. There is always a tension, in terms of, this is a rigorous scientific debate based on scientific evidence, but there will always be judgment and perspective, and we have to balance that.

MARGARET WARNER: But what are you doing specifically to redress that?

DR. ANDREW VON ESCHENBACH: Well, one of the things we're doing is to provide an opportunity for leadership and oversight of that process, to be able to create opportunities for those differences of opinion to be adequately aired, and then we come to a resolution of a final decision.

MARGARET WARNER: Well, let me ask about a specific examine, because when Congress looked into the Vioxx situation, there was testimony on the Hill that there had been scientists who had expressed misgivings about Vioxx's safety, and they had been basically overruled or were not listened to by FDA managers. Is that going to be corrected?

DR. ANDREW VON ESCHENBACH: Yes. Well, in the sense that we have to have processes in place where differences of opinion can come forward when there are needs for that to come through, an ombudsman function or be brought for resolution, those processes have to be in place.

The next step

Dr. Andrew Von Eschenbach
Food and Drug Administration
We do have to have systems in place where the decisions are always going to be made on the scientific basis of the data, and we will continue to find ways to use new tools to make that even more effective.

MARGARET WARNER: Now, one of the members of the group that issued that previous report was quoted today as saying, "Well, this was a nice first step," but that you really needed to go further, and that, in particular, that the drug safety component or team or project still didn't have the legal authority it really needed.

DR. ANDREW VON ESCHENBACH: Well, as I pointed out yesterday in our release, this is a major step, but it is just a step in what will be an ongoing process of continuing improvement. And we will look later at other opportunities to continue to enhance this process.

We do have to have systems in place where the decisions are always going to be made on the scientific basis of the data, and we will continue to find ways to use new tools to make that even more effective.

MARGARET WARNER: But now you're describing a set of changes that strikes me are going to cost some money and take some staff -- I mean, if you're going to create this new monitoring mechanism and some of these other new things -- yet your budget has been flat. I know this is probably like a softball question to you, but are you going to go ask Congress for more money and more staff?

DR. ANDREW VON ESCHENBACH: Well, the initiatives that we rolled out are all being done within our current resources. There are additional resources that we anticipate that will be coming, for example, through the prescription drug user fee negotiations. And as we go forward, we'll continue to present...

MARGARET WARNER: From the drug companies?

DR. ANDREW VON ESCHENBACH: Yes.

MARGARET WARNER: And do you think these steps are enough to stave off congressional pressure -- and there are some bills floating around -- for a more radical revamping of the FDA?

DR. ANDREW VON ESCHENBACH: Well, as I said, we see this as a part of a larger process. I look forward to that dialogue, to continue to find ways that we can enhance the FDA's effectiveness in our ability to monitor our safety and make those decisions. So I don't see it as an either/or; I see it as complementary to a variety things that we can do.

MARGARET WARNER: Commissioner von Eschenbach, thank you.

DR. ANDREW VON ESCHENBACH: Thank you very much, Margaret.