FDA Urged Toward Tougher Stance on New Drugs

The Institute of Medicine has released a report calling for sweeping changes in the Food and Drug Administration's oversight of new drugs. The FDA has been criticized for recent drug releases that were followed by health issues.

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DEBBIE ELLIOTT, host:

This is ALL THINGS CONSIDERED from NPR News. I'm Debbie Elliott.

A new report recommends significant changes to how the U.S. Food and Drug Administration considers and approves new drugs. The agency has been under fire lately for approving drugs, like Vioxx, that turned out to be dangerous for some people. The FDA requested the report from the Institute of Medicine, an independent body that often advises the government.

NPR's Joanne Silberner is here to talk about some of the recommendations.

Joanne, I understand this report calls for a new way to look at new drugs. What would change?

JOANNE SILBERNER: Well, the idea there is if a drug is really new, that for the first two years after it's approved, the company couldn't advertise it. So that would give doctors and patients, too, a chance to get a little more experience with it. And there would be a seal on the drugs as well that says this is a new drug.

The point here is that when you test a drug, you test it in really nice circumstances. People get clear examinations. They generally only have one condition. When you start putting it out to the public, you get people who are taking four or five other drugs. There are all sorts of things happening with them. You can find side effects, things like Vioxx, what you didn't see in the initial testing.

ELLIOTT: So then if these recommendations went into effect, people would only learn about new drugs if their doctor prescribed them.

SILBERNER: Well, there would be other ways as well. The FDA already is working on ways to put a lot more information on the Internet. They might learn from the media. Who knows? But the idea here would be, let's keep the new drugs to the limited uses until there's more experience with them.

ELLIOTT: The authors of the report also seemed concerned that people be aware that a drug was new and somewhat untested.

SILBERNER: Right. And I think that this was a feeling of a lot of people who watch the FDA, is that there's a risk benefit that the public doesn't get. The FDA gets it. When they approve a drug, they look at the risks and they look at the benefits, but the public doesn't look at the risk. They assume anything approved by the FDA is absolutely safe, and it's not. So this would be another way to get at that idea.

ELLIOTT: Did the report have anything to say about the FDA's oversight role?

SILBERNER: That it wasn't sufficient, that the agency doesn't have enough power. Right now what the agency can do is it can approve a drug and it can take a drug off the market, both very powerful things. But if there's a drug on the market that there are problems with, there's not much the agency can do. So what the report recommended was let it issue fines and injunctions, let it demand further study, and if the study is not done, there are can be penalties to it.

An example of this lack of power came up with a drug for multiple sclerosis. It did very well in testing, did very well when it went out on the market. People who took it loved it. It was a real help, but it killed one out of 1,000 people. Now, people who were taking the drug said it's a risk and we know it, but we want to take it. But the FDA had a drug it knew was killing people. Now, in this case, the company - on its own - said we're going to take this drug off the market till we understand it a little better. They studied it. They figured out some ways to put it back on the market in a more careful way. And they did it.

But had the company not been willing to do that, the FDA would have had a really tough decision on its hand. Do you take away this drug that many people find helpful and say that they're willing to take, even though there's a risk? Or do you take it off the market and make unavailable?

ELLIOTT: Did the Institute of Medicine put a price tag on all of this?

SILBERNER: No, they didn't. And that was - that's something I'm sure everybody would like to know. How much would these recommendations cost? I think in the future there's going to be a lot of talk about the FDA's financing. Clearly, they'll need a lot more money, in addition to which the legislation that now brings in a lot of money for the FDA is coming up for renewal in the year 2007. That legislation allows the FDA to charge its customers - the drug companies - for reviewing its products. And some people aren't comfortable with that idea of the drug companies having to pay the FDA to look at it. That money may go less, with the government having to put in more, or it could go the other way.

ELLIOTT: So what is the FDA saying? What's been the reaction to this report?

SILBERNER: Well, they're very interested in it. They commissioned it, after all. They know that they've got problems. They know that there are morale issues within the agency. They've tried to - and that's mentioned in the report, quite explicitly. They've tried to do some things about those already. They've talked about generating more discussions and allowing more dissention. Some of these ideas they've had themselves. Some of them are new to the agency. I think they're going to consider all of this and see where it goes.

ELLIOTT: NPR health policy correspondent Joanne Silberner, thank you.

SILBERNER: Thank you, Debbie.

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