Senate Plan Would Monitor On-Market Drugs

Iowa Sen. Charles Grassley and Connecticut Sen. Christopher Dodd outlined legislation this past week that would allow the FDA to monitor drugs more carefully after they are put on the market. Their plan calls creating a Center for Post-Market Drug Evaluation and Research. Host Jennifer Ludden talks with NPR's Richard Knox.

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JENNIFER LUDDEN, host:

From NPR News, this is ALL THINGS CONSIDERED. I'm Jennifer Ludden.

This past week marked the beginning of what promises to be a momentous debate on Capitol Hill over drug safety. In recent months two popular arthritis drugs have been pulled off the market. The FDA is requiring strong warning labels on others because studies show increased risk of heart attack and other side effects among users. There's also been concern about whether antidepressant drugs are safe for young people. Now two senators, Republican Chuck Grassley of Iowa and Democrat Christopher Dodd of Connecticut, want to set up a new drug safety center. It would operate within the Food and Drug Administration. Joining me now is NPR's Richard Knox.

Hi, Richard.

RICHARD KNOX reporting:

Hi, Jennifer.

LUDDEN: What exactly are the senators proposing?

KNOX: They're proposing something that they call a Postmarket Drug Evaluation and Research Center. It would report directly to the FDA commissioner. Currently the FDA's Office of Drug Safety is embedded within a division that approves new drugs, and this would be separate.

LUDDEN: What would be the point of a new drug safety center?

KNOX: Well, it's become clear that studies that are typically done before drugs are approved for market often don't predict problems that are going to arise once those drugs get heavily promoted and used by millions and tens of millions of people. And Senator Grassley in particular, who's the powerful chairman of the Senate Finance Committee, has taken a keen interest in this; he's held hearings. The director of this new center could require manufacturers to do new studies of drugs once they're on the market if problems seem to be arising. The FDA can't require that now. He or she could require the drug companies to take action to change the labels, add warnings, restrict who could get the drugs, require education of doctors and consumers if there was an unreasonable risk connected with an already-approved drug. Another important thing that that new center could do is impose monetary fines on drug companies if they fail to comply, and this is a first for the FDA.

LUDDEN: There are also some new restrictions on advertising for new drugs, is that right?

KNOX: Yes, there would be. Right now the drug companies have to obey certain rules with regard to advertising campaigns, ads for both doctors and for the public at large. But they don't have to submit ads to the FDA prior to getting them out there on the air and in the magazines and newspapers and whatever. Under the proposal by Grassley and Dodd, they would have to submit to the FDA these ad campaigns for prior approval. I'm sure this will be controversial. The drug companies are likely to see this as a First Amendment issue. The First Amendment protects free speech, including advertising, and free speech in the United States is not supposed to be under any prior restraint. So that will certainly come up as this proposal goes forward.

LUDDEN: Apart from the advertising issue, how controversial is this proposal for a drug safety center?

KNOX: Well, there are some people, namely consumer advocates, who think it's a great idea. They say it addresses the most serious problems in drug safety monitoring, and they like all the new powers the FDA would have. The pharmaceutical industry, in the form of the Pharmaceutical Research and Manufacturers Association, or PhRMA, says it's still studying the proposal. And it points out that the FDA is already moving to set up a new drug safety advisory board to identify problems with drugs on the market. Critics say that that's not strong enough.

LUDDEN: Any idea yet what the prospects for passage in Congress may be?

KNOX: Well, I think we can expect a lively debate. One cloud on the horizon for the Grassley-Dodd proposal is Senator Mike Enzi, who's a Wyoming Republican. He heads the Senate Committee on Health, Education, Labor and Pensions, and he has jurisdiction over this kind of proposal. He doesn't like the separation of drug safety monitoring from new drug approval. Senator Enzi says that drug risks and benefits should be weighed together, and he claims that the new structure could tip the balance too far toward risk and away from benefits. So we'll see what he has to say about that. He and Senator Ted Kennedy are working on an FDA reform bill of their own, but the shape of that isn't clear. And it's not clear, I gather, what the House will do.

LUDDEN: NPR's Richard Knox, thank you.

KNOX: You're welcome.

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