FDA Woes

The Food and Drug Administration remains without top leadership during a tough time for the agency.

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LINDA WERTHEIMER, host:

After hurricane Katrina, FEMA became the federal agency that everyone loves to hate, but there is another agency that hasn't been very popular lately, and the Food and Drug Administration affects the lives of every American every day.

The FDA controls prescription and over the counter drugs, and ensures the safety of our food. NPR's Joanne Silberner joins me to talk about some of the problems plaguing the FDA. Welcome.

JOANNE SILBERNER reporting:

Thank you.

WERTHEIMER: Now, the FDA does not have a permanent leader in place now, and in fact, since 2001 it's been without one more often than not. Why has this administration had such difficulty finding and keeping a Commissioner of Food and Drugs?

SILBERNER: Because the position's become much more political than it ever used to be. The issue lately has been emergency contraception, whether to approve drugs that can be taken within 72 hours of sex that will prevent pregnancy. The last commissioner, it was a big part of his hearings, he promised a decision, and at the date came when his decision was supposed to come, he said, well, what I'm promising you is that we're going to go get more information and then we'll have a ruling. They still haven't. The same issue is going to come up probably in the next commissioner's hearing. The date hasn't even been set yet.

WERTHEIMER: How does Capitol Hill view the FDA?

SILBERNER: With great concern, and with mixed feelings, especially lately. They've been second-guessing the FDA on a lot of issues, on the issue of anti-depressants in kids, they've held their own hearings to find out why the FDA didn't act quicker, or hasn't acted more strongly. They've had hearings on why the agency approved Vioxx.

And now, Senator Chuck Grassley, a Republican from Iowa, is looking into some apparent malfeasance on a new antibiotic called Ketek. The Wall Street Journal documented some real problems in the approval process there, where the FDA knew that some of the data were bad, and yet allowed them to present it to its advisory committee, and approved the drug.

WERTHEIMER: Now, some of the critics complain that the agency is way too cozy with pharmaceutical companies, that it approves drugs quickly and easily. And they point to drugs like Vioxx, which you mentioned as an example. It got quick approval, millions of people used it and then we found out that it was dangerous. Has the agency been too accommodating?

SILBERNER: You can argue that it's been too accommodating, you can argue that it hasn't been accommodating enough. If you talk to some of the groups of people with rare diseases, or with certain types of cancer, they're saying why doesn't the agency let us decide for ourselves. Put the drug on the market, let us try it. With Vioxx, the issue is as much, the agency did approve it quickly under great pressure from the drug companies. Doctors over-prescribed it, so that created a problem. The drug companies over-pushed it because the FDA no longer has ability to really limit, it does limit to some degree, direct to consumer advertising, but not that much. So in that case it was a combination of a lot of groups not fully doing their jobs, which allowed that drug to go on.

WERTHEIMER: How is morale at the agency?

SILBERNER: The people I deal with are a very dedicated, hard-working group of people, and they haven't looked too happy lately. I think they are a few people in there who haven't really stuck to the science closely enough, or have allowed politics to come in, and I think it's - the other people in the agency are quite upset.

WERTHEIMER: So despite this, do you have the sense that the FDA is doing its job in protecting our food and ensuring the safety of drugs, or should we be worried?

SILBERNER: Well, I think you should always worry when you take a prescription drug. You should only take a drug if it is needed. There are doctors around who won't prescribe a drug in the first couple of years it comes on the market. That's probably a good idea. There are certainly some drugs that have gotten onto the market that have been questionable, in some cases because the FDA wasn't rigorous enough. In other cases, it's because you can test a drug in 10,000 people, and it's that 10,001st where the problems start.

WERTHEIMER: Thanks very much. NPR's Joanne Silberner. We appreciate it.

SILBERNER: Thank you.

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