IRA FLATOW, host:
Need cause to celebrate today? Well, we've got one for you. One hundred years ago today, President Theodore Roosevelt signed the Pure Food and Drugs Act into law.
Okay. So did that mean? I'll tell you. That laid the groundwork for the nation's oldest consumer protection agency: the Food and Drug Administration, the FDA. And while the FDA is set up to be a consumer's watchdog, critics point out that it hasn't had a permanent commissioner in five years - virtually throughout the entire Bush administration.
Here to talk about the history and current status, or status, of the FDA is Joanne Silberner, who is the health policy correspondent for NPR. Thanks for talking to us today, Joanne.
JOANNE SILBERNER reporting:
Good to be here, Ira.
FLATOW: Thank you. So, what is the history of the FDA? Why did Teddy Roosevelt set this up to begin with? Were things going so bad back there, 100 years ago?
SILBERNER: Absolutely. You remember the medicine shows, snake oils, food was being adulterated, and food colorings were being added to disguise problems in food. Drugs were, I mean, most of the drugs being sold were basically alcohol. So you'd feel better for a little bit, but, you know, overall, nothing was out there that was going to cure you. It was, you know, it was really hard to feel safe about anything you ate or drank back then.
FLATOW: Right, so it was a…
SILBERNER: Unless you grew it yourself.
FLATOW: Of course. I think that's still true today. That's another topic. Of course, then there was a whole string of acts that followed, right?
SILBERNER: Right. And actually, you know, initially the agency didn't have much power. It was actually called the Bureau of Chemistry, and that's what started first in 1906. And basically, the Bureau had the ability to, if something falsely described itself - if a food or a drug was falsely described, sold across state lines, they could step in then. If it were poisonous, it was actually quite hard for them to step in. they lost a number of Supreme Court cases that said, you know, that they were limiting trade or they were limiting free speech.
It didn't have much real power until 1938. That was the Food, Drug and Cosmetic Act. And that came in and said that drugs had to be proven safe: not effective, but safe, before they could be marketed. It wasn't until 1962, there was an amendment that came in and said that a drug had to prove itself effective before it could be sold on the market.
FLATOW: All right, I'm going to ask you to put on your cap, your thinking cap, and come up, for me, what would you say, what would many people say, are the, is the single or the biggest FDA contributions to health to date?
SILBERNER: Well, I think we can feel a lot better about the food and drugs that eat now than we did in 1906. You know, they certainly made things a lot safer. Did they make them safe enough - that's where you can get into some argument or disagreement.
You know, trying to figure out what's safe and what's not safe, especially when you're looking at drugs, becomes a political issue. So, I think in the broad brush look it we're doing a lot better than we were. If you take a finer point to it, we could probably be doing a lot better as well.
FLATOW: Um-hmm. And it has become a political issue, especially in recent years. I'm thinking of this case of, one of the women commissioners, or parse this out for me, who resigned over the abortion pill?
SILBERNER: Right. Yeah, that was, she was in the Office of Women's Health, within the FDA. And what happened was, there'd been a series of decisions made by, or not made by, the FDA that she objected to.
And the biggest one, this was Susan Wood, the biggest issue that she objected to was there had been an application to sell the Morning, so-called Morning-After Pill - it's basically high-dose birth control - a petition to sell it over the counter. And the, actually there have, you said in the beginning there have been no permanent commissioners. There have, there just haven't been a whole of permanent, there's been more often than not, not a permanent commissioner. And what you're asking about now is the answer to that.
It's this issue of selling over the counter birth control. The last commissioner promised that he would take it to, he'd make a decision on it. And then he became appointed - he was the acting commissioner, and he made that promise that he'd make a decision. He got appointed. When the day came for his decision, his decision was, it needed more study.
The current guy, who's the acting commissioner, has just been nominated. This is Andrew von Eschenbach. He's been nominated to be the permanent commissioner. I don't think that the senators who are pushing this are going to buy that thing again, yes I will decide soon by a date certain, because, you know, he could also do that same thing. You know, by the date certain, say gee, I think we need to study it a little bit more. It's become a very contentious issue.
FLATOW: And why can't we keep a commissioner? Is it a political thing, or are there just so many issues that come up that are contentious and the people just throw up their hands and say I'm out of here:
SILBERNER: I think it's a political thing. Mark McClelland, who was Bush's, the president's initial commissioner, probably would've held onto the job for a long time, but he was moved over to run another agency that is somewhat political, the Center for Medicare and Medicaid Services. And then, since then, the two commissioners who've been acting commissioners, you know, the issues for them have been this birth control issue.
And also, the agency has been in, really in the public eye a lot more in the last five years than it ever has been because of issues like Vioxx, and because of issues like antidepressants in kids.
FLATOW: Right. Um-hmm. There's a recent report that was put out by Democratic Representative Henry Waxman that finds that there's been a large drop over the past five years in warning letters sent out by the FDA to companies in violation of federal food and drug safety laws. This, to me, you know, sounds like the FDA is becoming a little bit lax in…
SILBERNER: A lot of people think that. A lot of people. Now this particular report was commissioned by a Democrat, but you should know that the Republicans as well are very suspicious of what's been going on at the FDA. They've done all sorts of studies themselves and had hearings. You've now got, along with Democratic Rep. Henry Waxman, you've got Republican Senators Charles Grassley, Mike Enzi, Democratic Senator Edward Kennedy. All these people have plans that they're pushing that would make, that would, it's funny, they actually don't want to limit the power of the FDA: they want it increased.
They want to increase the naysayer's within the FDA. They want to promote them and give them a little more power.
FLATOW: That's interesting to see that its bipartisan support.
SILBERNER: Yeah, and when you get bipartisan in this particular Congress, you see some action.
FLATOW: And I guess that's because everybody does view the FDA, and rightfully so, as their watchdog. Right? I mean, that's what they're there for.
SILBERNER: Yes. And this agency was absolutely the gold standard around the world. I mean it, dating back to the thalidomide problem in 1962 - it was a drug that was sold in Europe due to lax enforcement there. And in this country, before it went on the market, there was a woman at the FDA named Francis Kelsey, she took a look at the data. She said, this, I don't really like this drug. At great personal risk to herself, she fought the drug's approval, successfully.
It was used experimentally here in this country, which is why you do have some thalidomide babies. She kept it off the market, and that really put the FDA on the road to being known throughout the world as the watchdog, the watchdog agency. That reputation has slipped a little bit in the last five years.
FLATOW: Yeah. There are some things the FDA does not regulate, that we don't, that are not considered drugs, correct? I mean, that may be…
SILBERNER: Well nutritional…
SILBERNER: …they've been severely limited on what they can do about nutritional supplements.
SILBERNER: And that's an interesting issue, because the result is…
FLATOW: Yeah, let's talk about that.
SILBERNER: Well, it's a tough one, you know? The FDA is told by Congress what it can and cannot do. I believe, at least from the people I know within the agency, they'd love to get a lot more involved with nutritional supplements, but they can't. If it's not, if there's not a particular health claim made on the label of the, you know, right there on the label, they can't come in.
I mean, if the label sys it contains this much of this herbal supplement or that much of that vitamin or mineral, as long as it's not a lethal amount they can't do much.
FLATOW: Um-hmm. We're talking with Joanne Silberner on TALK OF THE NATION SCIENCE FRIDAY from NPR News. And we're talking about the history of the FDA.
What most fascinates you, Joanne, about the FDA? The fact that it has been so successful over the years or the fact that it's now just in trouble in a lot of critics' eyes?
SILBERNER: I'd actually take a third option. What fascinates me is they have to walk the line between risk and benefit. And one person's, the risk that one person will take is very different than the risk another person will take.
So you have a drug like Lotronex. This is a drug that treats a condition called Irritable Bowel Syndrome. If you have a severe form of this, you can't be far away from a bathroom. There are people who can't leave the house without this drug. But every once in awhile, it can cause a severe intestinal problem - even death. Should it be marketed? Well, the FDA looked at it, and the data looked a little tough. They came out and they said no. but there was a tremendous public outcry after it was pulled off the market. It went back on the market in limited distribution, you know, the FDA wants to limit it, but it's hard.
Look at Vioxx. If doctors had only prescribed it for the people for whom it was initially approved, which is people with arthritis, people who need to take a painkiller every day over time and may not be able to take the intestinal risks of some of the other painkillers, if it had only been used for them, the risk might have been worth it. But it was over-marketed by the company, it was over-prescribed by doctors, and you had a disaster.
FLATOW: Yeah. Very good point, because I know lots of doctors who would love to give this to patients who have no other choice.
FLATOW: And these patients need it. And they, you know, and its, you're absolutely right. We have this whole situation now with drugs that there are -just so much of it is off-label, is it not?
SILBERNER: Yes, there's an enormous amount of off-label use, and the FDA has attempted to market certain drugs with limited distribution and been unsuccessful, or somewhat unsuccessful.
You take the drug Accutane for severe acne. Not, you know, not the kind that, you know, teenagers go through and will get rid of, but, you know, severe pitting acne. They, if a woman takes it while pregnant, one out of four chances that her baby is going to have a severe deformity. Fine, don't sell it to pregnant women. Well they came up with a registration program - that didn't work. They came up with a new registration program which requires you can only get a one-month prescription, you've got to go back to your doctor, show two negative, you know, two pregnancy test that come out negative.
There are still, it is still happening. You know, people share prescriptions, whatever reason, it is still happening. So what do you do? It's a great drug for the condition…
SILBERNER: …but shouldn't be used in other people.
FLATOW: Well, Joanne, thank you for taking time. I know you're a busy reporter there at NPR. Thank you for taking time to talk with us today and good luck to you.
SILBERNER: Thank you, Ira.
FLATOW: Have a good holiday.
SILBERNER: Thank you.
FLATOW: Joanne Silberner is health policy correspondent for NPR. And that's all the time we have for today.
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