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Recalls Put FDA's Power Into Question

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Recalls Put FDA's Power Into Question

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Recalls Put FDA's Power Into Question

Recalls Put FDA's Power Into Question

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News that there may have been more problems than first suspected with drugs like children's Tylenol is leading to questions about the effectiveness of federal regulations regarding recalls. Scott Hensley from NPR's health blog, Shots, talks with Melissa Block about what went wrong at Johnson & Johnson and whether the FDA needs more power to prevent future problems.

MICHELE NORRIS, host:

From NPR News, this is ALL THINGS CONSIDERED. Im Michele Norris.

MELISSA BLOCK, host:

And Im Melissa Block.

Persistent quality problems at Johnson and Johnson have led the company to recall a slew of popular medicines, including liquid Tylenol and Benadryl for children. Yesterday, officials from the Food and Drug Administration and the company were called before a House committee to explain what went wrong. And a new wrinkle in the investigation emerged: The committee raised questions about whether Johnson and Johnson concealed an earlier recall of the painkiller Motrin.

Now, some lawmakers are asking whether the FDA has enough power to keep track of all the products that have problems.

NPR health blogger Scott Hensley is here to fill us in.

And Scott, let's start with this most recent recall, from Johnson and Johnson. They recalled over-the-counter medicines for kids. Why? What was behind it?

SCOTT HENSLEY: That's right. There were metal particles found in some of these medicines, which were liquids. The medicines are liquids. They found some batches that were too strong. And they found overall, a sloppiness in the factory that raised questions about the quality of all the things that were made there.

BLOCK: Back in the '80s, we remember the Tylenol recall. Johnson and Johnson was praised for pulling Tylenol off the shelves after it was found that somebody had tampered with some capsules. The firm had, I guess, a reputation for high quality. What happened to quality control here?

HENSLEY: The agency, the FDA and the company are still sorting that out. Joshua Sharfstein, the second in command of the FDA, said that they were so disturbed by the problems that they found in this factory, outside of Philadelphia, that in February, they brought these things to a head with top management of the company.

But an April inspection by the FDA found even more problems, sparking the big recall. Colleen Goggins, who runs the consumer health business at J and J, said at this hearing yesterday that the situation was unacceptable, and there's been a big shakeup of people at the plant. And they have closed it, in fact, while they're fixing things.

BLOCK: And is that enough to satisfy the FDA?

HENSLEY: Sharfstein said that J and J had gotten the message, but the agency has referred the matter to its criminal investigation unit, and is mulling what other actions it might take.

It's also the case that yesterday's hearing raised a new wrinkle, which was the so-called phantom recall...

BLOCK: Right.

HENSLEY: ...of Motrin last year.

BLOCK: Phantom recall, which is really not a recall at all. Explain what it is.

HENSLEY: Yeah. Well, in this case, what FDA says the company did was to hire an outside company to send people around posing as shoppers to sample these products, get them from the shelves. And originally, the idea was maybe to bring them back for testing. But apparently, what happened was that the shoppers were told: Buy up all the product that you can find and bring it back. And that would, in effect, be a kind of covert recall, according to the committee questioners.

BLOCK: And the committee was troubled by this.

HENSLEY: They were, and so was the agency. The FDA confronted J and J about it, and when they did that, then the company made it into an official recall.

BLOCK: Is the implication, though, that if they could have this contractor buy up all of the medicine on the shelves, they wouldnt have to have a recall even though some of it would have already been sold?

HENSLEY: Right, it would have been secret then. And so the question is, well -and this came up at the hearing - well, how can this be? Can't the FDA tell a company recall that, take it off the market? And in fact, it turns out thats not very easy. Mostly the FDA has to cajole companies to do it. They can go to court, but it's very difficult for them to actually order a recall directly.

BLOCK: Is there any prospect that that could change?

HENSLEY: Yes. In fact, that was a big subject of the hearing yesterday. California Rep. Jackie Speier raised the issue about this, saying there's an elephant in the room - the FDA needs this authority. And right now, there's legislation kicking around on Capitol Hill that is mainly concerned with food safety, but there is a good chance that attention like this could add more power on drug regulation to the arsenal of the FDA, too.

BLOCK: OK. NPR's Scott Hensley, thanks very much.

HENSLEY: Thanks.

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