FDA Asks Drug Maker To Pull Opioid Opana ER Off The Market

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ROBERT SIEGEL, HOST:

Yesterday the U.S. Food and Drug Administration asked the drug maker Endo Pharmaceuticals to stop selling the prescription drug Opana ER. It's a potent opioid painkiller, and like OxyContin, it's been heavily abused. Joining us now to talk about the FDA's move is Janet Woodcock. She is director of the FDA's Center for Drug Evaluation and Research. Welcome to the program.

JANET WOODCOCK: Thank you.

SIEGEL: The FDA came to this decision after determining that the risks of Opana ER outweigh the benefits. Can you elaborate on that finding? What are the risks?

WOODCOCK: The risks that this decision was made on have to do with the risk of abusing the product. And people who were abusing Opana ER developed several serious problems. One was we had outbreaks of HIV and Hepatitis C from sharing the drug after it was extracted by abusers. Second, there was a outbreak of a serious blood disorder.

SIEGEL: And when you say the way in which it was used, you mean it was being injected, actually.

WOODCOCK: That's right. It was being injected, and you were injecting those materials that were added to try to make it more abuse-deterrent. But I will add, the FDA never granted the finding that Opana ER was abuse-deterrent because it didn't meet our standards.

SIEGEL: And I should just - just to state the obvious in case I'm getting the obvious wrong here, people who used to just crush these pills to abuse them then were confronted with a coating that made that much more difficult. But it seems they were going ahead, crushing, melting and shooting up with this substance. That's where the problem comes in. Do I have that right?

WOODCOCK: Yes. This - we're not saying that Opana ER, when it was taken as directed, would cause these problems. These problems were due to people who were injecting the drug.

SIEGEL: Your agency has asked Endo Pharmaceuticals to take Opana ER off the market. What does that actually mean? Is it an outright ban of the drug or not?

WOODCOCK: Well, FDA does not have the authority for drugs to immediately remove them from the market. Generally we ask companies to voluntarily pull their drug off the market. If they are not willing to do that, we will issue a notice of a hearing, and we have to go through a judicial type of process.

SIEGEL: What so far has been the response from the company?

WOODCOCK: Well, they're evaluating this request. So we did have an advisory committee meeting on this issue in March of this year, and the independent scientists voted 18 to 8 that the benefits of this drug no longer outweigh its risks.

SIEGEL: Dr. Woodcock, critics would say the FDA hasn't been tough enough on the drugs that are out there and that people are abusing. Does yesterday's action on Opana ER seem like perhaps a little too little too late?

WOODCOCK: The opioid crisis is a very serious problem, and we are exploring every avenue that we can to try to deal with this. This action has to do with a specific adverse event that is associated with abuse. The overall societal consequences of the abuse of these drugs is tremendous and terrible, and more definitely needs to be done. At the same time, of course the FDA - we have to keep pain medicines available, say, for people who have terminal cancer and so forth. So there's a balance that has to be kept there.

SIEGEL: Well, Dr. Woodcock, thank you very much for talking with us about it today.

WOODCOCK: You are most welcome.

SIEGEL: That's Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. Transcript provided by NPR, Copyright NPR.