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Former FDA commissioner defends original approval of mifepristone

JUANA SUMMERS, HOST:

In late September 2000, about a month before the presidential election, the federal government approved the use of a little white pill for some abortions.

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UNIDENTIFIED PERSON: The Food and Drug Administration's approval yesterday of the abortion pill RU486 is already becoming an issue in the presidential race. People on both sides...

SUMMERS: RU486, also known as mifepristone - medically speaking, it had already been used in Europe for more than a decade, but, politically, it was controversial in the States. In the final days of his White House campaign, Republican nominee George W. Bush denounced the drug's approval but said he couldn't do much about it.

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GEORGE W BUSH: I think once the decision's made, it's been made - now, unless it's proven to be unsafe to women.

SUMMERS: And the FDA decided, with some restrictions, that it was safe for abortion.

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JANE HENNEY: A woman doesn't have to undergo a surgical procedure, with the complications of a surgical procedure that could arise, or having to have anesthesia.

SUMMERS: That's Jane Henney, who was FDA commissioner at the time and the first woman to serve in that role. Years later, as further studies supported the drug's safety, Henney went on to push for even broader access to it. But last week, a federal judge in Texas suspended the FDA's approval, and now, access to mifepristone is in legal limbo.

Dr. Jane Henney joins me now. Welcome.

HENNEY: Thank you very much, Juana. Very nice to be with you today.

SUMMERS: So when this drug was first submitted for approval, paint a picture of what mifepristone meant for patients who were seeking abortions.

HENNEY: Well, mifepristone was really the first submission for the early termination of pregnancy. Prior to that, most abortions were surgical abortions. It had existed in other parts of the world - in France, where mifepristone was originally studied, and then in Europe. But in the U.S., medication abortions really didn't exist; at least there were no approved drugs for that purpose.

SUMMERS: The anti-abortion groups who filed the lawsuit that's currently in the news, they say that the FDA used an improper process in approving mifepristone. They've argued that the approval was rushed through an accelerated process, that this pill didn't qualify for a fast track because pregnancy's not an illness. And they say the FDA didn't do enough to look into mifepristone's safety in patients under the age of 18. You were leading the FDA at the time, and I'm curious what you make of those arguments.

HENNEY: Well, I can assure you that mifepristone was handled in a very proper way. It was given a very thorough review. It was not rushed. The approval process, in terms of looking at all of the scientific data, all of the clinical data, the data around how this drug was manufactured followed the normal process of how the FDA reviews every product that it has.

SUMMERS: Given where public opinion is on the issue of abortion now, 20-plus years removed from that approval, does anything about the conversation that we are having now around this drug surprise you now?

HENNEY: It doesn't surprise me. It disappoints me that we don't see women's health and women's health needs in a broader and more accepting light. That's the disappointment. But I think just considering a number of things that are going in - on in our world that has us at conflict with each other, it's not surprising.

SUMMERS: On a personal level, what is it like for you to see mifepristone, this drug that you worked to approve, facing such jeopardy today?

HENNEY: Again, it's disappointing not for me personally, but for women who are kind of facing the very chaotic message in terms of the availability of this drug. It's used now in over 50% of abortions. Five million women have been treated. It's been extensively studied since the time of approval with probably over a hundred studies. So the message to women in terms of something that they may need being available, I think, is a very mixed and a very difficult one to accept. And in that way, I think that it is a hard message to come to grips with. I also think there's a message there for, you know, the other approvals that FDA deals with every single day.

SUMMERS: I want to follow up on that because yesterday you told reporters that this ruling, quote, "sets a very dangerous precedent for the FDA's authority in terms of other new medications." Can you be a little more specific? I'm curious, what impacts do you think this could foretell that could possibly happen to new medications?

HENNEY: I don't have a crystal ball on this, Juana, but if courts or others start calling into question the authority of the agency to signal that products are safe and effective and can move to market, if that is disrupted, it really causes chaos not just in the marketplace, but chaos for medical providers and patients who need a sound and solid voice of authority to say this has been reviewed; these products are safe and effective; we are making data available to you about known side effects. And having that in place has really been the gold standard not only for this country but the world in many cases.

SUMMERS: Thinking back, I'm curious, is there anything about the approval process that, in retrospect, you think the FDA could have done differently under your watch to avoid the kind of legal challenge that's now putting access to mifepristone in jeopardy?

HENNEY: I really do not believe that to be the case because I do believe that we followed the normal procedure. We had the best lines working on this product. The agency has monitored this drug over the past 20 years. So I am very comfortable and confident that that decision was right and that many people have benefited from that decision and believe that it should stand.

SUMMERS: Former FDA commissioner Jane Henney. Thanks again for talking to us today.

HENNEY: Oh, I really appreciated the opportunity. Thank you. Transcript provided by NPR, Copyright NPR.

Ashley Brown is a senior editor for All Things Considered.
Juana Summers is a political correspondent for NPR covering race, justice and politics. She has covered politics since 2010 for publications including Politico, CNN and The Associated Press. She got her start in public radio at KBIA in Columbia, Mo., and also previously covered Congress for NPR.