Hear from the FDA commissioner who approved the abortion pill
OWhen former US Food and Drug Administration (FDA) Commissioner Dr. Jane Henney approved the abortion pill mifepristone in 2000, she knew the decision was important for women’s health. It would also become incredibly controversial.
Henney, now 76, still finds herself defending that endorsement more than two decades later in 2023. She spoke to TIME on April 12 about the unprecedented situation Justice decision withdrawing FDA approval of mifepristone and what it means for the future of the agency she once led. (This interview has been condensed and edited for clarity.)
TIME: You were the first female commissioner of the FDA, from 1998 to 2001.
And the first commissioner to suspend drug approval. Lots of firsts; I don’t know what that looks like on a CV.
How important was mifepristone to you when it was approved, given its potential impact on women’s reproductive health?
I knew it was important. It was a first-class drug, so if approved, it would be the only anti-abortion drug on the market.
Since this was the first drug of its kind to induce abortion, were there any special procedures followed by the FDA during its review?
I knew it was important that we do this review in an impeccable and thorough manner and in a way that we can all support with confidence. I told the reviewers as they went about their work, “You do it in the normal way, thorough and thorough, and when you come to your conclusion, whether it’s a recommendation for approval or a recommendation of non-approval, or if you need more information to make your recommendation, you will have my support. The review process followed exactly the usual way of reviewing new drugs.
Learn more: What the new restrictions on abortion pills mean and what comes next
I still think the approval decision was correct. And I’m proud of it that way. We didn’t let the political climate or political issues around abortion influence what the agency did.
What was the political climate at the time the drug was awaiting approval, and how does it compare to the highly contentious nature of abortion discussions today?
At that time, Roe v. Wade had been considered legal for almost 30 years. It wasn’t like there was no more tension around the issue of abortion…but we weren’t dealing with a climate where abortion was legal in some [states] but not in others. In this sense, the situation has changed.
Issues like abortion are so politically charged that a drug affecting the termination of pregnancy will inevitably be caught up in this conflict. Was there pressure from parties with opposing political interests that supported and opposed drugs?
Some call it political pressure, others call it political self-interest, and it’s probably more accentuated with a drug like mifepristone. These decisions made by the FDA affect real people, which is why the agency takes its role so seriously and why it brings together the best minds with all kinds of expertise, from clinical issues to scientists to manufacturing and quality.
Learn more: What Happens Next in the Fight Against Abortion Pills
But they do not use political measures to arrive at their conclusions. They have truly been entrusted, and expected, by law [power] make such decisions. They are very proud—and I think they should be—of the fact that they have been and are the gold standard in the drug approval process.
How concerning is the fact that a judge can overrule the FDA approval of a drug?
Congress has clearly signaled and given authority to the FDA in this area because it is convinced that the agency uses the kinds of scientific and disciplinary expertise to make very many decisions regarding the approval of any drug in its review process. This both undermines the authority of the FDA if this decision stands and makes it possible that it could happen to any other drug.
Learn more: How the Abortion Pill Ruling Could Limit FDA Authority
But it also goes a bit to the heart of the FDA’s given and expected authority in terms of final drug decision-making power. Is it open to question? We would then have an environment in which everything could be questioned. This would terribly disrupt the market and people’s confidence in the products they consume.
Does the judge’s decision to suspend the approval of mifepristone undermine the authority of the FDA?
This is, in my opinion, one of the most dangerous elements of this whole discussion at the moment. This can jeopardize this whole approval process. The direct conversations are now about mifepristone, but the bigger conversation is really about credibility and authority — and the expectation of the public, through its legislature, that the FDA will do the job it is asked to do.
If you were the head of the FDA now, how would you react to this decision and how would you try to assert the agency’s authority over drug approvals?
It’s a very difficult question. I think everyone I know who has served as commissioner, whether under a Republican or Democratic administration, was there because they are trying to do their best for public health. But they must do so within the limits of the law. Sometimes your personal feelings conflict with some of these things, but you must do what is expected of you within the bounds of the law. How that’s going to play out – I think we’re all waiting to see. It’s a very difficult harness to occupy at the moment.
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