When former U.S. Food and Drug Administration (FDA) commissioner Dr. Jane Henney approved the abortion pill mifepristone in 2000, she knew the decision was an important one for women’s health. It would also become incredibly contentious.
Henney, now 76, finds herself still defending that approval more than two decades later in 2023. She talked to TIME on Apr. 12 about the unprecedented legal decision to strip mifepristone of its FDA approval, 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 have a drug approval suspended. A lot of firsts; I’m not sure how that looks on a resume.
How important was mifepristone to you when it came up for approval, given how it could impact women’s reproductive health?
I knew it was important. It came in as a first-in-class drug, so if approved would be the only anti-abortion drug on the market.
Because it was the first drug of its kind to induce abortion, were there any special procedures the FDA followed during its review?
I knew it was important that we do this review in a pristine and thorough way and in a way that we could all stand confidently behind. I told the reviewers as they were going about their work, “You do this in a normal fashion, thoroughly and completely, and when you arrive at your conclusion—whether it’s an approval recommendation or a non-approval recommendation, or whether you need more information to make your recommendation—you’ll have my support.” The review process followed to the letter the normal way we reviewed new drugs.
I still feel the decision around approval was correct. And I am proud of it in that way. We did not let the political climate or political issues around abortion influence what the agency did.
What was the political climate like at the time the drug was up for approval, and how does it compare to the highly contentious nature of abortion discussions today?
At that point, Roe v. Wade had been seen as lawful for nearly 30 years. It wasn’t like there wasn’t still tension around the issue of abortion…but we weren’t dealing with a climate where abortion was lawful in some [states] but not in others. In that sense, the situation has changed.
Issues like abortion are so politically charged that a drug affecting termination of pregnancy will inevitably get caught up in that conflict. Was there pressure from parties with conflicting political interests who supported and opposed the drug?
Some call it political pressure, other people call it political interest, and it’s probably more heightened with a drug like mifepristone. These decisions the FDA is making affect real people, which is why the agency takes its role so seriously, and why it brings the best minds to the table with all kinds of expertise, from clinical to scientific to manufacturing and quality concerns.
But they don’t use political measures in coming to their conclusions. They really have been entrusted, and expected, by statutory [power] to make such decisions. They hold that with great pride—and I think they should—the fact that they have been and are the gold standard for this drug approval process.
How concerning is the fact that a judge can overturn a drug approval by the FDA?
Congress clearly signaled and has given FDA authority in this area because it has felt confident that the agency employs the kinds of scientific and disciplinary expertise to make many, many decisions around the approval of any drug in its review process. It both undermines the authority of the FDA if this decision stands, and makes it possible that this could happen to any other drug.
But it also goes a bit to the heart of the authority given and expected of the FDA in terms of its final decision-making authority with respect to drugs. Is it open to question? Then we would have an environment in which anything could be questioned. That would be terrifically disruptive to the marketplace and to the kind of confidence people can have in the products they take.
Does the judge’s ruling to suspend approval of mifepristone undermine the FDA’s authority?
That is, in my view, one of more dangerous elements of this whole discussion right now. It can call into question all of this approval process. The direct conversations now are about mifepristone, but the bigger conversation is really about the credibility and authority—and the expectation by the public, through their legislature, that FDA will do the job it’s required to do.
If you were leading the FDA now, how would you respond to this ruling, and how would you try to affirm the agency’s authority over drug approval?
It is a very hard question. I think everybody I know who has sat in the commissioner’s role, be it during a Republican or Democratic administration, was there because they are trying to do the best job they can for public health. But they have to do that within the constraints of the law. Sometimes your personal feelings come into conflict with some of those things, but you must do what you’re expected to do within the constraints of the law. How this is going play out—I think we are all waiting to see. It’s a very tough hot seat to be in right now.
View original article
Contributor: Alice Park