Is the Plan B battle over? Former FDA official Susan Wood hopes so.

April 6, 2013
Assistant FDA Commissioner Susan F. Wood cited interference in decision making at the agency in her resignation. (Lucian Perkins/ The Washington Post)

Susan Wood resigned as director of the Food and Drug Administration's Office of Women's Health in 2005, when the George W. Bush administration chose to delay indefinitely a decision on whether emergency contraceptives should be sold over the counter. She is now an associate professor of health policy at George Washington University and still follows the debate over the morning-after pill closely.

Wood and I spoke Friday about the judge's ruling, what it means for Plan B, and whether a decade-long battle over emergency contraceptives might finally be coming to an end. A transcript of our conversation follows, lightly edited for clarity and length.

Sarah Kliff: You've obviously been involved in this debate over emergency contraceptives for quite some time. What does the ruling, that the FDA must lift its ban on over-the-counter Plan B for women 16 and under, mean?

Susan Wood: It’s a real win for women to have all access to emergency contraception. It’s not just younger teens we're talking about, it's the older women who still have to find an open pharmacy and have to stand in multiple lines.

It's also a big win for the FDA. The ruling was supported by science and also [by FDA Commissioner Margaret Hamburg]. I think it's also an opportunity, all the way up to the administration, to do a reset with the FDA and say: That was a problem, we’re not going to do that anymore. We’re going to move on and go back to the way the FDA does business, keeping a focus on a separation between political controversy and the safe and effective medicine the FDA is trying to oversee. I'm hoping that's what happens.

SK: I wanted to ask you about the politics of this, because when I think back to when Secretary Sebelius initially overruled the FDA on this, it was right around the time that the administration was deciding on whether the health-care law would require all employers to cover contraceptives without co-pay. And even though those were two separate issues, they both touched on the politics of contraceptives and reproductive health.

I wonder, now that it's past the election and the administration has decided on contraceptives, whether the politics of this issue are different.

SW: It was the context of all of those decisions back then. In looking back over the last year and a half, when the last round of decisions was made, unfortunately mistakes were made.

Now, I think, we’re in a place where hopefully even folks in the political realm appreciate the fact that contraception is something that women and men support and don’t see as controversial. There are small elements that do, but that this is a subject that women care about because it affects their health, lives, opportunities, families and kids. All of this is really important to people.

The timing conflated the the two decisions in January last year, and then there was a backlash from the Catholic hierarchy, and then that got a backlash from the American people. I think that did open people's eyes that standing firm for contraception is a winning issue. You have to stand firm both because it's a winning issue and because it's right.

SK: You resigned over a delay on approving Plan B for over-the-counter sale in 2005. Did you expect that we'd be fighting this battle eight years later?

SW: I have been constantly surprised, but maybe that says more about me than the issue. I was completely surprised before I resigned that the decision to block it at that time was going to made. I knew how strong the data was, the process had been going on, and [thought] there’d be no way that it would be stopped. So then I resigned. Then a year later, almost exactly, when there was partial approval, I was flabbergasted. I was convinced no way would the administration do that.

I figured when the administration changed in 2009, and we had a court ruling that said go back and re-do it, it was just sat on. I did not expect it to take that long. Then a year and a half ago, I was waiting on the December decision and convinced that it was going to be it. Once again I was floored. This was a new administration now.

SK: Do you think this decision will stand? Or do you expect the Obama administration to appeal it?

SW: Now I’m crossing my fingers and being really hopeful, I do have a sense of remaining concern that we’re not going to be able to pull it off. I’m feeling hopeful today. Hopefully the administration will see that now is the time to move forward, not back.

SK: You mentioned earlier that this won't improve access just for young teens, but also for women over 17. How much of a hurdle is it now for an older woman to access Plan B?

SW: It’s going to affect many more women over the age of 17. I had this experience when the last decision came down, and I was going to be talking to reporters. I thought I better buy some Plan B, so I can get a look at the current warning labels.

On a Saturday evening, around 6:30 p.m., I went to my local CVS and the pharmacy was closed down. So I got back into my car, drove a few miles away to a place I knew had an all-night pharmacy. I'm thinking: This'll be the place. But they're closed. So I asked where is the closest all-night pharmacy and they tell me one that's a few miles away.

I get in line for the pharmacy, I ask for Plan B, and I have to stand in a second line. I stand in the second line and I get to the front, and I have to point out, yes, that's mine over there. How embarrassing is that if you're 25? Then they asked for my ID. I have white hair. I said you've got to be joking, and the pharmacist says she has to enter in my birth date.

To get this product I had to travel to three pharmacies, embarrass myself, get carded, and meanwhile at all three places I didn't need the pharmacy to be open to buy condoms, spermicide or a pregnancy test.

SK: One part about the ruling that interested me was that it allows the FDA to change the warning labels on Plan B if they think they aren't clear enough for young women to understand. Do you think the agency will do that?

SW: With many over-the-counter medications, if you truly have a concern, you could put a label on it that said not for use for those under the age of 12 or not for use for a female under a certain age. Those types of labels are on all kinds of over-the-counter products. If the scientific reviewers at the FDA feel it's relevant, they'll add it.

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