JEFFREY BROWN: The secretary of health and human services has waded into the politically charged issue of birth control for younger girls.
In a very public and high-level disagreement, Kathleen Sebelius today blocked the Food and Drug Administration from allowing girls under 17 to buy the Plan B morning-after pill without a prescription.
For the details, we’re joined by Rob Stein, covering the issue for The Washington Post.
Rob, so fill in what’s happened here. This is the HHS secretary overruling her own FDA.
ROB STEIN, The Washington Post: Right. This was a big surprise, a real shock. Nobody knew what the FDA was going to do, but nobody expected the secretary for health and human services to overturn the decision by the FDA.
What happened was, the FDA commissioner, Margaret Hamburg, reviewed the evidence and decided, yes, it was OK to approve this company’s request to sell Plan B basically on any stores, in grocery stores, drugstores, right next to condoms or spermicides. But Secretary Sebelius stepped in and said, no, I just don’t agree that decision.
JEFFREY BROWN: Now, just remind us the state of play here. Plan B has already been approved for use without prescription by women over 17, right? So what was this about?
ROB STEIN: Right.
Right now, the way it works is that if any women — any woman who’s 17 years old or older can walk into a pharmacy and buy Plan B without a prescription, but they have to prove that — their age to the pharmacist. But anybody younger than that still has to get a prescription.
And women’s health advocates, family planning advocates had hoped to make it easer get, so that any women of any age could go in and get it without a prescription. It would make it a lot easier to prevent unwanted pregnancies.
JEFFREY BROWN: And, as a practical matter, that means it’s not sold just out there on the shelves. It’s behind the counter.
ROB STEIN: Right.
And what often happens is, you will have a situation where, you know, a woman has unprotected sex or has a problem with a condom, or maybe is even a rape victim in the middle of the night or on the weekend, and there’s sort of a panic about what to do about it. And with this drug, it’s very important that you take it within the first 72 hours. That’s the period of time in which it’s most effective.
JEFFREY BROWN: So, what was the reasoning by Secretary Sebelius in blocking the change?
ROB STEIN: You know, she basically said that she just didn’t feel that there was enough conclusive evidence to show that it could be used safely by girls of any age.
And she specifically cited that girls as young as 11 years old can get pregnant, and she just didn’t feel comfortable that there was enough evidence that young girls, girls 11, 12 years old, really could handle this on their own.
JEFFREY BROWN: Now, this is of course a highly charged political and cultural issue. What kind of — what kind of pressures were being brought to bear on all health officials in this case?
ROB STEIN: Yes. There was a lot of opposition to make — to relaxing the restrictions on Plan B.
A lot of conservative activist groups, the U.S. Conference of Catholic Bishops, and a lot of groups like that were very much opposed to it. They said that they thought that it was unsafe and that young girls and women could not use it safely. They were worried about it encouraging sexual activity. They were worried that, by skipping a doctor’s visit, that girls who had STDs wouldn’t be picked up. So there were a lot of concerns on the other side.
JEFFREY BROWN: And then when the decision came out today, plenty of reaction from supporters of it, including, I saw, former FDA official Susan Wood suggesting that politics had overruled science here.
ROB STEIN: Right.
The proponents of easing the restrictions are irate. They’re really surprised and really upset, because they thought that this was — this administration was kind of an administration that wouldn’t let politics get in the way of a scientific decision.
You mentioned Susan Wood. She resigned from the FDA under the Bush administration, because that administration had delayed a similar easing of restrictions. And so people are very upset on that side.
JEFFREY BROWN: And, briefly, Rob, is there any next step here beyond the political repercussions? Is there more to come on the health side or on a policy side?
ROB STEIN: Well, there’s still a lawsuit pending against the FDA.
One of the activist groups filed a lawsuit many years ago because of the delays in easing the restrictions. And there’s actually a hearing scheduled for Dec. 13 on a contempt of court motion against the FDA for failing to ease the restrictions. So, it will be interesting to see what happens there. The judge in that case had been very critical about the idea that politics might be interfering with a scientific decision.
JEFFREY BROWN: All right, Rob Stein of The Washington Post, thanks very much.
ROB STEIN: Thanks for having me.