Last month a US district judge ordered the FDA to make the morning-after pill available to females of any age without a prescription. This week the Justice Department announced that it would appeal the ruling.
The judge’s ruling was in response to a lawsuit launched by the Center for Reproductive Rights.
The group was seeking to expand access to all brands of the morning-after pill over the counter, such as Plan B One-Step and Next Choice, so that females of all ages would be able to purchase them without a prescription.
Supporters of the ruling called it a landmark decision, while opponents raised concerns about safeguards being eliminated.
“Safeguards” against teenage girls being able to say no to being pregnant.
Appearing before Planned Parenthood’s annual convention last Friday, President Obama pledged his continuing support for women’s reproductive rights. In a speech before the National Academy of Sciences on Monday, Mr. Obama promised to keep science a sphere “not subject to politics” or “skewed by an agenda.”
On Wednesday, his administration betrayed both reproductive rights and science. The Justice Department announced that it would appeal a federal court ruling that would make morning-after pills available without a prescription for girls and women of all ages.
In short he said one thing and did another.
In 2011, the secretary of health and human services, Kathleen Sebelius, overruled the Food and Drug Administration, which had decided, based on scientific evidence, that the pills would be safe and appropriate “for all females of child-bearing potential.” Ms. Sebelius arbitrarily determined that only women 17 and older should have access to the drug.
Then, last month, citing the political nature of Ms. Sebelius’s intervention and finding no “coherent justification” for it, Judge Edward Korman of United States District Court for the Eastern District of New York ordered the F.D.A. to make emergency contraceptives available over the counter to all women, with no age restrictions.
But no. We can’t have teenage girls saying no to pregnancy without someone’s permission – a doctor’s, their parents’, a priest’s – someone’s. The Times sums it up neatly.
Lack of access to safe contraception will not stop adolescents from having sex. Girls who have sex should not be punished with unintended pregnancies.
Uh huh. And Kathleen Sebelius wasn’t completely lying in an insultingly dumb way that required us to believe she’s not an educated woman when she claimed she “was concerned” girls wouldn’t know how to use it properly. And NPR was totally just reporting the facts when they repeated this with no qualifiers that would indicate the slightest editorial skepticism of the genuineness of that lie.
I think it’s this fear that has infected the Democratic party ever since maybe the McCarthy period – the fear of being seen as not as Normal Mainstream Real Folks Americans as everyone else. You don’t see girls of 13 taking the morning after pill in any Norman Rockwell illustration, so it must be a Wrong Thing.
They’ve had decades of being clobbered, co-opted, used, and continually punished by rightwingers. Just as you cannot take any action that the Vaculas of the world will not use to click the ratchet another notch, neither can “liberals” take any action meek or bold that will not result in them being neutralized.
The last time this issue came up (I think at Ed Brayton’s blog) I read the FDA Medical Officer’s report and the underlying studies from which he based his decision to recommend OTC status…and I have to say that I’m still not convinced that the safety of this drug has been proved in younger women. I know I’m the lone person urging caution here, so I’ll have my say and then get out of the way.
I raise my concerns because all of the studies — every one of them involving millions of uses — were in women older than age 18. And it’s just a fact that a 13-year-old is not the same as a 17-year-old.
I completely support reproductive rights for all women, regardless of age. But I’m still worried that we’re going to be conducting what amounts to a massive clinical trial in a vulnerable population.
It’s pretty clear the drug is safe in older women — in other words in the group for which the data are available. I have no problem with the FDA decision granting it OTC status in that population. It’s going to be a blockbuster for the company — billions of dollars in sales. Because it does what it’s supposed to do when taken correctly, with an acceptable safety profile.
And I understand completely that my conservative views on drug safety may be informed by other drugs we thought were safe but then turned out not to be. People who say that the FDA’s job is to decide on drug safety are correct, but naive. Vioxx was judged safe. Thalidomide was judged safe. DES was judged safe. And on and on and on. It wasn’t until we conducted the millions-of-doses experiment in the population did the real safety issues arise.
If it were my teen-aged daughter, I’d want a better option until after that millions-of-doses experiment. I do understand that this drug might the best choice against of a range of bad choices — or the only choice against zero other options.
Doesn’t mean that we should disregard the safety issue. All it would take would be one cancer signal — ovarian, etc., for the entire drug to be tossed into the shitter. And then everyone here would be screaming about how the FDA didn’t do its job. Frankly, if I were the company making this drug — I’d be at least as conservative about introducing it to younger women. But, the promise of big profits often overwhelms other issues.
I know this might be Solomon’s choice, but I’d be more in favor of a gradual introduction by age — 17 then 16. I don’t know if I’ll ever be fully content with safety data for women below that age — the 12- to 15-year-olds are the ones I suspect have the greatest risk of potential harm. But if we have solid data in 16-year-olds, then I’d be less twitchy about this. But “full speed ahead” seems to me to be reckless.
And I know this is an ancillary issue, but the younger the woman is, the more I’m concerned that this drug will be used incorrectly. It’s meant to be used the morning after unprotected intercourse. My concern is that the younger the woman, the more likely she is to “try” this when she’s missed her period. But by then, the drug would be ineffective. So in essence, she’s flushed $30 down the drain and still is pregnant.
You now are free to disagree with me and call me nasty names and impugn my motivations and whatever other silencing tactic you care to use. Not changing my mind.
Kevin – well that’s a reasoned argument.
Kevin argued this at Pharyngula at exceeding length. What he would not answer effectively is why:
a. The potential consequences of taking the drug are WORSE than an unwanted pregnancy, on balance
b. Why he is so particularly concerned about this but not the list of dozens and dozens of other OTC drugs with even worse potential side effect profiles.
It’s a warped set of priorities, even if he believes it comes from a place of caution and concern.
Yeah yeah. What is known about the safety of levonorgestrel in teenagers? Its use in oral contraceptives, implants, and the Mirena IUD, among others. It’s not some new mystery drug nor is it being used for a significantly different purpose when taken a single time instead of daily for months or years.
incidentally, IUDs (hormonal or copper) can also work as emergency contraception. They aren’t nearly as well-known as they should be, IMHO.
I think it’s this fear that has infected the Democratic party ever since maybe the McCarthy period – the fear of being seen as not as Normal Mainstream Real Folks Americans as everyone else.
Yeah. I think the Democrats have been running away from the echoes of Adlai Stevenson and George McGovern. Because they don’t want to be characterized as eggheads or wimps or soft on communism.
I’m not an expert on this topic, but nor am I completely ignorant. My skepticism senses that, first, you may be overestimating these differences. Second, I would suspect, as Josh eludes, that there are many drugs that aren’t thoroughly tested on teenagers. My educated guess would be that teenagers perhaps cannot be used for testing purposes because they cannot legally consent to such tests.
Actually, Thalidomide never received FDA approval. It was approved by some other regulatory authorities in some other countries, but saying that it was “judged safe” in a paragraph discussing the FDA is lying by elision.
Quelle Suprise! No one could have anticipated!
IOW, he’s done that so often I’ve completely lost count.
I second Opehlia: don’t say you’re for my reproductive (or any other) rights when you’re clearly not. Just stop lying already.
Kevin is concerned.
And therefore we must force 13-year-olds to become parents.
I’m going out on a limb here, but you might just find an actual adult able to show your daughter how to use a condom. Somewhere.
Feline, a morning after pill is intended to fix up a situation where a neither a condom nor anything else, for whatever reason, has not been used.
There are a number of ways unwanted pregnancies can be approached. One is to give the newly pregnant woman the option of an abortion of whatever kind, (and the earlier the better). Another is to give her the option of allowing the pregnancy to proceed to term, with whatever financial support from the state is required along the way.
But Kevin’s concern about the differing effects of drugs at different stages of life is a valid one, from what I have gathered.
Well that sentiment is not going to win much approval from the conservative crowd. Unintended pregnancy is God’s way of telling us who the sluts are, so we know who to stone. Modern civilization won’t let us stone them any more, but we sure have to punish them somehow.
Yes, which is why it’s also know as emergency contraception. This isn’t news.
And I have no idea why someone would think that it would be better to ensure that a zygote had implanted before solving the problem.
If we were unaware of the effects of teenagers having babies, sure.
But generally a short sharp chock of hormonal pills is preferable to nine months of pregnancy if we are only looking at the effect on the body. Because pregnancy isn’t nothing, you see. It’s a bit of the old “The pill will double the risk of a blood clot!”, which is true, but since pregnancy will increase that risk ten-fold it might be a risk women are willing to take.
No, it isn’t. Some 17 year old girls have not had menarche, some have. The same is true for 13 year olds. We don’t all wake up at 14 and a half, have our period and celebrate with a cupcake. If a 13 year old is sexually active she should have access to this drug, there is no reason to think it would have any greater side effects in her than in someone older. Why? Because once a woman starts ovulating, her uterus “works” on the same principles as every other woman’s does until menopause, when it stops “working”.
I doubt anybody studied the effects of latex condoms, aspartame, nail polish, sugar-free gum, or cellphones on teenage biology to the extent that people expect these pills to be studied. This is because in most ways, teen physiology is not sufficiently different from adult physiology to warrant a study. There are exceptions, of course, but ovaries aren’t one of them.
I have to say that I’m still not convinced that the safety of this drug has been proved in younger women. I know I’m the lone person urging caution here…. And it’s just a fact that a 13-year-old is not the same as a 17-year-old.
You’re unable to properly asses levonorgestrel’s (LNG) safety in this patient population because you’re not familiar with a basic fact. When it comes to LNG ECPs a 13-year-old is, in fact, the same as a 17-year-old.
A menstruating kid (11 yo, 12 yo, etc) is biologically an adult as far as ovarian function is concerned. That’s why you can extrapolate study results in this patient population for LNG ECPsl.
“…But generally a short sharp chock of hormonal pills is preferable to nine months of pregnancy if we are only looking at the effect on the body. Because pregnancy isn’t nothing, you see. It’s a bit of the old ‘The pill will double the risk of a blood clot!’, which is true, but since pregnancy will increase that risk ten-fold it might be a risk women are willing to take.”
.
Be that as it may, Feline. I was putting a case for maximising a (whatever age) woman’s range of choices on the morning after. You seem to be more intent on putting a case for one of those possible choices.
None the less, I don’t think we are on opposite sides on this issue.
.
“Because pregnancy isn’t nothing, you see.”
You surprise me there. I always supposed it was. 😉
Here’s a short and complete answer to Kevin:
Plan B is safer than a bottle of aspirin or acetaminophen, either of which can kill you.