Coathanger lobby update: the Obama Administration.

coathangerLoyal Reader™ Sunshine forwarded to the Palace a missive from FDA Commissioner Margaret Hamburg, M.D. regarding Plan B One-Step, the so-called “morning after pill.”  Dr. Hamburg’s statement is reprinted below in its entirety:

The U.S. Food and Drug Administration (FDA) has been carefully evaluating for over a decade whether emergency contraceptives containing levonorgestrel, such as Plan B One-Step, are safe and effective for nonprescription use to reduce the chance of pregnancy after unprotected sexual intercourse.

Plan B One-Step is a single-dose pill (1.5 mg levonorgestrel tablet) which is effective in decreasing the chance of pregnancy if taken within 3 days after unprotected sexual intercourse.  The product contains higher levels of a hormone found in some types of daily use oral hormonal contraceptive pills and works in a similar way to birth control pills.

Plan B One-Step was originally approved in July 2009 for use without a prescription for females age 17 and older and as a prescription-only option for females younger than age 17.  In February 2011, Teva Women’s Health Inc. submitted a supplemental application seeking to remove the prescription-only status for females younger than age 17 and to make Plan B One-Step nonprescription for all females of child-bearing potential.

The Center for Drug Evaluation and Research (CDER) completed its review of the Plan B One-Step application and laid out its scientific determination. CDER carefully considered whether younger females were able to understand how to use Plan B One-Step.  Based on the information submitted to the agency, CDER determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.

It is our responsibility at FDA to approve drugs that are safe and effective for their intended use based on the scientific evidence.  The review process used by CDER to analyze the data applied a risk/benefit assessment consistent with its standard drug review process.  Our decision-making reflects a body of scientific findings, input from external scientific advisory committees, and data contained in the application that included studies designed specifically to address the regulatory standards for nonprescription drugs.  CDER experts, including obstetrician/gynecologists and pediatricians, reviewed the totality of the data and agreed that it met the regulatory standard for a nonprescription drug and that Plan B One-Step should be approved for all females of child-bearing potential.

I reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER, and I agree with the Center that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.

However, this morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential.   Because of her disagreement with FDA’s determination, the Secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved.  Following Secretary Sebelius’s direction, FDA sent the complete response letter to Teva today.  Plan B One-Step will remain on the market and will remain available for all ages, but a prescription will continue to be required for females under the age of 17.

The first thing that leapt to my mind upon reading this was, Gee, I am sure Secretary Sebelius must have a very compelling reason for overruling the decision of her own agency — the first time in history that the Department of Health and Human Services has ever done so.  (Actually no, that was not my first thought.  It wasn’t even my second, third or fourth thought, either.  But it was an eventual thought nonetheless.)

It turns out that Kathleen Sebelius issued a statement and separate letter to Dr. Hamburg, which you can read in its entirety here (pdf). The Washington Post summarized her position this way:

Sebelius said she reversed the FDA’s decision because she had concluded that data submitted by the drug’s maker did not “conclusively establish” that Plan B could be used safely by the youngest girls.

To which I can only retort:  hey Secretary Sebelius, do you know what cannot be used safely by the youngest girls?  The birthing process.  However, young girls need neither a prescription nor parental consent for that.

The Palace is hereby issuing its thoughtfully considered statement on this matter:

IF A YOUNG GIRL HAS THE GOOD SENSE TO SEEK OUT
EMERGENCY CONTRACEPTION WHEN SHE NEEDS IT,
WE SHOULD FUCKING GIVE IT TO HER.
(FOR FREE.)

I cannot wait for the Obama fanbois and apologists to spin this one.  I have my own theory, though:

obamarepublican

7 thoughts on “Coathanger lobby update: the Obama Administration.

  1. Good morning, Mr. Born.

    Thanks for the link. From the editorial:

    Kathleen Sebelius, the secretary of health and human services, reversed the decision, arguing that younger girls, those 11 or 12 years old, have different cognitive and behavioral skills than older girls.

    It is such a ridiculous argument, I still cannot get over the fact that she made it. So…if 11 or 12 year old girls have different cognitive and behavioral skills than older girls, do these different skills make 11 and 12 year olds better able to handle an actual pregnancy, as opposed to taking the responsible step to prevent one? Or how about an abortion? Hope they don’t live in one of those backwards-assed parental consent states, or a state with one clinic in a single city far from where they live.

    If this argument came from a wingnut, sure. They don’t know or even care if what they say is true, as long as it suits their ideology. But Sebelius? She cannot possibly really believe what she’s saying, which makes this a cold political calculus at the expense of desperate — and responsible — young girls.

  2. This issue seems like a distraction to me. How can you deem them responsible if they’re having unprotected sex? The reason why they’d need the pill is because there weren’t responsible. They can still get the pill just not over the counter. Iris, are you planning to vote in 2012? If so, I don’t see how you vote for anyone OTHER than Obama. If for no other reason than Supreme Court Justice appointments. Seriously, do you want one of those GOP nutjobs to win and be the one to appoint two more SCOTUS justices? You think you’re writing alot of coathanger lobby blog entries now? You ain’t seen nothin’ yet. They’ll be doing everything in their power to overturn Roe V. Wade, pass personhood amendments, Defense of Marriage, Don’t Ask Don’t Tell…it would be a fucking nightmare. That being said, I have a list of issues with Obama but I have a longer list of things he’s accomplished. Despite his shortcomings, he’s still a far cry better than the circus clowns on the right and so I consider him the lesser of two evils. Hopefully down the road the 99% movement can force the type of change that will no longer make us have to choose between the lesser of two evils but instead have to choose between the greater of two goods.

  3. @Truthteller

    This issue seems like a distraction to me.

    To a Penis American who will never have to face the consequences of an unwanted pregnancy, I can understand why it might be a “distraction” — to you. To a Vagina American who has fought on the front lines of reproductive rights for most of my adult life, it is anything but distraction. But hey, since you put it that way, I think I’ll stop encouraging and reminding the men in my life to seek regular prostate and testicular cancer screenings. (And it should go without saying that the government shouldn’t spend a dime on it.) Other people’s basic health care is just such … what’s the word? Oh yeah: a distraction.

    How can you deem them responsible if they’re having unprotected sex? The reason why they’d need the pill is because there weren’t responsible.

    This is unbelievably wrong-headed on so many levels, I’m genuinely surprised it is coming from you. First, you know they’re having unprotected sex how, exactly? (Newsflash: Condoms fail. Also: shit happens.) Second, you know they have not been sexually assaulted, how? Because guess what? It turns out that this is actually a horrifyingly common occurrence in the U.S. (pdf.) Third, adult women, being imperfect humans, make use of the Plan B pill for those same reasons, and in addition, they make use of it because they had unprotected sex (whether accidentally or irresponsibly). Plan B is remarkably safe and effective, and there is no argument for blocking teens from getting it over the counter that cannot also be applied to adult women. I’m pretty sure you don’t want to go there — do you? Fourth, even if they were not responsible in the way you imply, i.e., they made a poor decision (teens! Go figure…) and had unprotected sex, what in your opinion would be a responsible course of action to take the next day? Start raising the money for an abortion?

    So yeah: I am deeming “responsible” anyone, including any young teenager, who finds herself at risk of an unwanted pregnancy — for whatever reason — and who then immediately takes the quickest, safest, least invasive, least consequential, least expensive action she can to prevent pregnancy.

    They can still get the pill just not over the counter.

    I see. So a fourteen year old who needs Plan B (which must be taken within 72 hours of intercourse, and is more effective the sooner it is taken) can simply obtain a prescription for it! What could be simpler? Especially over a weekend. And there are no such things as conscience clauses that her doctor or pharmacist could invoke to deny her access to Plan B. If it were available over the counter, the Forced Birth Brigades, Medical Contingent, would be out of luck, and out of young peoples’ vaginas. That would be a very good thing.

    Iris, are you planning to vote in 2012?

    Of course. But as we’ve learned, voting is not enough.

    If so, I don’t see how you vote for anyone OTHER than Obama. If for no other reason than Supreme Court Justice appointments.

    Although a lot could happen in a year, I think it’s a pretty safe bet that (a) Obama will be the Democratic nominee, and (b) I will hold my nose, suppress my gag reflex and vote for him, just like I did in 2008, and for precisely the reason you give: Supreme Court (and other federal judicial) appointments. In the meantime, I will exercise my right — sorry, my duty — and do everything in my power to pressure and push him and his party to the left, toward reality, toward sanity — and to call him out clearly and directly when he does stupid, harmful, deadly, destructive, conservative shit. Like this unconscionable Plan B bullshit.

    Seriously, do you want one of those GOP nutjobs to win and be the one to appoint two more SCOTUS justices?

    Of course not. You said “Seriously.” Are you actually serious? ‘Cuz, wow.

    You think you’re writing alot of coathanger lobby blog entries now? You ain’t seen nothin’ yet. They’ll be doing everything in their power to overturn Roe V. Wade, pass personhood amendments, Defense of Marriage, Don’t Ask Don’t Tell…it would be a fucking nightmare.

    Yes, that is all true. And if you read this blog regularly, you know that I am all too well aware of these things, and hardly need it spelled out to me in my own comments section.

    That being said, I have a list of issues with Obama but I have a longer list of things he’s accomplished.

    That’s funny: my list of issues with Obama is longer than my list of things he’s accomplished. A lot longer, actually.

    Despite his shortcomings, he’s still a far cry better than the circus clowns on the right and so I consider him the lesser of two evils.

    He is on the right, albeit not nearly as far as the circus clowns you mention. That is what makes him the lesser of two evils: conservatism in the 21st century United States is evil, in theory and in practice. On national defense (that reminds me — just as an aside, we should totally rename the Defense Department the Offense Department, at least until it focuses on, you know, defense), war on “terror,” unconstitutional National Security State programs, corporate whoring, state secrets, economic policy, faith-based initiatives, the rule of law, Executive authority, Israel, indefinite detention, etc., and now, access to safe and effective contraception for young women, Obama is conservative. This is just a fact.

    Hopefully down the road the 99% movement can force the type of change that will no longer make us have to choose between the lesser of two evils but instead have to choose between the greater of two goods.

    That is my hope, too. But that road you speak of? It doesn’t appear out of nowhere. Nor does it pave itself.

    On a broader note, I’m just not clear what your beef is with this post. If you would prefer that I refrain from criticizing Democratic politicians in general and/or Obama in particular when they act like depraved conservative assholes because the hard right wingnuts are manifestly worse, or that I am somehow hindering Obama’s reelection by doing so, then boy are you at the wrong blog.

    If that is not your view, I would very much welcome clarification.

  4. Also, from a just-released CDC study:

    Most female victims of completed rape (79.6%) experienced their first rape before the age of 25; 42.2% experienced their first completed rape before the age of 18 years.

    How irresponsible of them.

  5. As I knew you would, you got entirely too worked up about my response. It was not meant to champion the decision about the morning after pill it was meant to put things into perspective instead of being hypersensitive to one small part of an issue. The vast majority of women can still easily obtain the Plan B pill and I believe that it needs to be available. I don’t have children but if I had a young daughter who needed the Plan B pill I would want to know about it. That’s just me. I understand that my thoughts on the subject don’t fit every situation. As for Obama, I agree with you. I’ll be holding my nose as well but try visiting: http://whatthefuckhasobamadonesofar.com to see a list of accomplishments. Many people seem to harp so heavily on his faults that they forget to remember his accomplishments. I’m just trying to keep things real. Sorry if you took it the wrong way. You know I have nothing but respect for women and their reproductive rights. Settle down there terminator!

  6. Hello again my friend.

    I find it…interesting that you failed to address a single point raised in my rebuttal to you, or in the OP for that matter. For starters, FDA Commissioner Margaret Hamburg, M.D., concluded that “there is adequate and reasonable, well-supported, and science-based evidence” that Plan B is safe and effective for use by “all females of child-bearing potential.” Do you disagree with any of that?

    Even more…interesting is what you did not fail to do, i.e., excrete a steaming pile of unbelievably patronizing shit:

    “As I knew you would…” “you got entirely too worked up…” “it was meant to put things into perspective…” “being hypersensitive…” “I’m just trying to keep things real…” “Settle down there…”

    You forgot “Little lady.”

    Nevertheless I will ignore your condescension for the time being, and martial all the feeble resources of my overly emotional, highly irrational, clearly inadequate ladybrain, and focus on replying to your content.

    As I knew you would, you got entirely too worked up about my response. It was not meant to champion the decision about the morning after pill it was meant to put things into perspective instead of being hypersensitive to one small part of an issue.

    [Ignored as promised.]

    The vast majority of women can still easily obtain the Plan B pill

    This statement is at best a wild exaggeration with respect to young women, the demographic under discussion, and in particular those in poorer neighborhoods. But let’s move on.

    and I believe that it needs to be available.

    [Ignored as promised.]

    I don’t have children but if I had a young daughter who needed the Plan B pill I would want to know about it.

    And I would like to think that if you were a parent, you would have the kind of relationship with your young daughter where she would feel she could tell you. But this is not about you. Every parent is not like you, and even if they were, there will always be parts of their children’s lives that are beyond parents’ control. Tragic consequences can and do result in such situations. Consider that if she cannot obtain Plan B, you’ll likely find out about your young daughter’s more advanced pregnancy. Is that really a better outcome?

    That’s just me.

    No, it isn’t. On the contrary, there is a long and illustrious list of panty-sniffers with whom you are currently keeping company.

    I understand that my thoughts on the subject don’t fit every situation.

    That’s the most insightful thing you’ve said here. And yet you do not draw the obvious conclusions from it.

    As for Obama, I agree with you. I’ll be holding my nose as well but try visiting: http://whatthefuckhasobamadonesofar.com to see a list of accomplishments. Many people seem to harp so heavily on his faults that they forget to remember his accomplishments.

    In keeping with my earlier promise, I will assume that you were not sneakily insinuating that I am one of these “many people” who “forget to remember his accomplishments.” I have visited that link before: it’s clever and amusing, and makes some good points about the (relatively few, in my opinion) positive outcomes of the Obama presidency. Indeed, it is exceedingly difficult to forget his accomplishments with so many cheerleaders defending him, even when he does the indefensible.

    This is a conservative-bashing blog. When Obama enacts conservative policies, I am going to bash him. And mock him. Relentlessly. If this makes you uncomfortable or unhappy, I suggest you take it up with him, because that is where the problem lies. Not with me fighting for liberal policies and defending liberal principles.

    When Obama and other Democrats who campaign and fundraise as liberals do things that I agree with and support, I consider it (a) unremarkable that they are doing precisely what they were elected to do, and (b) politically practical and expedient for them to do so — or else they would not be doing it. I don’t write Letters to the Editor, strategize with other progressive activists, take to the streets, or blog about it (though sometimes I do). I go right where the leftward pressure is needed, because it is clear to me that supporting politicians no matter what they do is not only dangerously counterproductive, it is the very reason we have the (conservative and corrupt) government we do.

    I’m just trying to keep things real.

    Whilst I, on the other hand, continue to live obliviously in my delusional La-La-land. [Whoops! I forgot to ignore this, as promised. My bad.]

    Sorry if you took it the wrong way.

    Thanks for the textbook notpology, but I took it exactly as you wrote it, with the good faith assumption that you meant what you said. And if I have misunderstood you, I ask you — again — to please clarify.

    You know I have nothing but respect for women and their reproductive rights.

    Evidence in this thread points to the contrary.

    Settle down there terminator!

    Tell you what: I’ll “settle down” when you live under constant threat of your blood and organs being harvested against your will, simply because you had sex (consensual or otherwise). I’ll pipe right down once you’re in danger of violently tearing your perineum (yes, you have one) as a direct consequence of restricted access to contraception, which is what you’ve defended here. And I will totally STFU and take a goddamn nap when your life is endangered by an unwanted pregnancy, as mine (and the lives of many, many others) would be. And I will keep right on snoozing when your “allies” minimize the issue as a distraction. (I still don’t even know what you think this issue is a distraction from.)

    You are more than welcome — encouraged, actually — to disagree with me. Discussion is how we can all learn, which is the very reason I started this blog. But your reply does not constitute “discussion” by any stretch. I learned precisely nothing about where, how, or why I might be mistaken in either my reasoning or my facts. Instead, I learned that you (a) have an unfortunate tendency to ignore every salient point under discussion, and (b) tend to condescend in my direction, on my own blog. (Whether you do so intentionally or obliviously is not clear, but frankly I’m not sure which is worse.)

    Just a friendly suggestion: you may wish to contemplate the reasons for the existence of this blog, as well as the kind of discourse you’d like to be engaged in here, and then consider the content of your comments accordingly.

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