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May 06 2013

FDA Changes Rule on Plan B Contraception

A few weeks ago a federal judge ruled that the Obama administration had acted in a manner that was “arbitrary and capricious” in not allowing Plan B contraception — the morning after pill — to be sold to girls under 17 without a prescription. The FDA has now approved it for sale to those 15 and older.

U.S. regulators on Tuesday approved Plan B One-Step emergency contraception for sale to girls and women ages 15 and older without a prescription and on store shelves instead of behind pharmacy counters, Food and Drug Administration officials announced.

The move, which grants an amended application by drugmaker Teva Women’s Health Inc., is a separate action from a federal judge’s ruling earlier this month that ordered the Food and Drug Administration to make the so-called “morning after pill” available to all girls and women of reproductive age, including those younger than 17.

“The FDA’s approval of Teva’s current application for Plan B One-Step is independent of that litigation and this decision is not intended to address the judge’s ruling,” agency officials said in a statement.

But the FDA had already approved this once, apparently in response to a separate application, and was overruled by Secretary of Health and Human Services Kathleen Sebelius. Her ruling, which President Obama supported, limited the sale to those over 17. And now the Obama administration is appealing the court ruling against that decision, which makes this all the weirder.

35 comments

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  1. 1
    John Pieret

    But the FDA had already approved this once, apparently in response to a separate application, and was overruled by Secretary of Health and Human Services Kathleen Sebelius. Her ruling, which President Obama supported, limited the sale to those over 17. And now the Obama administration is appealing the court ruling against that decision, which makes this all the weirder.

    This is … well … the Plan B political position. The administration wanted to avoid (as if they could) any claims that they were pushing abortions on underage girls. Now, since the prior rule was not involved in the suit, they revive it so that they aren’t accused of pushing abortions on underage girls under 15 and can say that they are appealing to make it 17.

    OK, it doesn’t make sense even then … but it is Washington politics which is not to be confused with sense.

  2. 2
    Tabby Lavalamp

    Remember, it’s vitally important to vote Democratic and not third party because otherwise who will protect women’s reproductive rights in the United States?

  3. 3
    jamessweet

    Remember, it’s vitally important to vote Democratic and not third party because otherwise who will protect women’s reproductive rights in the United States?

    At the national level? Well, yeah, pretty much.

  4. 4
    trucreep

    Huh…this is what Obama meant when he said he’d make policy decisions based on actual science and not politics???

  5. 5
    slc1

    Re Tabby Lavalamp @ #2

    If Rmoney had been elected, Plan B would have been banned for everybody.

  6. 6
    Modusoperandi

    It’s still Obama’s fault. He was really for the thing he was against, you see. It’s all a trick. First, he got the FDA to do the thing that he wants, then he “overrules” them with the HHS, then he activates one of his judges to overrule the overruling. Now he’s so-called “appealing”, and next he’ll activate another liberalactivist judge to overrule that, then he’ll bring out the EPA to overrule that, and then another judge and then the ATF and then and then and then…

  7. 7
    Raging Bee

    Remember, it’s vitally important to vote Democratic and not third party because otherwise who will protect women’s reproductive rights in the United States?

    Well, if you can specify a third party that’s ACTUALLY DONE MORE than the Democrats to protect women’s reproductive rights, let’s hear it. And no, pleasing words in their official platforms don’t count.

  8. 8
    Modusoperandi

    slc1 “If Rmoney had been elected, Plan B would have been banned for everybody.”
    That’s a damn dirty lie and you know it. It would still be available for those who could afford a quick trip to Europe or Canada.

  9. 9
    erichoug

    OK, there is going to be a ‘but’ and I apologize in advance for that.

    Let me start by saying that I am 100% in favor of birth control and contraception. I am also pro-choice and feel very strongly about protecting women’s health and reproductive freedom.

    I am also strongly in favor of making Plan B widely available without a prescription. So much so that I think they should give it out on request at clinics and doctors offices.

    But, If a girl is 15 and buying Plan B. That would indicate that she has been having sex. In most if not all states, 15 years old is below the age of consent. So, it is indication that the girl in question is the victim of statutory rape.

    I am not saying that these young women should be denied the Plan B. But, if you walk into a hospital with a gunshot wound, most hospitals are required to report it to the police.

    Actually, I am finding this more and more tricky as I think about it.

  10. 10
    Geds

    erichoug @9: But, If a girl is 15 and buying Plan B. That would indicate that she has been having sex. In most if not all states, 15 years old is below the age of consent. So, it is indication that the girl in question is the victim of statutory rape.

    So…um, you’re assuming that 15 year old girls only have sex with guys who are 18 or older? I’d be willing to bet that most 15 year olds have sex partners who are also 15 years old. Or maybe 14 or 16. I get that some places have really bizarre consent laws, but this isn’t really a conceptual problem as far as I can tell.

  11. 11
    Tabby Lavalamp

    And the responses to my last comment are why the Democrats will continue being able to support the oligarchy.

  12. 12
    Kevin

    I do not buy the “political” motivation hypotheses for one second.

    Why? Because Obama can’t be re-elected. He has absolutely zero “political” motivation with regard to Plan B. The fundies decry ANY contraceptive — emergency or otherwise. Limiting Plan B only to “sluts over a certain age” does not mitigate the fact that it’s used by “slutty sluts who had sex outside marriage and don’t want to get preggers” (like Dog commands for each and every sex act). /end fundyspeak

    There is zero political upside to this. Zero. Not even a little bit. Flat line is flat.

    Here’s my hypothesis, which is absolutely as evidence-free as the “political” hypothesis.

    Obama made the initial decision with his “Dad hat” on and not his “President hat”. (I agree that anyone who thinks Sebelius made her decision independent of White House involvement is smoking something a little too strong for the mid-afternoon). He now regrets it. But he can’t back down from the decision-making process (lest he lose both “Dad” face and “Presidential” face). So, we’ll be entertained by the Justice Department arguing in favor of a policy that has essentially been rescinded. Don’t know how that’s going to go — I suspect the principle isn’t the rule itself but the authority to create rules that’s at stake. In which case, the Justice Department will win the case, but the rule itself will still be 15+.

    I’ll repeat my familiar (and probably tiresome) discomfort over the approval of this drug for use in younger women despite the complete and utter lack of safety data of in women younger than 18. I’m slightly mollified by the lower limit of 15 (rather than any sexually active woman), but not by much.

  13. 13
    A. Noyd

    erichoug (#9)

    But, If a girl is 15 and buying Plan B. That would indicate that she has been having sex. In most if not all states, 15 years old is below the age of consent. So, it is indication that the girl in question is the victim of statutory rape.

    I… what? Are you serious? If she’s having sex with someone her age, as most 15-year-olds do, that’s not illegal. It’s only statutory rape if the guy’s several years her senior.

    Furthermore, if the girl is a victim of statutory rape, then the last thing we should do is interfere with her access to emergency contraception. Maybe your intentions are merely to keep a watch on such girls’ purchases in order to catch criminals, but you’d end up punishing the victims by keeping them from getting the pill out of fear of being interrogated.

  14. 14
    chezjake

    Has anyone, let alone the Obama administration, thought about what form of ID any 15-year-old young woman might have to prove her age? Most states don’t issue drivers licenses until age 16. It strikes me that the simplest solution to the ID problem would be removing all age barriers to the purchase of Plan B.

  15. 15
    Kevin

    Geds: In some states, any sexual encounter with an under-age girl is a felony, regardless of the age of the encounter-er.

    Others have Byzantine age-gap rules like this one (Alabama):

    A person commits the crime of rape in the second degree if: …
    (1) Being 16 years old or older, he or she engages in sexual intercourse with a member of the opposite sex less than 16 and more than 12 years old; provided, however, the actor is at least two years older than the member of the opposite sex.

    So a 16-year-old having sex with a 14-year-old, no problem. A 17-year-old having sex with a 14-year-old — BIG problem.

    It really is a state-by-state issue — in other words, an enormous landmine.

    Indeed, a 15-year-old asking for Plan B could trigger a felony investigation. (Of course, it might well be a felony — I assume that women who have been raped would be a prime market for this drug.) Probably a local law enforcement decision — and local LEOs are notoriously conservative around this issue.

    Nothing about this is going to be simple.

  16. 16
    Michael Heath

    Kevin writes:

    I do not buy the “political” motivation hypotheses for one second.

    Why? Because Obama can’t be re-elected. He has absolutely zero “political” motivation with regard to Plan B.

    Wildly untrue.

    The president has political ambitions that extend beyond his term from a number of perspectives. The first is to protect his legacy, which can best be protected by getting a Democratic president re-elected in order to nominate Democratically-nominated federal judges and Supreme Court Justices, along with maximizing the number of Democrat seats won in 2014, 2016, and beyond. Another is that the president is the effective head of the Democratic party, that obligates him to promote the best interests of his party in the here and now. A third would be to establish policy he thinks will result in the best subsequent results, again in order to establish and protect his legacy when in office.

  17. 17
    erichoug

    Look, I am not saying that I am in favor of prosecuting minors for having sex with other minors be cause I am not. But you can’t simply assume that a 15 year old is having sex with another 15 year old.

    There is a very real legal issue with a 15 year old having sex, and a 15 year old buying Plan B is an indication that a law has been violated in many jurisdictions.

    Should we just ignore this? If the same 15 year old presented in the emergency room or doctor office with evidence they had sex, correct me if I’m wrong, but that would trigger certain mandatory reporting in many locales.

    Again, I am not against Plan B. But I am against childhood sexual abuse and it definitely presents an interesting conundrum here.

  18. 18
    d.c.wilson

    “There is a very real legal issue with a 15 year old having sex, and a 15 year old buying Plan B is an indication that a law has been violated in many jurisdictions.”

    The thing is, because we don’t have a federal age of consent law, a 15 year old having sex isn’t an indication of a federal crime, so there’s no reason to address this in federal policy. There is, however, a federal law that does have an effect here: HIPAA. If a 15 year old buys Plan B, how is the pharmacy going to report this to the authorities without violating the privacy of her patient records?

  19. 19
    erichoug

    D.C. Wilson

    If she is buying it OTC then I don’t believe patient confidentiality would come into play would it?

    I don’t know, the more I think about this the murkier it becomes. I mean I don’t want to prosecute minors for having sex with each other. And I definitely don’t want anyone under 18 to get put on the sex offenders data base. But, how do you deal with a 15 year old who is having sex with say a 35 year old man? Or one that was raped but doesn’t want to tell her parents or the police?

  20. 20
    D. C. Sessions

    But, how do you deal with a 15 year old who is having sex with say a 35 year old man? Or one that was raped but doesn’t want to tell her parents or the police?

    Or one who was raped by her father or the star quarterback and knows what will happen if she blabs.

  21. 21
    A. Noyd

    erichoug (#19)

    But, how do you deal with a 15 year old who is having sex with say a 35 year old man? Or one that was raped but doesn’t want to tell her parents or the police?

    You deal with it at some other point than monitoring how she cares for her reproductive health. Because if girls know that they’re being monitored, it will scare them off from getting emergency contraceptives. It will scare off the girls having consenting sex as well as the ones with statutory rapists for partners, too. And since girls usually don’t report (non-statutory) rape because they know they’ll be the ones punished for it, using their access to contraception against them would be especially cruel.

  22. 22
    erichoug

    @ A. Noyd

    Isn’t what you’re suggesting a free pass for a rapist an/or a pedophile?

    At what later point do you suggest that law enforcement follow up with them? and how exactly?

    Also, if you are minor under state law then you are not capable of consenting to sex, regardless of the age of your partner.

    I am not saying I want to scare these women form making informed BC choices and I certainly don’t want to deny them this or any other option. But, how do you parse out the young girls who are fooling around with their same age boyfriend from those who are being abused?

  23. 23
    d.c.wilson

    “If she is buying it OTC then I don’t believe patient confidentiality would come into play would it?”

    As far as the purchase itself, no it doesn’t, but I think things get murkier if you try to use that as a pretext to probe into the sexual history of a minor.

    Then again, INAL.

    “But, how do you deal with a 15 year old who is having sex with say a 35 year old man? Or one that was raped but doesn’t want to tell her parents or the police?”

    The same way we deal with it now: badly. If the victim of a sexual assault doesn’t want to report it, there isn’t much the authorities can do. They can’t force her to swear out a complaint or talk about it with her parents. The availability of Plan B will likely have little impact on whether a teen wants to come forward about an assault.

  24. 24
    A. Noyd

    erichoug (#22)

    Isn’t what you’re suggesting a free pass for a rapist an/or a pedophile?

    Making girls afraid to report rapes or take care of their reproductive health needs is what gives rapists a free pass. We have to dismantle rape culture.

    Also, if you are minor under state law then you are not capable of consenting to sex, regardless of the age of your partner.

    All right, having sex that’s within the legal exemptions. It doesn’t change my point. Most minors are not rape victims just because they’re having sex. Scaring non-victims away from contraception in the name of hunting rapists is bad.

    But, how do you parse out the young girls who are fooling around with their same age boyfriend from those who are being abused?

    I don’t know a good solution, but going after girls when they’re taking care of their health needs after the fact is a terrible one. Any deterrent would be borne almost entirely by the girl.

  25. 25
    Ace of Sevens

    @erichoug: So we should make rape victims carry their pregnancies to preserve evidence of rape? If they aren’t willing to tell anyone, as your narritive assumes, carrying the pregnancy until it becomes impossible to hide at 5 months or so is the alternative. At that point, it’s too late to get an abortion in many jurisdiction and even if it is legal, it’s likely difficult to access and certainly riskier and harder on them.

  26. 26
    eric

    Whatever Obama’s and other politicians’ reason for continuing to act against this, I expect most of the civil servants over at the FDA and HHS in general are happy about the court ruling. There is nothing particularly wierd about nonpolitical civil government officials coming up with reasonable policy and being completely overruled by political appointees. (I am not saying that career civil servants always get policy right, but it seems to me they get it wrong less often than political partisans.)

  27. 27
    erichoug

    @ Ace of Sevens.

    I suggest you read through my entire post. At no point did I suggest that we deny Plan B to 15 year old girls. I am strongly in favor of this product being sold OTC and I am strongly pro choice.

    As I said earlier and what all the knee jerk reactions seem to miss is that if a girl under the age of consent is having sex, in many areas, it is a felony. When a young girl buys Plan B it is the same as someone with a GSW walking into the ER. It very well may be the case that they, or someone else accidentally shot themselves. But, it also may be the case that the round is from a police weapon and that the wounded in question is being actively sought. Regardless of what you tell the ER nurse, in many areas you have to report it.

    I agree with A. Noyd that we should be taking on the attitude in this country that sees the rape victim as the problem rather than the rapist. But again, it is an entire can of worms. How do you pares out the rape victims and the ones who are having willing (again a minor is not capable of informed consent in most areas) sex with a much older man from the ones that are fooling around with the guy that sits behind them in English?

    If 15 year old girl comes into the pharmacy with bruises and a black eye and buys Plan B, do you just ignore it, sell her the pills and send her on her way? what about the second or third time she comes in? What about if you start seeing 3-4 girls a week with the same bruises coming in all buying Plan B?

    There is a certain legal as well as moral obligation. Allowing the fact that this society has a poor reflexive response to rape victims doesn’t mitigate the responsibility of society to protect children from predators.

  28. 28
    D. C. Sessions

    But, it also may be the case that the round is from a police weapon

    Not an analogy I would prefer with regard to pregnancy.

  29. 29
    erichoug

    D.C. Sessions,

    Nor would I but you have to admit they have similarities that are relevant to the discussions. In many cases, the GSW isn’t something illegal, it is truly an accident. But in some cases, it is not so much an accident but something that the wounded doesn’t want to report either because they are afraid of getting themselves or someone else into trouble, for whatever reason. You can play hypothetical situations all day long. But in the end, it is probably best to let the people with the training, resources and experience to handle the issue to sort it out. amateur social workers and police are rarely effective.

    I think the real issue here is that this is not as simple as many people are trying to make out.

  30. 30
    D. C. Sessions

    In a country where a girl can be expelled for even mentioning that she had been raped, I’m not going to worry about law enforcement until the patient has been protected. Right now, all of the talk about potential rapists subordinates the immediate, urgent, and critical need to do no more harm to the girl, be she victim or no.

    If you want to train pharmacy clerks as rape counsellors, I won’t argue.

  31. 31
    Ace of Sevens

    erichoug: I did read your whole post. I realize you aren’t saying that 15-year-old shouldn’t have access to plan B, but that them buying it should trigger an investigation, so we shouldn’t sell it OTC tot hem. The problem is that your scenario assumes they don’t want to report the statuatory rape. What you are promotign amount to statuatory rape victims must report that they are raped to get plan B, so they just won’t get it if they don’t want to report and neither will a bunch of other girls who don’t want to answer uncomfortable questions to get it.

  32. 32
    Ace of Sevens

    Also, by your reasoning, shouldn’t we require teens to jump through hoops to get condoms to make sure there’s no statuatory rape we should be investigating?

  33. 33
    bad Jim

    If a teen with cuts or bruises walks into a store to buy bandages and antiseptic ointments, is it reasonable to call the police? The principle of least harm would suggest allowing them to take care of themselves if they can. The same should go for emergency contraception.

    As for safety, levonorgestrel is non-lethal, which can’t be said for bottles full of pain relievers or various household chemicals, the sale of which is not legally restricted.

  34. 34
    zmidponk

    erichoug:

    The real problem is that you’re advocating a ‘one-size-fits-all’ approach of always requiring an investigation if a 15-year-old buys Plan B. Yes, if there is a good, solid reason for thinking that a minor is being abused, it should be reported and investigated. The examples you’ve given aren’t good, solid reasons. Yes, it’s possible that a 15-year-old girl that comes in with a black eye and buys Plan B 2 or 3 times could be because she’s getting raped and abused – or it could be that she’s a boxer and is buying Plan B as the pharmacy is on the way home from the gym, and it’s not even for herself.

  35. 35
    eric

    erichoug:

    How do you pares out the rape victims and the ones who are having willing (again a minor is not capable of informed consent in most areas) sex with a much older man from the ones that are fooling around with the guy that sits behind them in English?

    Well, you could start by providing young women with professional medical access that doesn’t automatically interrogate them. This will encourage both innocents and victims to use it, which will likely result in greater trust between the medical staff and the customer, which will likely (but stochastically) increase the chance of self-reporting in the case of crimes.

    Your comparison to gun shot wounds is inapt in some very critical ways. With GSWs at least part of the reason for quesitoning is because authorities in such cases have a reasonable expectation that the person in the hospital might have contributed to or committed a crime. GSW questioning is not just to catch ‘the other person,’ its in part to see if the person sitting in the hospital is a dangerous criminal. This expectation is (largely) absent in the case of young women seeking contraception, so the total justification for questoning them is not as strong.

    Second, because of the acute effects of GSWs, questioning everyone who gets them is unlikely to result in innocent victims staying away from hospitals in significant percentages. The expected ‘social cost’ of doing that – in terms of people not seeking help – is very low. Unprotected sex does not have this acute, life-threatening quality, so the analogous social ‘cost’ of more people going without help is going to be higher. Put simply, given a choice between ‘proper medical care + interrogation’ and ‘neither,’ we can reasonably expect GSW victims to choose the former. We cannot reasonably expect sexually active teens to do so.

    Lastly, the comparison is inapt because of sheer numbers. The US census bureaus shows that in 2011 in the US there were ~21 million teens (aged 15-19). To first order most of them can probably be assumed to be having sex and, thus, wanting access to prophylaxis. Probably many times every year. For 2007 (sorry, I couldn’t find 2011), http://www.uphs.upenn.edu/ficap reports that there were just over 60,000 total dealths + injuries from firearms. Note that something like 10k-20k of those deaths will be suicides, which we probably shouldn’t count for comparitive purposes. Now, that is a horrible number and I don’t want to minimize or diminish the terrible impact of gun violence in the US. Nevertheless, you are talking about social issues that differ in size by two or three orders of magnitude. The intrusion on the population’s privacy (for a program of legally required questioning) is going to be orders of magnitude greater for the teen sex case than it is for the GSW case. The logistics of implementing such a legal requirement is going to be orders of magnitude higher too. I do not think that you can simply assume that questioning will be as effective or successful in the big case as it is in the small case; social policy, like a lot of things in life, is not scale-invariant.

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