Court Overturns FDA's Political Science Limits on Plan B Contraceptive

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U.S. District Court judge has ruled that the Food and Drug Administration had improperly denied women younger than 18 access to the morning-after pill Plan B without a prescription. As the Washington Post reports:

plan b

U.S. District Judge Edward R. Korman in New York instructed the agency to make Plan B available to 17-year-olds within 30 days and to review whether to make the emergency contraceptive available to all ages without a doctor's order.

In his 52-page decision, Korman repeatedly criticized the FDA's handling of the issue, agreeing with allegations in a lawsuit that the decision was "arbitrary and capricious" and influenced by "political and ideological" considerations imposed by the Bush administration.

"These political considerations, delays and implausible justifications for decision-making are not the only evidence of a lack of good faith and reasoned agency decision-making," he wrote. "Indeed, the record is clear that the FDA's course of conduct regarding Plan B departed in significant ways from the agency's normal procedures regarding similar applications to switch a drug from prescription to non-prescription use."

Reason detailed some of the political shenanigans over Plan B here and here

Whole Post article here

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  1. Chalk one more in the fight for free access (i.e without prescription) to pharmaceuticals.

    Next: Penicillin!

  2. “These political considerations, delays and implausible justifications for decision-making are

    Is he talking about TARP, or the FDA?

  3. This makes baby Jesus sad.

  4. damn, this is just not crimethinks or MadMax’ day

  5. In his 52-page decision,

    It takes 52 pages to decide that the State’s case was bunk?

    For me, it would only take one page:

    “The Constitution does not grant the Executive any powers to tell the People what they can or cannot obtain through voluntary trade regulated by the States.”

    Ok, not one page – 1/5 of a page!

  6. This makes baby Jesus sad.

    No argument there ( 😮 ), but the case is not about abortion (which should NOT be considered an abortion issue if it’s only 1 day after conception – about 50% of embryos don’t even implant themselves naturally, anyway).

    No, this case is about whether the Executive Branch’s caprice can trump individuals’ rights.

  7. That’s wonderful news for multiple reasons.

  8. U.S. District Judge Edward R. Korman in New York instructed the agency to make Plan B available to 17-year-olds within 30 days and to review whether to make the emergency contraceptive available to all ages without a doctor’s order.

    Better hurry up with that review. Granting rights to a 17 year old, and denying them to a 16 year old looks “arbitrary and capricious” to me. Especially if she has big hooters.

  9. FTG,

    ‘Chalk one more in the fight for free access (i.e without prescription) to pharmaceuticals.

    ‘Next: Penicillin!’

    Don’t hold your breath. As you point out, the judge could simply have given a 1/5 page decision declaring that the feds have no Constitutional authority to regulate medicine.

    (My only quibble with you is that neither the federal executive *nor* Congress has general authority in this area)

    Isn’t it interesting that, under federal law, a 71-year-old woman can’t buy penicillin over the counter, but a 17-year-old girl can buy Plan B over the counter.

    Tell us again about politicizing medicine!

  10. He called the FDA’s decisions “arbitrary and capricious.”

    Didn’t he also say they need to immediately make the drug open to 17 year olds? Isn’t that one additional age range of a year quite arbitrary in itself?

  11. I suppose I’m the resident microbiologist ’round these parts, so I’ll point out that OTC antibiotics are a bad idea. They’re already over-prescribed, and if everyone could grab a Z-Pack whenever they pleased, we’d be in a world of hurt in rather short order.

    Antibiotic-infused cutting boards and soaps are a bad idea, too. I’m not saying they should be illegal, but a reasonable argument could be made for it.

  12. “Better hurry up with that review. Granting rights to a 17 year old, and denying them to a 16 year old looks “arbitrary and capricious” to me. Especially if she has big hooters.”

    But no way can she be permitted to get a safe, legal and rare Brazilian bikini wax.

  13. “Tell us again about politicizing medicine!”

    It’s all about the pussy. We’re really no different than the islamofascists who throw acid in the faces of the unveiled.

  14. But Bronwyn- how are we going to evolve a superbug capable of wiping out the scourge of humanity and riddding Gaia of her pesky infestation of two-legged troublemakers?

  15. “Women younger than 18” are generally referred to as “girls.”

    There’s an issue of parental rights here that should be addressed. At what point does the state’s license to their daughters interfere with their right to raise them as they see fit?

    Children don’t have the full rights that adults do and shouldn’t. They are their parents’ responsibility. The libertarian case has to keep in mind the rights of the parents as significant, if not unassailable.

  16. “It’s all about the pussy. We’re really no different than the islamofascists who throw acid in the faces of the unveiled.”

    Yeah! No difference at all.

  17. *shhhh!*

    P Brooks, don’t spill the beans!

    /whispers
    Remember, we’re going to save conquer destroy the world with Golden Rice.

  18. This highlights for me a more fundamental question with respect to children and all aspects of health care:

    Aren’t children, by definition, incapable of making reasoned, balanced, decisions for themselves? Aren’t their parents supposed to, as a matter of custom and law, make decisions for their children?

    The deeper, principaled question here shouldn’t be should 17 year olds be allowed to purchase Plan B, but should 17 year olds (or 16, 15, 14, 8?) be allowed to purchase ANY over the counter medications of any kind?

    At what point as a society do we define the passing from childhood to adulthood, with all the rights and responsibilities that go with that?

    I personally don’t like the notion of a graduated entry to adulthood that we now have. Either you’re an adult, with all the rights and responsibilties that go with that: voting, contracts, booze, etc (don’t get me started on the whole 18 vs. 21 thing – its bullshit to have an 18 y/o in Iraq with a machine gun, but say he’s too irresponsible to have a beer at home with mom and dad) or you’re not an adult, and hence are not allowed to make adult decisions, including which pharamacuticals you can purchase and ingest.

    If 17 y/o’s are adults – then fine, pass a constitutional ammendment, and make it so. Else, they’re still children.

  19. John Pearley, can an under-18 gal get a prescription from her pediatrician for birth control pills, without parental consent?

    In most cases, yes.

    Does that help answer your question?

    PS. If anyone comes in here saying that Plan B will be misused as birth control, let me tell you right now that only a masochist would rely on it that way. It makes you feel *terrible* for several days. Certainly not something you want to do every time you have sex.

  20. “Yeah! No difference at all.”

    Not fundamentally. It’s really about controling women for alleged moralistic reasons.

  21. John Pearley Huffman, there is in realuty a sort of staggered scale for the rights of children.

    At birth, one can argue they have the right to life, once they speak one may argue they have the right to free speech, at puberty one could argue they have the right to their reproductive nature. At 18 they have the right to vote. Not all rights are granted at the same time. Some kids are tried as adults before age 18 because they have the ability to make their own decisions.

    I’m not suggesting I have an answer to every scenario, but to suggest that until the day they turn 18 all children are subject to the whims of their parents, is not supported by the reality of life on Earth.

  22. Now I’m confused.

    A 17 year old can buy contraceptives so she can have sex without getting pregnant, but the only way she can have sex is to be raped?

  23. I’m pretty sure my 5 month-old and apraxic 2 year old have full free screech rights.

    That counts, doesn’t it?

  24. “Aren’t children, by definition, incapable of making reasoned, balanced, decisions for themselves?”

    Can a 17-year-old girl bring a Plan B pill to her drug zero-tolerance school that suspends kids for possessing Advil?

    Can a school that prohibts her from doing so pass out condums?

  25. I think the parents of a teenager that needs Plan B have already proven themselves to be poor stewards of their daughter’s health and well-being.

  26. Oh, and the government allows minors to “assent”, rather than “consent”. They do have some rights to control over their own bodies.

  27. Oh noes, now the teenagers will be having sex!

  28. No Name Guy,

    Let’s try this scenario:

    A 15 year old, let’s call him Mike, calls the president a socialist fucktard in the piblic square. He is arrested and held without trial, cannot receive the services of an attorney, and is kept is solitary confinement until his 18th birthday.

    His parents are on welfare and love the president, so they agree Mike needs “rehabilitation” in prison for his views. Should Mike be treated this way for speaking out against the government? Afterall, his parents are on board and the government does not protect Mike because he is not 18 and has no rights of his own. Makes sense, right?

  29. Well if they get started in their tweens, you can’t expect them to stop for their teens, can you?

  30. In other news, Taco Bell launches a new ‘Morning After’ Burrito!

  31. Although 17 seems like an arbitrary number to legalize, it’s real just a way to pop the cherry on minors…

  32. If anyone comes in here saying that Plan B will be misused as birth control, let me tell you right now that only a masochist would rely on it that way. It makes you feel *terrible* for several days.

    So by that logic, everyone that does cocaine is a masochist…

  33. Taktix?,

    You feel bad for days afterwards? You need to stop getting that shit cut with baby laxative.

  34. I can’t say, Taktix, never having tried it.

    Plan B doesn’t give you any “feel good” or opiate effects. Maybe if you replaced “cocaine” with “salvia” in your statement, I’d agree.

    I’ve never tried that either, but the fellas around here seem to agree that it isn’t a pleasant experience that bears repeating.

  35. There’s an issue of parental rights here that should be addressed. At what point does the state’s license to their daughters interfere with their right to raise them as they see fit?

    The government standing aside on an issue is not a violation of a parent’s right to raise their kids as they see fit. The government making it mandatory that a parent allow their kid to buy Plan B would be.

    I’ve always found it amusing when some people claim that the government should stay out of a family’s business-usually one parent has bruised, welted or drawn blood from their kid in the name of discipline and is upset that the government has stepped in-this isn’t always the case, but this scenario shows up so much it’s a rule and the not the exception. Of course those same types of parents want the government to help track down their son/daughter if they choose to move out or if the kid refuses to listen. It seems that really only mind government getting involved when it doesn’t suit the parents’ purposes.

    Your logic as I read it would require the government to effectively ban for all teens anything that a majority of, handful of, or even one, parent wishes to deny their own kids. It would also effectively make the government a secondary/tertiary parent.

    The other half is rarely ever represented in the debate. What if a parent wishes for their kid to have immediate access to Plan B? Isn’t it an equal violation of their rights to deny them the ability to “raise their children as they see fit”?

    Children don’t have the full rights that adults do and shouldn’t. They are their parents’ responsibility. The libertarian case has to keep in mind the rights of the parents as significant, if not unassailable.

    My copy of the Constitution makes no mention of a reduced set of rights for people under arbitrarily set ages. If the government raised the age of majority to 25, would that justify adding 18-24 year olds to the list of people without full rights?

    As for “parents rights”, they are most certainly assailable. Children are human beings who possess rights regardless of what the courts have said. The primary purpose of the government is to protect one group of people from being violated by another.

    Parents have unique powers over their children because the government grants those powers, due in no small part to the (in reality, slightly) enhanced level of responsibility it places on parents. The government is the one that sets the age of majority, defines the
    “rights” (powers) of parents over their under-the-age-of-majority children, enforces those powers in some case, and punishes misuse/abuse of those powers.

    The government could lower the age of majority to 14 and all parents of 14-17 year olds would find their government granted powers and responsibilities removed.
    Would it then be a violation of “parents rights” that the government doesn’t take action when a 15 year old moves out against his parents’ wishes the way it currently takes no action when an 18 year old does?

    In short, if a parent doesn’t want their kid to have access to Plan B, that’s between them and their kid.

  36. This paragraph was meant as an aside-just something that I think ties in with the general concept, not this specific topic:
    (I’ve always found it amusing when some people claim that the government should stay out of a family’s business-usually one parent has bruised, welted or drawn blood from their kid in the name of discipline and is upset that the government has stepped in-this isn’t always the case, but this scenario shows up so much it’s a rule and the not the exception. Of course those same types of parents want the government to help track down their son/daughter if they choose to move out or if the kid refuses to listen. It seems that really only mind government getting involved when it doesn’t suit the parents’ purposes.)

  37. My copy of the Constitution makes no mention of a reduced set of rights for people under arbitrarily set ages.

    My copy has a 26th amendment.

    Along with Sect 2 Clause 2 of Art 1 as well as Sect 1 Clause 1 of sect 5.

    Although I mostly agree with your overall comment:

    ” If the government raised the age of majority to 25, would that justify adding 18-24 year olds to the list of people without full rights?”

    Yes, it would. With the caveat that it comes with the commesurate reduction in responsbilities – not being able to be charged as an adult in legal matters for instance.

    Fwiw, as others have said I would love for everything to be at the same age (and I’d pick that age at 16 not 18).

  38. You feel bad for days afterwards? You need to stop getting that shit cut with baby laxative.

    What’s “cut” mean? I live in South Florida, and I’ve never heard that word before.

    But of course, I’m just kidding, I never do bad things like drugs or sex or cursing…

  39. In fact, I would rather ‘adulthood’ be set by the accomplishment of something, vice an arbritrary age (along the same lines but not necessarily identical to the starship troopers scenario)

    I have no idea how to practically implement such a scheme, however.

  40. In fact, I would rather ‘adulthood’ be set by the accomplishment of something

    Like Xbox 360 games! My gamerscore is only 6000 or so, I’m not even able to drive yet I think.

  41. ‘Plan B doesn’t give you any “feel good” or opiate effects. Maybe if you replaced “cocaine” with “salvia” in your statement, I’d agree.

    ‘I’ve never tried that either, but the fellas around here seem to agree that it isn’t a pleasant experience that bears repeating.’

    Could it be possible that the users of Plan B associate it with something they deem “a pleasant experience that bears repeating?”

    ‘I’ve always found it amusing when some people claim that the government should stay out of a family’s business-usually one parent has bruised, welted or drawn blood from their kid in the name of discipline and is upset that the government has stepped in-this isn’t always the case, but this scenario shows up so much it’s a rule and the not the exception.’

    That’s a very interesting assertion.

  42. I’m curious: would the fact that a minor has obtained Plan B be evidence that she is, in fact, capable of making decisions about her sex life, so that whoever banged her couldn’t be charged with child abuse or statutory rape?

    If not, why not?

  43. Could it be possible that the users of Plan B associate it with something they deem “a pleasant experience that bears repeating?

    There are much more pleasant methods of birth control than plan B. High doses of estrogen make a very effective emetic.

    You feel bad for days afterwards? You need to stop getting that shit cut with baby laxative.

    Here, they cut it with livestock vermicide.

  44. I think the parents of a teenager that needs Plan B have already proven themselves to be poor stewards of their daughter’s health and well-being.

    Condoms can rupture, SugarFree. I remember my (age >> 17) gf having to go to a f*cking gynocologist to get a prescription for plan B after one such incident, circa 2002.

  45. RC Dean, you do realize that many if not most states have an age of consent of 16 or younger, right?

  46. I suppose I’m the resident microbiologist ’round these parts, so I’ll point out that OTC antibiotics are a bad idea. They’re already over-prescribed, and if everyone could grab a Z-Pack whenever they pleased, we’d be in a world of hurt in rather short order.

    Are they in a “world of hurt” in countries where OTC antibiotics are legal?

    There are a lot of peoplw who can get antibiotics “whenever they please” in this country.

    Should someone with a known bacterial infection have to pay the gatekeeper to get treatment?

    The most dangerous antibiotic resistant bacteria are bred in hospitals.

    A drug company developing a new patent antibiotic would have incentive to restrict distribution to prolong it’s effectiveness.

    As a matter of private property rights all drugs should be OTC as long as there is a willing buyer and seller.

  47. 71-year-old woman can’t buy penicillin over the counter

    It’s not a controlled substance. It’s not illegal for her to buy it OTC. It is illegal for someone to sell it OTC, but only if intended as a human or animal drug or diagnostic. It can legally be sold to her as a chemical for other uses, such as for maintaining penicillin-resistant bacteria in culture, and once she possesses it it’s perfectly legal for her to use it as a drug. It’s also legal for her to lie about what she intends to use it for.

  48. Nick

    Nice Straw horse. Note that I never said children are without basic human rights, including free speech. The right to free speech is a basic human right, regardless of age. Ditto the remainder of them as well.

    All I’m suggesting is that throughout the history of western civilization, children have been deemed incapabible of making informed choices for themselves.

    If children are allowed to purchase and take this medicine, what else, as a matter of basic first principals, are they to be considered responsible enough to do or purchase and ingest? Alcohol? Why not being able to enter into contracts? Why not being able to join the Army at 17? If a 17 y/o understands the possible side effects of this drug, what about every other drug out there?

    All I’m arguing is that 18, while arbitrary, is at least (mostly) the uniformily arbitrary boundary between the no responsibility of childhood and full responsibility of being an adult. It also has some basis in western tradition as the boundary between youth and adulthood.

    Besides, there are ways around it for individuals who have proven themselves capabible of taking on adult responsibilities at a younger age – specifically, petition a probate court for emancipation, for example.

  49. Are they in a “world of hurt” in countries where OTC antibiotics are legal?

    Evidence seems to be largely lacking. After all, OTC doesn’t necessarily equate to availability in the developing world – you need affordability and access, as well as purity. Most studies of drug resistance in developing countries are focused on TB, malaria and HIV. Still, we know that multidrug resistance in n. gonorrhea, which is a prime example of an infection likely to be treated without physician input, appears to originate in the developing world.

    So, if Cipro won’t cure your clapp, you can probably blame OTC antibiotic use in southeast asia.

    There are a lot of peoplw who can get antibiotics “whenever they please” in this country.

    This is not considered a good thing, btw.

    The most dangerous antibiotic resistant bacteria are bred in hospitals.

    And nursing homes, because that’s where the majority of antibiotics are used.

    As a matter of private property rights all drugs should be OTC as long as there is a willing buyer and seller.

    As a matter of public health, they should not. If your inappropriate use of an antibiotic threatens the health of others through increased resistance, you have no right to do it.

  50. Here’s something no one ever asks, until NOW: if some 16 year old chick gets pregnant, wants an abortion but her parents say no (assuming they live in a state where they have this power) who is financially responsible for raising the kid? If you know, please enlighten me, so I can vent further in other forums.

  51. Whaddya know, “The Child” is tonight’s episode of ST:TNG on WGN. Coincidence? I think not.

  52. Mari,

    Perhaps you can also vent over who has to support the baby if a guy wants an abortion but the woman says no.

  53. MRSA among other resistant super bugs, is found with great regularity on large feedlots, chicken and pig farms, where the animals are fed daily low doses of antibiotics for better growth and less disease in their shitty conditions.

  54. crimethink, that is one of my all time favorite questions. re: your 8:20pm post

  55. crimething,

    The man isn’t really a third party to the event the way a parent is. I’ll argue that by having sex, BOTH parties acknowledged at least all commonly known risks-including, but not limited to, the possibility that the woman may choose to have an abortion or not and that the man technically has no say in the matter.

    A parent doesn’t have a direct stake in the matter-they can force their 16 year old to have a kid and then throw them out-many states consider a pregnant teen emancipated to some degree. It would also be one of the only times I can think of where a parent can not only unilaterally, but dramatically, affect their child’s adult life. Parents can’t incur debt in their kid’s name, forcibly tattoo, donate organs, can’t have their kid sterilized, etc.

    One way to describe the situation where a parent believes they have the right to force their teen daughter to have their baby is that if the parent wasn’t there for the pregnancy, then they have no right to be there for the abortion. Read that on less of a literal level and more as “there in spirit” kind of a commentary on the parent’s parenting.

  56. ‘Condoms can rupture, SugarFree. I remember my (age >> 17) gf having to go to a f*cking gynocologist to get a prescription for plan B after one such incident, circa 2002.’

    Again with the anti-condom propaganda! Do you work for the Vatican? Don’t you care for AIDS babies dying in Africa?

    ‘[Penicillin is] not a controlled substance. It’s not illegal for [a 71-year-old woman] to buy it OTC. It is illegal for someone to sell it OTC, but only if intended as a human or animal drug or diagnostic. It can legally be sold to her as a chemical for other uses, such as for maintaining penicillin-resistant bacteria in culture, and once she possesses it it’s perfectly legal for her to use it as a drug. It’s also legal for her to lie about what she intends to use it for.’

    Ah, so OTC penicillin has the same legal status as alcohol in the 1920s: Legal to buy, but illegal to sell for the purpose for which it is most frequently used – as a beverage in the case of alcohol, as a medicine in the case of penicillin. And a customer can always pretend that they’re buying the penicillin so she could grow a bacterial culture in it, just as a customer in the 1920s could say that he needs alcohol for sacramental or medicinal purposes.

    That makes me feel a whole lot better.

  57. Fear not, Crimething, I will also vent on behalf of the unwilling father forced to shell out for child support. Like most libertarians, I’m opposed to children in all their tiresome manifestations, but especially when they’re the result of coercion by a third party.

  58. dbcooper,

    Condoms can rupture, SugarFree. I remember my (age >> 17) gf having to go to a f*cking gynocologist to get a prescription for plan B after one such incident, circa 2002.

    I was more getting at the notion that if the parents can’t keep their teenage daughter from having sex, why is it assumed that they are automatically competent judges if those same daughters should receive Plan B, an abortion, etc.

    I’m fine with BC, Plan B, Ru-486, abortion, voluntary sterilization, etc. I think being forced to have an unwanted child is a monstrous proposition for everyone involved.

  59. I would be more happy if it weren’t just another fight in the war between democrats and republicans. BUT, looking at the FDA appointees Obama has made, it is plainly obvious that increased freedom to do what we want with our bodies is the opposite of his agenda just as much as it is opposite of Republicans’. They just want to control different activities is all.

    Sigh. But at least it’s a little step forward.

  60. Like most libertarians, I’m opposed to children in all their tiresome manifestations…

    I think I may have missed that issue of the newsletter. How do I update my address with libertarian headquarters?

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