Bloodless Coup

My favorite part of this was when the head of the FDA said:

He [Crawford, head of FDA] explained that while the science supported over-the-counter access for women 17 and older, the agency had not figured out how to do that without younger teenagers getting the pills.

How about just asking for ID? I mean, we do that for tobacco, alcohol, R-rated movies and fireworks. Those are perfectly secured against under-age people getting them, but "Plan-B" is so super-strong and super-morally wrong that it needs extra protection? I mean, what, the administration can't even find plausible lies anymore?

So what does the 16 year old do?

So what does the 16 year old do?

What happens to the 17 year old who buys EC for her 15 year old sister (or the aunt, grannie etc who buys)?

I'm not opposed to younger women having access. I'm just worried about the potential maze of restrictive (and punitive) laws that might result. This is more than a delay; it's a signal that there even if they pass it for "adult women" that there are going to be punitive consequences.

I need to stop reading. I swear.

what happens when 12 year old kids end up with tobacco and alcohol because someone of the appropriate age was willing to buy it for them?

i think prescription access is pretty important (i don't want something like that to be OTC in the way that aspirin is for anyone with $10 in his / her pocket). beyond that, what happens after purchase is a mystery with lots of potent and dangerous things. say, oxycontin, just to cite one example.

here's another thought experiment: if it's OTC, what's to stop a man from buying it when he knows he's been careless and dosing his partner?

i must admit, i'm a bit flummoxed on this one. i think there are legitimate reasons for concern (what significant hormones outside of the birth control context are OTC? any? hormones are not things to mess around with, and when you combine 12-year-olds and medications, messing around is inevitably what you get.)

So a young woman's agency over her own reproductive decisions is like buying cigarettes?

No, it's not like buying cigarettes. My point wasn't to start that sort of fight (I honestly haven't thought about it enough to have a position). My point was only that the head of the FDA seems to have forgotten that there are lots and lots of products that society/government has deemed harmful for minors, and that if that is his biggest concern with respect to legalizing "Plan B", then it isn't a legitimate concern, and he's being dumb.

baltar's point is taken, and in any case my point is not about equating cigarettes and reproductive rights.

but i have to ask: binky, would you write the law to permit a 12-year-old elect to have a hysterectomy without involving a parent or guardian? if not, why not? after all, it affects reproductive rights, an area apparently so sacrosanct that it is excused from the qualified, equivocal, and carefully circumscribed scheme that surrounds every other constitutional right.

choice-directed absolutism, while it serves a political purpose (since it faces off against absolutist rhetoric on the other side), descends ad absurdam all too easily. in no other area do informed people speak so absolutely, not even in the area of the fourth amendment, the first amendment, or the fifth amendment, all of which brook substantial circumstance-dependent exceptions.

the issue is more complex, and requires more elaboration, than 'BLACK!,' 'NO, WHITE!'

if reproductive rights are so absolute that they completely short circuit the guardianship relationship to minors, and comprise a right of greater magnitude and clarity than any other stated or found in the constitution, than i want to hear you come out and say that exact thing.

i believe abortion must be made broadly available, and i think Plan B is fine as a prescription, or age-restricted drug, but i can think of no colorable argument that supports the idea that it's somehow above the pragmatic circumscriptions to which every other constitutional right is undisputedly subject.

and to further clarify my thinking, i've never had problems with parental notification laws so long as there's an available judicial end-run, to accommodate dys- or non-functional family situations, emancipated minors, etc. it's worth noting that the notification laws that the supreme court has struck down are specifically those that do not provide escape hatches for extenuating circumstances to be determined by a judge. i think that's an eminently reasonable approach, just as i think it's eminently reasonable to vest in a judge the authority to determine what set of circumstances rises to probable cause sufficient to support a search warrant. granted, any one judge may have an odd idea about what constitutes probable cause, but we're administering a nation of 300 million here, not a nation of one.

and to head off any pithy rejoinders, i think the clear mandate of the fourth amendment is equal in import to any constitutional right, enumerated or inferred, protected by our constitution. not to mention that the liberty from government intrusion expressly protected in the fourth amendment is by my lights effectively indistinguishable from that liberty interest enshrined in the same 14th amendment under which roe was decided.

(now if you'll excuse me, i'm going to duck behind the nearest desk.)

My point about cigs (and presumably yours about hysterectomies) is that access to birth control - making no mistake that EC is birth control not abortion - is both very important and very relevant to the health of a 13 year old. The argument of the FDA is not about whether EC is safe for girls under 18. It is about whether we want to let them have it. EC for a 15 year old is as safe as for an 18 year old as for a 32 year old. Oral contraceptives are proven safe and effective (and yes, I know that opponents like to bring up claims - as they do with abortion - of unsupported and remote possibilities of harm) for women of childbearing age. Like it or not, a 14 year old is of child bearing age, and is just as safe using EC as her 18 year old sister.

As to the hysterectomy and parental consent... pregnancy does not require parental consent and it is much more dangerous than taking contraception. If we are truly concerned about a young woman's safety... oh wait, then we get the burkas, right?

Joshua,

As you note, most legal issues are better thought of on a case-by-case basis (hence, I'm against mandatory sentencing and three-strikes-you're-out federal rules, for example), but I'm going to have to side with binky here. From Armand's original NYT article:

In May 2004, the food and drug agency rejected Barr's application to sell its drug over the counter, saying the company had failed to provide enough information about how well girls younger than 16 understood the drug's label and whether they might engage in riskier sex if the drug was easily available.

In this case, the FDA is making the claim that it cannot sign off on the "Plan B" drug explicitly for moral reasons, not health reasons. The quote above makes it abundantly clear that the FDA was asking Barr (the company making the drug) to empirically/statistically demonstrate that "Plan B" wouldn't change the behavior of underage women (why isn't the FDA concerned with the behavior of older women?); as binky notes, there is no dispute at all with the health issues of the drug.

The FDA is just plain wrong on this issue, and is wrong in a dangerous manner. Allowing the FDA to become politicized to the degree that their decisions are based explicitly on moral/political grounds, rather than health issues, weakens the agency and the role of science in society. That hurts us all.

binky, the inflammatory burka shit has got to stop, unless your goal is to drive me out of this debate (in which case, presumably, it stops anyway). i'm not goading you; i'm trying to have a discussion. and i really don't appreciate the implication that i'm somehow aligned with radical islam.

if my argument's so terribly week, show me without the slurs.

baltar, the moral concerns are only part of the story promulgated by the FDA. for example, the FDA also indicated that "the company had failed to provide enough information about how well girls younger than 16 understood the drug's label." bad labeling leads to class actions in the billions. bad labeling leads to misuse and harm. bad labeling is properly the province of the FDA as it long has been. less politically controversial drugs often have been shelved for the same reason for decades.

now let me drop back for a moment: i want to be clear that i have no illusions about bush's and the right's motives on this. furthermore, i have no illusions about the independence of the so called "independent" federal agencies in these partisan times.

but my point has been and remains that hormones of any kind are not lightly administered. a woman requires a prescription for birth control pills. is that too a travesty? well what if i think that i can manage my pain better than an indifferent physician forced to carry too many patients to make ends meet to really remember the details of my circumstance? why shouldn't i have access to prescription painkillers, which range from the relatively innocuous and safe to the potentially lethal and narcotic?

why do we have an FDA? a prescription system? is yours a purely libertarian argument? if so, Gesundheit!; you can stop reading. what follows assumes that's not the case.

when the FDA throws up several reasons, you can't successfully reject their efforts by picking the most protean one, ascribing it to partisanship (no matter how accurately), and disregarding the alternative rationales submitted simultaneously.

i reiterate that as far as i know NO pill that plays with hormones is delivered OTC.

and i reiterate that this general area's philosophically polarizing tendencies absolutism kills debate. you continue to draw what seems to me a false dichotomy: all reproductive health products for all girls of child-bearing age (which is happening at 8 or 9 with some frequency these days) all the time versus stoning rape victims.

if it were that simple, there'd be no political controversy at all.

Joshua,

I don't know the complete history of hormones, or what is sold (or not) OTC these days. That being said, most other countries allow many, many more drugs OTC than we do. Most of Europe (more socialist, in general, than we are) allow basic antibiotics and stronger drugs to be bought by anyone. If you are dumb enough to take something without knowing what it does, that's your problem. I've got no problem seeing "Plan B" in that category (what's an overdose going to do? What is an overdose of a one-time, one-dose drug, anyway?).

That being said, a labeling problem is minor (billions in lawsuits? for labeliing? only in America). That is still not a sufficient reason. Look, "Plan B" is a contraceptive: those you don't need a prescription for, and it should be sold freely. If you want to argue it isn't a contraceptive, then we have to fight about "when life begins", and that's a long fight.

As I said above, a 13 year old can make the much more dangerous decision to continue a pregnancy to term and keep the child with no one's consent. Nor do we mandate pre-natal care (the equivalent to a prescription, perhaps?).

1. We allow her that right to pregnancy, which is the same right we allow to her older sisters.

2. We do not have evidence or argument presented that EC is more dangerous for the 13 year old than the 18 year old (and there seems to be no concern about this in the FDA statements).

3. The FDA express no concern for anyone having trouble reading the label who is not a teen (according to your quote).

Therefore the call to restrict access to EC for teens seems to be based on neither the equality of all reproductive women (in this case there would be health concerns for everyone about offering EC over the counter, and there are none expressed at this time by the FDA) NOR of concern for all women who would have trouble comprehending the label. Like newspapers, OTC meds have to be written to level understandable for the vast majority of the population...what's that, a seventh grade education? If the FDA is going to make a case that younger teens (seventh graders?) are going to have trouble reading it, then it sounds like a case that everyone who has a below seventh grade reading level is going to have trouble reading the label. This is not what the FDA is saying, or they would be addressing young teens and functional illiterates, the drug addled or poorly sighted who might not understand. According to your quote above, this is not what they are saying.

This inconsistency is what leads me to reason that the reason for the delay is a diversion to mask our queasiness about teenagers having access to contraception, and the associated unease with them having intercourse, dressing immodestly, dancing suggestively at high school football games and so on. Are they women who can have babies like other women? Of course they are. Is there a higher risk that teenagers as opposed to other reading-challenged women will misuse the drug? That has not appeared in any of the FDA's arguments. What has appeared is a concern about access: "the agency had not figured out how to do that without younger teenagers getting the pills." Not misunderstanding the directions, "not getting the pills." Here's someone honest about the motivation: "Senator Orrin G. Hatch, Republican of Utah and a supporter of Dr. Crawford, called it not 'a pharmaceutical issue as much as it's a social issue.'"

You bring up the point of "no hormonal medicines are lightly administered." Pardon us for being suspicious that it's only women who have to deal with the administration you're talking about. "NO pill that plays with hormones is delivered OTC." Actually, no. EC is safely and easily accessible over the counter elsewhere (Europe for example). The accurate answer is "not here, not yet," which is the whole point of the FDA process.

The whole class of drugs including Ibuprofen and Naproxin was not available OTC for a long time either. Why is EC so special compared to other drugs that have more serious side effects (e.g. read the naproxin list)? Because it "plays with" hormones? Naproxin "plays with" cells and muscles. Why is it worse to "play with" one part of the human system than others? EC is shown to be safe, and the FDA is not debating that. You'd think that concerns about playing with body systems would be even more emphatic with drugs that more people of all ages and all genders will use. EC treads into the territory of women's fertility, and that is what makes it different.

Interesting that you think burkas were meant to be inflammatory (watch your own self with characterizations of absolutism, dearie). You may not have been keeping up with the packaging of "anti-abortion, anti-birth control and pro-modest clothing" together. Want to hear about modesty? How about this lovely outfit? Rather burka like, thought the young woman doesn't have her vision restricted. Blithe disregard for the broader political agenda behind restrictions on women's access to reproductive control makes women not absolutists but mobilized to protect their freedoms. And looking at the FDA arguments ("whether they might engage in riskier sex if the drug was easily available") shows that the concern is behavioral control of women . Unless that behavior is giving birth.

Huh. When I started this thread I expected it to be more of a "golly, look at the Bush team bending the rules (or breaking the law) AGAIN to have their way" or maybe a "yup, here's more of that think-of-the-children nonsense gettin' in the way of adults living supposedly free lives" - but hey, if ya'll want to fight over the proper behavior of the FDA, here's an idea that just floated to the top of my head (so it might be a really dumb one, but here goes). Why not, after preliminary tests, allow a lot more pills to go on the market and be sold OTC, but make it clear on them (I'm thinking big red stripes and warnings with bold captions) that these pills might not be "safe" and, say, direct people to government websites so that they can check into what's known about the pills already - and you can make the choice to take the risk of taking them or not, given that info. I'm not saying we don't want to keep an FDA-approved track, but what about another track for other drugs too? Myself, I think there are far too many things that require prescriptions and/or are illegal, so at least at 11:56 this morning, this idea works for me.

If you read Food Politics, you'll never look at the FDA the same way again.

My extensive argument above does not imply that I want the FDA to release a drug that isn't safe. The drug is safe, and there seems to be no questions about that. The "controversy" (teach it!) is over whether we are socially comfortable with acknowledging that young women have sex and want/need contraception.

I have lived in other countries where access to what in the US are prescription drugs - barring opiates but including oral contraceptives - is virtually unrestricted. It is much less expensive and much more convenient, and mostly safe. It's not that the drugs are less safe, they are still tested fully, but their distribution is different. Pharmacists have a much different role, clearly. And perhaps in those societies people can tolerate that "mostly" better than we can here (or perhaps they are not so litigious).

"And perhaps in those societies people can tolerate that "mostly" better than we can here"

So why is that - across a wide variety of cultures - true?

Oh, and Binky, I posted my 11:57 comment before seeing your 11:50 one, so I wasn't responding to that.

Oh, I know. I just started it at 11:50.

Oh, and for the record, our system allows girls - of the age we are talking about preventing from getting EC - to make the decision to marry and bear children.

From the NYT about the case of the 13 year old marrying the 22 year old In Kansas because it's illegal in Nebraska.

"A judge in Syracuse last September delayed a one-and-a-half-to-three-year prison sentence until this summer so that a 38-year-old defendant could marry a pregnant 16-year-old; in Florida in 2001, charges were reduced to a misdemeanor when a 17-year-old married the 13-year-old girl expecting their second child, and he received six months' probation."

Lest my point be misinterpreted, no, I do not think it is always a good idea for 13 year olds to get married. I do however find it inconsistent that the law lets these girls decide to marry - and marry men the state considers to be rapists at that - and bear children, but not to get safe emergency contraception.

And as Jessica points out "parental consent or notification laws only apply to unmarried teens." So, you're not capable of deciding to abort or use EC because you are not developed enough mentally to understand the consequences of your actions (I'm guessing on the exact motivation) but you are developed enough to decide to marry AND to bear a child whether married or not. And magically, if you can decide to get married, then you can make the decision about contraception/abortion. Perfectly logical.

thank you for taking the time to respond more robustly. i'm much clearer on your position, recognize the validity of much of it, and will cogitate further on my thoughts.

hopefully needless to say, i acknowledged the obvious latent social agenda in the decisionmaking process on all of this, and was pursuing it in some ways as an attempt to dig into a suite of reasons forwarded by the FDA. we all agree that bush is bad, and that he's doing terrible things to separation of powers, and just in general maladministering the country into a rather frightening logic deficit.

the FDA being what it is, however, i remain not entirely convinced that it is being all that terribly inconsistent on this, by comparison to its other decisions on reproductive drugs and other things (with regard to the federal government, for example, i think the issue of medical marijuana is philosophically and politically and legally riveting). its not only fair but utterly american to visit and critique a policy decision on its terms. but as bad as bush is, i think it's too convenient sometimes to just say, "well, there go the evangelists stealing the country again," and not engage in a deeper critique.

which you have unequivocally done in your last couple of posts. so thank you.

and i still think the burka thing was a slur, or a cop out if you prefer, but that small affront is long since remedied. :-)

Thanks. I'm sorry if I was not clear in the beginning. I do get somewhat excited.