FDA rejects Plan B

I don’t understand. What political reason could one possibly have for not allowing its OTC use?

I disagree with them about it, but I think it’s a reasonable position for them to take.

Incidentally, I noticed the other day on MetaFilter someone arguing that levonorgestrel (Plan B) was not at all like mifepristone (RU-486), which isn’t exactly true and what you wrote, Maria, isn’t exactly true, either.

Mifeprestone is definitely an abortificant, inducing an abortion.

Levonorgestrel, in contrast, mostly is thought to prevent conception by interfering with ovulation and/or fertilization. However, it also may prevent implantation. In the latter case, conception has occured, just as it has with an IUD.

Now, how one defines “conception” might be fertilization (most likely in the case of pro-lifers, I think), or implantation. For the person who prefers the former definition, one couldn’t call an IUD a contraceptive, but one could still say that, mostly, levonorgestrel is a contraceptive, but sometimes is whatever such a person would term a prevented implantation.

If a pro-lifer believes that a human being comes into full existence (poof, there’s a soul) at fertilization, then they should be much less opposed to levonorgestrel than they would be the IUD—except, of course, that sometimes it works the same way an IUD works. I suspect this is what most (at least of a certain type of) pro-lifers believe.

If a pro-lifer puts the magic moment at implantation and not fertilization, then one would expect they wouldn’t have a philosophical objection to levonorgestrel. But those folks probably will, as well, for practical reasons, and not unreasonably so.

From their view, the practical problem is that this would be an over the counter pill that, from a consumer standpoint, stops a pregnancy within several days of intercourse. Mifeprestone, from the consumer’s perspective, does the “same” thing within 63 days. In the pro-life view, it’s not a big jump from otc Plan B to otc RU-486.

But note also that they do have a philosophical justification for opposing it in general, because part of the time it is effective after fertilization occurs (assuming their objections are built around life at fertilization and not implantation).

keith: that’s all very interesting, but, I think it misses the point. I may be naive, but I think it is fundamental that everybody acknowledges that the point of legislating (as opposed to having an opinion or belief) on such matters is not to establish what “pro-lifers” (or pro-choicers, or anyone at all, for that matter) believe about when the moment of conception starts and when life starts and so on, and who can be possibly right or wrong – but simply to grant the right of decision over a pregnancy, all of it, in its entirety, at any time, to the only person who can decide about it: the woman being pregnant.

A “pro-lifer” may believe what he likes. Science may prove or disprove anything. But ultimately, a pregnancy does not exist in a vacuum. A baby (an embryo, a potential baby, whatever stage it is) is not conceived and carried in a container in a lab. It’s inside a body of an existing person with existing full rights, and that person cannot be treated as a container.

The legislation simply must accept that is the only fact that matters to the law itself. There can be no other legitimate legal positions.

Then, anyone can judge even the pill as some grave offense to life or a murder or whatever, but they cannot force their views on everybody else, and they cannot get the law to approve them. That’s simply inconceivable.

In practically all existing abortion laws in different countries, it has already been established that when the rights of the (potential) child and those of the pregnant woman come into conflict, the latter prevail. Every step should be taken to avoid such conflict comes about at all, but ultimately it’s the woman who decides what to do and when and where.

So, the same principle defining those rights should apply also for these pills, _no matter how they may work and at what moment of conception/pregnancy they have effect_.

Otherwise, it’s just a whole incoherent mess of ideology with no basic legal principle at all. (Duh..).

Depressing, but not exactly surprising. The Bush Administration has packed every position possible with anti-choice men. We have an Attorney General who calls the Pill “Baby Pesticide” and believes that both it and IUDs should be illegal, for heaven’s sake.

matt: yes, of course, you’re right, the legislations are not the same everywhere and in many cases they’re being constantly polluted by ideological disputes rather than remain anchored in legal principles per se. So, I guess I was thinking more of the ideal situation than the actual one.

But point is, even within the existing legislations of most countries where abortion is legal, there is often such incoherence there in switching from one principle to the other, and it’s so outrageous especially because that principle of the woman’s decision – not just the health of the mother consideration, but the right of an individual to decide at all – is there, it is indeed implied and/or overtly stated in other parts of the legislation and/or constitution so… It’s just so infuriating it should just suddenly disappear round the corner just because of the political pressures. That’s not how laws should be made. Especially laws that define what an individual is and what his/her rights are.

And in sayind that, I do not mean to be dismissive of the considerations over the rights of the fetus, or of the debate on that. It just seems to me those considerations, for legislators, should really be kept within more strictly legal terms and with more coherence.

Instead, the misreading of that crystal-clear prevalence of rights, basic rights, as some sort of outlandish and offensive demand of feminist superpowers has dripped into the law itself and so legislators no longer care for that coherence.

Assumedly in countries which ban abortion all together, (many south american countries, Irland, at least until quite recently, etc.) the idea that the rights of the pregnant woman trump those of the fetus whenever they are in conflict is surely not followed.

Actually it is, when for instance there are cases of illness that require a surgical or medical intervention where doctors and patient have to make that decision. Also, there are sometimes exceptions to a ban for cases of rape, for instance. That’s an instance of incohrence. Why should I be given the choice only if that conflict of rights appears in such extreme forms? Why not allow me to decide how serious that conflict is for myself, since I’m the one person who’s pregnant?

It’s contradictory to allow the choice in one case but not in others. Just as it’s plain absurd to allow abortion but not the morning-after pill.

If anything, the latter is less traumatic, less painful, less awful for everyone involved. Ah but that’s why the fanatics don’t want it allowed. But if the “thou shalt suffer” is the principle then we should ban caesarean section too…

It’s nice to say that a woman cannot be treated like a container, and I certainly disagree w/ that. Unfortunately, that’s something that seems to be up for dispute in the debate, and it’s not at all obvious that our side will win.

I know, I know… But see, it seems just plain incredible to me that we should simply accept that the principle that “a pregnant woman is a person, not a container” is a nice thing to say, but not acknowledged and accepted. It actually is, in one half of the legislation – it isn’t in the other… That’s the problem. Legal schizophrenia.

There are other similar cases, such as laws which treat drinking by a pregnant woman as child abuse.

Oh gosh, I didn’t even know that. That’s mad. Where? In the US?

The final decision was apparently based on the belief that as an OTC drug, emergency contraception might be misused, or available to under-16s. In practice, I think that’s unlikely: emergency contraception is not the sort of thing that any woman (or girl) is likely to use in lieu of other methods, given the short-term effects of such high doses of hormones. It’s rather like suggesting that there’d be a misuse of free-on-demand stomach pumps.

One problem, though, is that the US doesn’t have — nor, apparently, does the FDA have the power to implement — an equivalent to the ‘behind the counter’ sale of pharmaceutical products which is common in Europe.

(For Americans: this is a situation where certain products are placed behind the pharmacy counter, and can be bought without prescription, but only after consultation with the pharmacist or an assistant. In many cases, it’s just routine — ‘Are you taking any other medication? Have you used this product before?’ — but it’s a way to flag up any potential problems and lessen the risk that ‘stronger’ medications don’t end up in the wrong hands.)

Emergency contraception is a great example of something that would benefit from a behind-the-counter regime in the US. As someone noted in the NYTimes report, cigarettes are sold ‘behind the counter’ to avoid underage sale; but the morning-after pill apparently cannot.

What I find particularly depressing, though, is the way in which there’s so much misinformation on this subject within the US, particularly wrt emergency contraception and RU486.

I’m not normally a one hand or the other type of guy, but it is a bit odd to ascribe the polarization of the abortion debate solely to the pro-life side. If I could convince a majority of pro-lifers to exchange the OTC status of this pill for rules banning late term abortions (let us say as defined by when the fetus could survive outside the womb) except for a very narrow exception where the life of the mother is significantly placed in danger AND an abortion is safer than other methods of removing the fetus from the womb, would the pro-choice side take it? I think not. Yet that compromise represents a pretty close mapping of the general American’s understanding of what a well-struck abortion rights balance would look like.

Most people argue that because the IUD works by preventing implantation just like the morning after pill they must be morally equivalent. There is a critical difference. IUD’s are action taken before conception, when nothing exists that could possibly have rights. Morning-after pills are taken after conception, when there is a fertilized egg, that might be considered to have rights. It is logically consistent to claim it is morally acceptable to harm individual who don’t exist, and then bring them into existence, but not harm individuals who do exist

Sebastian,

I think that such a compromise, in and of itself, would be acceptable
to a substantial majority in the country. However, neither side has much
incentive to compromise, because then how would they raise money, and get
voters excited to vote? And both sides would see it as “the
tip of the iceberg”.

Discouraging, to say the least.

Rachel: individuals in legal terms are usually defined as persons existing from birth to death. Not before, not after.

It may be only a convention, because while a dead body is an inanimate corpse, one minute or one month after death, no debate about that, a baby one minute before birth is exactly the same as one minute after birth – but he’s not a legal person yet.

While there is obviously debate on what sort of legal rights unborn but developed fetuses have, they most surely do not have the full rights of a person as defined in the standard terms – much less a fertilised egg.

Otherwise, you might as well go as far back as… every sperm is sacred…

Uh … is Rachel arguing that a fertilized egg has more rights if the woman it happens to be in was taking the pill or has an IUD vs. if she wasn’t? That’s what I’m getting from it.

That or she doesn’t understand how the pill, IUDs, and Plan B work (all the same — they all stop fertilized eggs from implanting in the uterus after they finish their journey down the fallopian tube).

If she is arguing that, by a woman taking the pill or using an IUD, she has more a right to dispense with a fertilized egg than a woman who wasn’t (because she was using contraception), then where exactly does a broken condom or a faulty diaphragm fit in?

what pepi said

“IUD’s are action taken before conception, when nothing exists that could possibly have rights. Morning-after pills are taken after conception, when there is a fertilized egg…”—Rachel

Well, “no” to your argument as I’ll elucidate later. But your wording is misleading; especially since what is actually happening is ambuguous.

Used to be, the thinking was that an IUD prevents implantation but doesn’t interfere with fertilization. But I see now there’s considerable opinion that it prevents fertilization (the copper, somehow). However, even those sources that claim that it mostly prevents fertilization say that it sometimes prevents implantation.

Similarly, levonorgestrel, it’s thought by most, apparently, to usually prevent fertilization, but also to occasionally prevent implantation.

So. If fertilization is the defining qualitative change for someone, then the status of both of these is ambiguous (but probably more acceptable than not, relative to a pure abortificat like mifeprestone).

To your argument:

Note that you’re using the words “conception”, “fertilized egg”, and “something existing that could possibly have rights”. If there is some amount of time, and of course there is, between fertilization and implantation , and one can prevent the implantation (and we know this happens), then I really don’t see how using the anti-implantation device/drug before or after sex has anything to do with anything. Because the event we’re discussing hasn’t happened yet. One might as well make a distinction between brith control purchased impulsively the night that one has sex (not valid by the same reasoning), or a week before, or regularly (both valid). That’s silly.

And I have a lot of objections to anyone on the pro-choice side of things using the language of “potentiality”, since that places the debate squarely in the qualitative ballbark of the most extreme anti-contraception position of the Catholic Church and others.

Finally, I don’t object to the rationale of the pro-lifers regarding their choice of fertilization as the magic moment. Biologically, it’s pretty undeniably a major qualitative change, probably the major change. But, in my opinion, whatever that thing is, it’s not a human and it’s not a living creature. Others disagree.

I think Rachel doesn’t realize that an IUD can be inserted up to five days after sex to prevent a pregnancy. And, it is even more effective than the morning after pill.

As someone living in Washington State, I have personally benefitted from easier access to the morning after pill. My state started the Emergency Contraception Pharmacist Pilot Project, which allows pharmacists to prescribe the morning after pill after receiving special training.

After we had our protection fail during a particularly bad time of the month, my girlfriend and I were panicked. It was a Saturday and we both had to work on Monday, so how could we get in to a doctor? Plus, I think her medical coverage was in flux (remember, a lot of Americans don’t have coverage). We hadn’t planned for that possibility (live and learn) and we weren’t in places in our lives or our relationship were we had even thought about having kids. Luckily, I found out about the pilot program over the Internet on Sunday while doing a bunch of research on the subject and we talked it over and decided to try it. So, Monday morning she picked up the Plan B while on way to work and took it (about 36 hours after). She was very nauseous that day and we were both very nervous for the next week or two, but if that had not been available, I don’t know what we would have done. Probably waited very nervously for a month or two and then weighed whether or not to have an abortion.

It seems that the pro-lifers prefer we be forced to choose the second option, gambling that when push comes to shove we’ll decide against an abortion (or it won’t be available). That they feel they can make that choice for us just sickens me.

I always found it kind of amusing (in a sick sort of way) that our protectors at the FDA were going to drop the permission-slip requirement for the morning after pill, but not for birth control pills that are essentially the same medicine but packaged in a form much more convenient for preventing conception.

I say we abolish the FDA. Who’s with me?

“Biologically, it’s pretty undeniably a major qualitative change, probably the major change”

See, this I just don’t see. Two cells containing 32 chromosomes become one cell with 64 chromosomes. There are no organs. There is no heart. There is no brain. There is not even circular or nervous tissue. There is nothing at all that would make it recognizable as a person. You can’t really say with confidence “if not interfered with, it will become a person” until implantation. Even the “soul” argument–that if there’s a single moment when it forms, it must be then–is a little odd when you start thinking about identical twins.

Not that it’s an illegitmate belief, but I wouldn’t say it’s a belief as reasonable as any other.

circulatory tissue, that is, not circular tissue.

If you believe life goes from “not present” to “present”, from 0 to 100, at the moment of fertilization, it follows pretty logically that the birth control pill should be illegal and that the morning after pill should not be available even for rape victims.

So however sincere or legitimate the belief that life begins at the moment of fertilization and Plan B is murder, or at least attempted murder….I find it troubling when that belief drives the actions of the Food and Drug Administration.

“helping pro-lifers see the reasonableness of the pro-choice position, than vice-versa.”

And if I, grant that my premises are unusual, take a radical pro-choice position it is precisely because I do see the reasonableness of some of the pro-life positions.

And yet feel myself neither morally nor emotionally equipped to tell that 16 yr old girl she has to carry the child to term. I am much happier, tho not at all happy, fighting with Sebastian.

Keith,
How am I not taking their viewpoint seriously? I simply don’t want their religious beliefs regulating my behavior. They also believe I shouldn’t be having sex outside of wedlock and if there was anyway to prevent me from doing so, I have no doubt that they would.

In a democracy, I believe we have to have an overwhelming societal interest to justify having the state regulate what an individual does with their own body. With drugs, we’ve justified it with the scientifically documented damage (some) drugs do to the individual and to our communities, as well as the fact that the majority of drug profits go to criminal organizations. And the regulation of drugs is still a widely debated issue.

Where is the overriding societal interest in forcing women to bear children they don’t want? There is no documented damage to the individual, no one outside the individual is materially affected, we don’t have a shortage of children, so what is it? There isn’t any societal justification. The only justification pro-lifers can offer is a philosophical argument heavily based on their religious beliefs. I think that any objective individual that values personal liberty should be able to see that the argument doesn’t come close to the bar for restricting personal liberty in a free society.

Look, I don’t have the answer. And I respect pro-lifers beliefs. I think you are missing the point when you try to make this debate about who’s beliefs are valid or right. The problem I have with the pro-life advocates isn’t their beliefs themselves, it is that they want to impose those beliefs on me, that they want to force my actions to match their beliefs and not my own, and for no reason except that they believe it. Believing that people should live together before getting married is a reasonable belief, but trying to force everybody else to have to live together before they can get a marriage license is not.

Wow. A 39th week abortion is really late term, huh?

For what it’s worth, by definition pregnancy does not begin until implantation. Birth control, IUD, and emergency contraception do not ever end a pregnancy, even if they do sometimes prevent implantation.

Some people claim that a fertilized egg has claims to be a potential person, because it has the genetic material of the person it would be if allowed to develop. That’s incorrect; it’s based on 1950s understanding of developmental biology. The genetic makeup of the person is not determined at fertilization; that happens later in pregnancy. Which genes get expressed in the developing fetus are NOT determined by the fetus’s genetic material at contraception; they’re determined by a complex negotiation between chemical signals from the mother, and chemical signals in the developing fetus. Contraception does not determine potential personhood; it’s a lot more complicated than that.

And finally, another claim some make is that preventing implantation is wrong because it prevents the development of a potential human that would have happened otherwise. That is also incorrect. Only about 10-12% of fertilized eggs actually make it to become full term fetuses (even in the absence of the IUD, abortion, etc: of 100 fertilized eggs, 50 will fail to implant. Of the 50 that do implant, 15 to 30 will fail in the next 3-4 weeks, and 15 to 20 more will fail before the end of the second trimester. Of fetuses that do make it to the third trimester, 10 will be stillbirths.)

So to claim, as the anti-abortion people do, that because emergency contraception sometimes prevents implantation, that therefore makes it the equivalent of killing something that would otherwise have become human, is nonsense. It’s a mixture of bad science and private religious belief imposed onto others.

Nancy, you’re either simply wrong or being intentionally misleading.

You say that:

“Some people claim that a fertilized egg [is] a potential person, because it has the genetic material of the person it would be if allowed to develop. That’s incorrect.“

No, that’s exactly correct. A fertilized egg has the genetic material of the person it would be if allowed to develop.

What you are describing is the subject of the science of epigenetics. You’re right that gene expression is developmental and subject to environmental influences. You’re wrong to imply (or, hell, say explicitly) that the genetic material, which is commonly understood as the genes, which from a molecular biology standpoint (your context) is the DNA, is not set at fertilization. It is, and it doesn’t change, expect for mutation. Period.

As to how significant epigenetics is to personhood; well, that’s open to discussion. What clearly shows both the validity and the limits of your argument are identical twins and the recent animal cloning experiments.

The fact that identical twins are apparently nearly identical, along with the data from twin studies, etc., indicate that the DNA sequence deeply anchors the phenotype. Identical twins share the same genotype, it’s set at fertilization. And of course it’s quite important.

On the other hand, identical twins are not the same person and no one claims that they are. And in the case of identical twins conventionally conceived and gestated, they share the same crucial developmental environment during gestation.

In the case of the animal clonings, it’s clear that epigenetics is very important, as clones clearly aren’t identical in many, many ways as were expected. My impression is that opinion is that both intracellular and extracellular inveironments play an important epigenetic developmental role.

The summary is that one’s genetic base is set at fertilization; but that’s a long way from saying that everything that makes one a “person” is set at fertilization.

But then, who other than some nutty biological determinists are making that claim anyway? I’m not. Essentially your argument is that environment is an important factor in personhood, which is true post gestation—but I doubt that you’d argue against personhood for a one-year old child.

So, really, you’ve just rephrased the old argument in new terms. The fact of the matter is that what makes a person a person is a complex interaction of factors and growth beginning from fertilization. From that moment till, perhaps, adolescence, all we’re talking about here is various rates of gradualistic changes. There’s no good place to draw the line if we’re talking about something as essential as “personhood”. Especially if we want to retain the sanctity of the personhood of newborns.

Secondly, your opening paragraph is tendentious:

“For what it’s worth, by definition pregnancy does not begin until implantation. Birth control, IUD, and emergency contraception do not ever end a pregnancy, even if they do sometimes prevent implantation.“

Note that no one in this thread, I don’t think, but certainly not I, has equated pregnancy with conception. Conception occurs at fertilization, pregnancy occurs at implantation. Your point, or “correction” would be valid if I or anyone else had argued that pregnancy begins at fertilization. But, interestingly enough, we didn’t.

I’m irritated with you because although you seem to be laying the facts on the line and speaking authoritatively, you’re actually being disingenuous. In refuting that prevention of implantation does not end a pregnancy because it has not yet begun, you’re making a straw man argument when no one actually equated pregnancy with conception.

Consequently, your conclusion:

“So to claim, as the anti-abortion people do, that because emergency contraception sometimes prevents implantation, that therefore makes it the equivalent of killing something that would otherwise have become human, is nonsense. It’s a mixture of bad science and private religious belief imposed onto others.“

…relies upon A) your refutation of your straw man argument; and B) your false (or misleading) equivocation of epigenetics and “genetic material”. And both of these either fail to refute, or avoid altogether, the proposition that the most significant, single qualitative change that occurs in a very short period of time is fertilization, which sets the genetic code, and after which gradualism reigns.

You’ll notice that this point of view isn’t relying upon potentiality (nor does it rely upon a religion or even a metaphysics). To argue that an unimplanted embryo is not potentially a person in the same way that an implanted one is, is to knock down another straw man.

It’s not a mixture of bad science, as this is question science as yet does not have a satisfactory answer. No scientist will tell you when “personhood” occurs. Some people will say, as I do, that it doesn’t occur all at once and certainly doesn’t occur anything near the beginning of gestation. Others might say in infancy. Still others might say at fertilization. Some might say implantation (because there are qualitative changes that happen then, just not as profound as happens at conception); and others might say at some stage of the fetal brain development. Basically, you can’t say that placing an emphasis at some point is “bad science” unless, frankly, you’re willing to forgo making the judgment entirely and not placing an emphasis at any point until it’s so well into development it’s beyond dispute (an 18 month year old, for example).

Is it someone’s “religion”? It could be but isn’t necessarily. It may just be someone’s metaphysics. The majority of Americans believe in the “soul”. And, yeah, some religions mark conception as the magic moment.

I remain completely baffled by the “don’t impose your morality on me”. This is what we do in a democracy. We agree upon some moral principles and enforce them by law. The early abolitionists were motivated by their religious beliefs; and, no doubt, the Southern slave-owners protested this attempt by the Quakers and others to impose their religious beliefs on them. What? You say that is different because the slaves were people and fetuses are not? That’s begging the question, and awfully convenient for your position, don’t you think?

If you’re gonna argue against the pro-life position, do so in good faith. Say, “No, I don’t think a soul makes a person at fertilization, whether or not I think a soul exists; and no, I don’t think an embryo or a fetus is a person, either. You have reasons for drawing the line where you draw the line, I disagree with your judgments.”

But to distort your opponents’ arguments, to equivocate, mislead, and argue irrelevancies, is to argue for your own position in bad faith, and undermines your credibility. Worse, I think, it’s just plain not nice because you’re implicitly making an ad hominem argument that is taking the form of “look at all the ways that I show their argument is invalid—obviously, they must have ulterior motives, or are just bad people to be making such bad arguments”. That’s the tone of your last paragraph, your conclusion, it reveals your true purpose, and it is the telos of everything that came before it.

I say this as one pro-choicer to another who also suspects our opponents’ motivations. But I argue against their assumptions, reasoning, and conclusions, not against their integrity and good-intentions.

Very well said.

Okay, please stop using the word legislation. This isn’t legislation. This is rulemaking, informal rulemaking, done under the APA, which does not give the executive government the right to do whatever it darn well pleases. It is expected to make a decision based on the evidence that is relevant to the guidelines set up by the enabling statute. Although, in rulemaking, the FDA is given deference to what the statute says, it’s interpretation must be one of those that is acceptable in light of the court’s traditional notions of statutory interpretation (Chevron, State Farm).

The decision, in light of the evidence, must not be arbitrary in relation to both the facts (APA), the policy (Dole/Tankers Case), or the alternatives presented (Nova Scotia). There is no “anti-Christian rejection” clause in the enabling constitution. Nor can it justify on the basis that it might do a legal act that it is otherwise entitled to. If Congress then hates the rule, they can act legislatively and prevent the rule from taking effect. That a rule be made solely on politics is antithical to administrative justice, regardless what Kagen and Strauss argue.

Come on…this is WRONG. You’re all Chris Mooney fans here.