posted
The Washington Post is reporting today on the FDA's failure to meet it's own deadline for a ruling on making Plan B contraception an over-the-counter drug, rather than by prescription only. The problem, according to the FDA administrator, is that they've never had a drug be OTC for one age group (all women over age 17 in this case) and not OTC for all other age groups.
The obvious problem here appears to be politics. There's been a groundswell among the GOP to fight the increased availability of Plan B. And the pressure is coming from a lot of high level folks.
Of course, on the other side, this is also just as politicized. The Democrats are saying that they agreed to the FDA Administrator's appointment only because of the deal that there would be a decision on Plan B by this specific date. Now they feel "betrayed and outraged."
The questions that come to my mind are as follows:
1) From a policy standpoint, is an age range for prescriptions and another age range for OTC really all that unusual? It seems to me that most OTC drugs either come in "children's strength" and "adult strength" or have dosage recommendations, or have warnings about not giving them to some children. Is this really a radical departure?
2) Is the FDA supposed to be a "pure science" data-driven agency? We've been hearing of the political process of drug approvals at the FDA. I know of another situation where a perfectly good OTC treatment for swimmer's ear was yanked from the market because it hadn't been proven effective. Except that the Navy proved it 50 years ago for its divers and the prescription version of it is super-expensive despite the fact that you can make it yourself from OTC ingredients for about $3 a quart (works out to a per-dose cost of mere pennies). The recipe is even available from the Divers Alert Network online. This is a different kind of politics -- the politics of the FDA bowing to drug manufacturers and letting the consumer get ripped off.
3) Is this drug different because of the more serious consequences if it is abused? A massive dose of hormones is dangerous. But is the concern here over the medical consequences of that treatment in young girls or is the concern about abortion? There are OTC drugs that can kill if taken in sufficient quantities.
posted
I think the problem is that conservatives (I'm not saying GOP because I'm sure not all GOP members feel this way) seem to believe that availability of the Plan B pill will cause more young people to have sex. It's the same problem that comes up with condoms and the birth control pill and even sex education classes.
I understand their reasoning. In a way, saying that the Plan B pill is available is saying "sex is okay kids...and if you mess up and think you might be pregnant, here's a magic pill that removes all consequences." But at the same time, I think it's worse to leave people unprotected and uneducated.
So, yeah, not sure if I got on the right track with that answer...but I'll stick with it. Posts: 3852 | Registered: Feb 2002
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posted
Will B, that's true, but in this case, they've actually just shelved plans for coming up with a policy. They went from promising a policy by a specific date to saying they've postponed that decision indefinitely.
Posts: 22497 | Registered: Sep 2000
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posted
Javert, I think you're on the right track. I just wonder whether or not we should expect a different mode of operation from the FDA. I mean, is it okay to have a drug policy that is part science and part social engineering? Is it possible to have a drug policy that isn't political as well as fact-based?
Posts: 22497 | Registered: Sep 2000
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posted
But many drugs have social consequences and we regulate them for that instead of mere effectiveness. Look at how Sudafed was pulled from the market and forced to change its formulation - not because Sudafed didn't work, or because it was dangerous if used correctly but because it led to drug abuse because it was an ingredient in an illegal drug.
And of course the FDA must deal with politics as long as its government funded and its leaders are appointed, politics are going to play a part.
Posts: 14428 | Registered: Aug 2001
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posted
Good point Belle. And my question could be expanded to ask whether our handling of the Sudafed issue was the right way too. Rather than controlling access to the other ingredients in meth (like anhydrous ammonia) we went after a product used by millions. Why'd we do that? Is it more fair that way? Less intrusive? Or did the farmers have a stronger lobby than the pharmacies and the general public?
I agree that the appointment process is a direct cause of the politicization of all government agencies. I wonder if we should find a different way to run our government?
Posts: 22497 | Registered: Sep 2000
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posted
But, if one uses the argument that making the Plan B drug avaliable OTC, that's sending a message that it's okay to have sex, couldn't one also make the agrument that by having alcoholic beverages available OTC, it sends the message that it's okay to drink and drive? Or that by selling guns at Wal-Mart and K-Mart (do they still?), the real message is that it's okay to go out and shoot somebody?
I really don't think one has anything to do with the other, in any of those cases, just as I don't think teaching about birth control gives kids the okay to have sex.
Posts: 2454 | Registered: Jan 2003
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posted
lma, I agree. I think there's a bit of a smokescreen going on here. I think the real issue is that making Plan B available without a prescription will result in a large increase in uncounted abortions since many will use it as a prophylactic even though, in some cases, fertilization will have taken place.
This probably bothers a lot of people for a variety of reasons: 1) there are a lot of people who just think any abortion is wrong, period, and, 2) abortion will be more convenient 3) the numbers of them taking place will be unknown and unknowable, and thus difficult to make any political hay about.
Posts: 22497 | Registered: Sep 2000
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posted
If other birth control methods are okay, then this one should be as well. Unless it is proven medically, that under 17 year old girls have health risks involved with taking the pill, it should be made available to them. The pregnancy rate in America proves enough that teens, regardless of contraceptives are still going to have sex and get pregnant. We have the highest teen pregnancy rate in the western world, twice that of Britain's, who has the closest rate to ours. And that is after cutting it by more than 20% in the last two decades.
The FDA shouldn't be used as a tool for the crafting of a society. They are there for one purpose, to tell us what is safe and what is unsafe for us medically. Morals and standards of social conscience should be dictated by the society as a whole, not by a select few bowing to politicall pressure from on high.
Teens should have a say in this. Recent surveys have shown they, as a whole, want more information on contraceptives. Making more contraceptives available isn't going to give them a green light, they've already proven they don't need such an excuse.
Posts: 21898 | Registered: Nov 2004
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posted
I think the hesitation is because the FDA says there isn't ENOUGH information on the effect of Plan B on teen girls, not that has been proven unsafe.
At least that's what they are saying. They apparently thought they had a way to craft a policy related to this some time ago, but the pressure they're under to NOT make Plan B an OTC medication is causing them to rethink that policy.
Posts: 22497 | Registered: Sep 2000
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quote: But, if one uses the argument that making the Plan B drug avaliable OTC, that's sending a message that it's okay to have sex, couldn't one also make the agrument that by having alcoholic beverages available OTC, it sends the message that it's okay to drink and drive? Or that by selling guns at Wal-Mart and K-Mart (do they still?), the real message is that it's okay to go out and shoot somebody?
Not even close. The sole purpose of the Plan B drug is to allow sex without consequences. Guns aren't supposed to be used to just go out and shoot people and alcohol is never supposed to used when you're driving.
I'm not exactly sure how this drug works so I can't tell you if I agree with availability at all, but I don't have a problem with contraception in general. And for the record I'm pro-gun control and for tighter restrictions for drugs and alcohol.
Posts: 3446 | Registered: Jul 2002
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posted
Lyrhawn, since you can't test drugs on children there's no way to garuantee their safety when used on minors.
Posts: 3446 | Registered: Jul 2002
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with the high incidence of rape and sexual abuse in this country, I think your statement about "sex without consequences" is a bit limited.
I can foresee lots of uses of Plan B by women who would prefer to be sure they did not get pregnant by the man who used them for sex and who might prefer, for a variety of reasons to avoid going to a doctor or the police.
Also, since I'm not prepared to say that society should choose for women when they can and cannot have sex, I'm pretty happy with the idea of effective contraception if they choose to use it rather than deal with the weightier consequences of an unwanted pregnancy.
Plan B is possibly more of a concern because it could result in the failure to implant of an otherwise viable and already fertilized embryo. At least that's my understanding of one of it's possible effects.
But given that I also believe that a woman who would use it would also choose an abortion should be found a week later to be pregnant, I don't actually see that Plan B is a worse option.
Posts: 22497 | Registered: Sep 2000
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posted
If people were really buying Plan B primarily to protect themselves from getting pregnant after they were raped that would be one thing, but I don't buy that for a second.
Posts: 3446 | Registered: Jul 2002
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quote:Lyrhawn, since you can't test drugs on children there's no way to garuantee their safety when used on minors.
Alright, that makes sense, but why then has this never been an issue in the past with the hundreds of other over the counter medications that teenagers are able to obtain? If tests weren't done on those drugs' effects on minors and were still approved for use by minors, then I'm still led only to believe that this is being done for social engineering/political motivations, which I believe the FDA should have no part of.
Posts: 21898 | Registered: Nov 2004
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posted
Able to obtain isn't the same as recommended and the potential side effects if something goes wrong is necessarily the same either. Since with most other OTCs the issue is purely the size of the patient a smaller dose can simply be recommended. Without being an expert on the drug in question, I still think I can make an educated guess that factors other than just size play a role in how it affects the patient.
Personally I get much more worried when the FDA drags their feet approving medications for cancer and other potentially terminal illnesses than when the FDA doesn't move as quickly as they should when dealing with another form of contraception.
Posts: 3446 | Registered: Jul 2002
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posted
Well, first, I doubt there is any political wrangling to be done with cancer medication.
Second, I'm betting there is a lot more testing and clinical trial involved with testing cancer drugs than with contraceptives. Though I could be wrong.
And either way, there's no uproar over any other drug out there, recommended or not, regardless, for over the counter selling to minors, so I don't buy the argument on medical grounds.
Posts: 21898 | Registered: Nov 2004
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posted
You know, I don't see what the problem would be. Lock it up behind the counter and require ID like cigarettes. An overdose of ANY drug can harm you. So can misusing any drug. If pharmacists were responsible for checking ID, they could also be responsible for making sure the patient understands the directions (like when you pick up a prescription.)
quote:Personally I get much more worried when the FDA drags their feet approving medications for cancer and other potentially terminal illnesses than when the FDA doesn't move as quickly as they should when dealing with another form of contraception.
It's not just "another form of contraception"; it's a new concept and would be a godsend for women in many situations I could think of (besides "traditional" rape, what about women who are forced to have unprotected sex by their husbands and don't want any more children? And there are others.)
And often when the FDA "drags its feet" on things like cancer drugs, it's either because A) required testing has not in fact been completed and they're being asked to speed to a decision without following their normal policy or B) they're trying to weigh potential side effects and see if they're really worth putting that drug on the market. We've seen recently what happens when they approve drugs and then later find out that there are unforseen consequences.
Posts: 21182 | Registered: Sep 2004
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quote:You know, I don't see what the problem would be. Lock it up behind the counter and require ID like cigarettes. An overdose of ANY drug can harm you. So can misusing any drug. If pharmacists were responsible for checking ID, they could also be responsible for making sure the patient understands the directions (like when you pick up a prescription.)
This is what I was going to say as well. One might attempt to argue that it's no longer OTC if you have to go to the pharmacist to get it, but since we now have to go to the pharmacist counter to get Sudafed in many of my stores, I don't see the basis for a complaint here. (heck, some of our hme improvement stores are keeping spray paint cans under lock and key in an attempt to prevent purchases large enough to enable gang tagging... so it's not just medications anymore.)
Posts: 4515 | Registered: Jul 2004
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Boon
unregistered
posted
I have to have a prescription to obtain birth control pills. Heck, the pharmacy has to call my doctor if I want more than one month's worth at a time. If Plan B is, as I understand it, a large dose of the same hormones as birth control pills, why shouldn't it also require a prescription?
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posted
I suppose the same arguments could be used for birth control pills. It seems that they would be a lot safer than Plan B, too.
Of course, you usually don't need a prescription for birth control pills in a very short amount of time. Perhaps what we need is a confidential service which is open 24 hours a day and can help women on short notice?
Posts: 3546 | Registered: Jul 2002
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quote:Perhaps what we need is a confidential service which is open 24 hours a day and can help women on short notice?
That'd be great, but it will never happen. Even if a private company did it, like an offshoot of Walgreens of CVS (or whatever pharmacies you have around you) were to provide such a service, Conservatives in Congress would place so much oversight and so many restrictions on them that it would become, in a business sense, impossible to stay afloat. It'd require state or national level funding. And there's no way you'll ever get either for what would, in their minds, amount to secret abortions taking place in pharmacies all over te country.
My wondering, is how much a morning after pill would cost. A disproportional amount of unwanted pregnancies come from the lower class, who might be unable ot afford such a pill. Would insurance cover it? Could it be discounted? If not, one could make the case that the pill really is being targeted towards middle income teenagers. I wonder what the figures are on unwanted pregnancies and what age groups and socioeconomic groups the numbers fall into.
Posts: 21898 | Registered: Nov 2004
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posted
Maybe a hypothetical contraceptive service would actually be this way, but given conservatives' love of deregulation and liberals' distaste for it, and who backs the agencies that regulate to death and who doesn't . . . I think this is just a liberal imagination of what conservatives would do. (Like when liberals imagined that conservatives would leap at a chance for "faith-based funding," and conservatives rejected it.)
To this conservative, contraception does not, in my mind, amount to secret abortion. Again, a liberal imagination of what conservatives think.
But it's possible "conservatives" in Congress would do hyper-regulation of something; they vote for a lot of other anti-conservative things.
Posts: 1877 | Registered: Apr 2005
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quote: Like when liberals imagined that conservatives would leap at a chance for "faith-based funding," and conservatives rejected it
Forgive me, but, isn't the leader of the Conservative movement, that being the President of the United States, the biggest proponent of faith based funding initiatives?
Posts: 21898 | Registered: Nov 2004
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posted
The Washington Post has followed up this story with a report of the resignation of the director of Women's Health programs at the FDA:
quote:Susan F. Wood, assistant FDA commissioner for women's health and director of the Office of Women's Health, said she was leaving her position after five years because Commissioner Lester M. Crawford's announcement Friday amounted to unwarranted interference in agency decision-making.
"I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled," she wrote in an e-mail to her staff and FDA colleagues.
quote:Rather than controlling access to the other ingredients in meth (like anhydrous ammonia) we went after a product used by millions. Why'd we do that?
I think it was simply a case of the FDA being in a position to order recall of sudafed, whereas the Dept. of Ag. would need something more substantial to control the distribution of ammonia. They controlled sudafed because it was under the FDA's purview to do so, with no thought as to whether they should be allowed to do so.
quote:You know, I don't see what the problem would be. Lock it up behind the counter and require ID like cigarettes.
I think the FDA knows that if they mandated this, there'd be a good chance that a lot of pharmacies would ignore the age restriction.
I'm just imagining a tearful sixteen-year-old girl crying to the pharmacist, "It was such a mistake, and if I get pregnant I'll kill myself." And I think a lot of them would distribute the pill to her.
Especially if they don't agree with the FDA age restriction.
Posts: 5462 | Registered: Apr 2005
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quote: I'm just imagining a tearful sixteen-year-old girl crying to the pharmacist, "It was such a mistake, and if I get pregnant I'll kill myself." And I think a lot of them would distribute the pill to her
One of the issues I see is people, especially someone like the 16 year old mentioned above, not taking the pill the morning after, but several months into the pregnancy and taking a massive dose of it. I know this point was mentioned earlier, but if the girl would say that should would kill herself, I am sure she would not be concerned about an overdose. This is one of those very difficult questions to answer. How do we help people who need it, while at the same time prevent people from abusing it? Even if the pharmacy would only give her one pill, or one dose, there is nothing to stop her from going to several pharmacies with the same story. Even at 16, is she really old enough to make this kind of choice? Some may, and some may not. Something else that just came to mind, what if a guy forces or slips a girl this pill? This is a really tough issue
Posts: 1918 | Registered: Mar 2005
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posted
Could anyone explain exactly what the Plan B pill is doing? I've tried to find something on the net, but with so many news about it it's hard to come up with just a description of it. Thanks.
Posts: 4519 | Registered: Sep 2003
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