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FDA should end delays on Plan B sales

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Monday, Aug 07, 2006 - 12:12:58 am CDT

The shameful political games over the Plan B emergency contraceptive are well into their third year, but there is some hope that the bickering over this vital subject may soon be at an end.

It would be folly, however, to assume we’ve reached the endgame. We’ve been led down this road before.

The latest arena is a Senate committee confirmation hearing for now-acting director Dr. Andrew von Eschenbach, nominated to head the Food and Drug Administration.

The FDA, in what is seen by some as a bid to influence von Eschenbach’s nomination process, said it was moving toward endorsing sale of the pill without a prescription for women 18 and older. The desire to keep the drug out of the hands of underage girls is commendable. Surely, a way can be found to do this without keeping Plan B prescription-only for women of all ages and without appearing deliberately obstructionist.

There are still many possibilities that approval could stall. The FDA still wants to have direct talks with Barr Pharmaceuticals Inc., which has already developed a program to restrict sales. But the FDA could find fault with Barr’s plans, and we’d be back at Square One. Or President Bush could push von Eschenbach through via another one of his recess appointments.

Senate Democrats could still put a “hold” on a floor vote to approve a nominee. Sens. Hillary Rodham Clinton, D-N.Y., and Patty Murray, D-Wash., said they would block a floor vote until the FDA made a final decision on the drug’s sale.

Plan B was approved for prescription use in 1999. Since 2003, the Women’s Capital Corp., and then the pharmaceutical company, have sought to sell it over the counter. The pill consists of a high dose of the most common ingredient in regular birth control pills. When taken within 72 hours of unprotected sex, the two-pill series can lower the risk of pregnancy by up to 89 percent.

Barr has gone through all the regulatory hoops with its morning-after anti-pregnancy pill, but the Bush administration seems determined to box it up.

“We all know what’s going on here,” said Sen. Tom Harkin, D-Iowa, a committee member. “This is a disregard for science out of ideological concerns.”

Opponents fear the contraceptive would promote promiscuity. But studies showed that its availability did not lead to an increase in sexual activity. It is sold without a prescription in 45 countries and nine states.

This drug’s effectiveness and safety have been certified again and again by the FDA’s medical staff. The pill prevents fertilization from occurring in the uterus after intercourse if taken within 24 hours, often longer. It is most effective when taken soon after intercourse, the reason its supporters want it available without prescription.

It is estimated that Plan B could prevent up to 1.5 million unintended pregnancies and 600,000 abortions a year in the United States. The evidence of its safety and value is too high to dither any longer.

Enough political tricks and procedural shenanigans. Plan B should be available without a prescription.


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Hemet wrote on August 7, 2006 12:54 am:
" The LJS editorial people seem to be coming of age as a real and professional news source. Well thought our, real and to hell with what the ill informed may think. "

 c.h. wrote on August 7, 2006 5:22 am:
" I don't understand how something this advantageous could be so politcized. What 'ideological concerns'? Surely this is something that both the pro-life and the pro-choice people should be lining up behind. It reduces unwanted pregnancies, and therefore abortions. Absent age-related health problems, I'd like to see it available for all women. All opponents have against it is a 'fear the contraceptive would promote promiscuity'? First of all, AIDS pretty much took care of promiscuity, and for those who remain promiscuous, if fear of death didn't stop them, why would anyone think fear of pregnancy would? Why should we care who sleeps with whom, and how often? If we DO care, should we punish ALL women for the actions of those few? It's ludicrous! This is something that's available already in 45 countries and 9 states! They've noted no increase in sexual activity.(though I shudder that they even checked) The United States has long denied it's terminal patients palative heroin, so much a superior pain manager than morphine that people with relatives in canada, often go there to die, because they fear it's illegal use. We need to cease denying people good medicines because of what we think other people might do with it. I'm all for the FDA ensuring that our drugs are safe. They've said that this is. Quit stalling! "

 Hjalmer wrote on August 7, 2006 6:41 am:
" I can not figure the logic of the right wingers opposition to this option. The best way to avoid the abortions that EVERYONE thinks is a sad choice, is to prevent unwanted pregnancies. If the radical right truly wants to help reduce the number of abortions they have to help us reduce the number of women that are pregnant and desperate to end their pregnancies. The "morning after" pill is one step toward doing that. "

 Amy wrote on August 7, 2006 7:34 am:
" Wow, do some homework. Pro-lifers oppose the morning after pill because it CAUSES a chemical abortion. "

 Jim wrote on August 7, 2006 9:06 am:
" Of course it's logical that someone who truely wants to reduce the number of abortions would support this. But you forget that's really not the true motivation of many right to lifers. The actual motivation is to impose their sexual mores on everyone else. And actually that's not 100% accurate, it's to feel self righteous about trying to impose their sexual mores on everyone else. But they really don't want that to happen, because then they'd have to find something new to feel self righteous about. "

 D.S.B. wrote on August 7, 2006 10:38 am:
" 600,000 abortions a year. The right to lifer's would have these all result in live births. In 10 years, that's 6 million people, roughly the population of New York City. In 20 years, two NYC's, and THEN those people start having kids. Not long before we can't feed or shelter or educate them. This pill does not cause a chemical abortion, it merely prevents a blastocyst from implanting, something, some doctors say, up to 60% of them don't do anyway! Let's look past the end of our noses, folks. Don't follow the path of the right-to-lifers. That way lies disaster. "

 Ryan wrote on August 7, 2006 12:33 pm:
" The public will continue to be largely misinformed if generally respected papers, such as LJS, continue to print statements that are not comprehensively factual. "The pill prevents fertilization from occurring in the uterus after intercourse if taken within 24 hours, often longer." This statement is only partially true, convenient for the obviously slanted author(s). The truth being that if fertilization has already occurred, which is very possible, that this panacea pill will chemically kill this human. Consider how many people alive today have gone through this fragile moment of life, who do not yet have a voice...all of us. Should all people without a voice be arbitrarily disposed of at will? Such as people who are sleeping? Sounds ridiculous, doesn't it? Must a human need be able to verbally say she wants to be alive in order to enjoy the right of life? Or should society give the child time... "

 AntiJim wrote on August 7, 2006 12:47 pm:
" This editorial states incorrectly that Plan B prevents fertilization. It prevents implantation of a fertilized egg. A fertilized egg is a human being at his/her initial stage of development. Plan B, as stated by Amy, causes a chemical abortion. Education continues to be vital. Young women and men need to be provided ALL the facts (correctly) and not just partial truths as expressed by this LJS editorial. Why didn't LJS print a counter point to this awe inspiring editorial? Isn't presenting just one side of an issue, even if a LJS sponsored editorial, woefully biased? Print both sides, please! "

 Glenn wrote on August 7, 2006 1:05 pm:
" I doubt any of us have all the facts but the only real concern I have either way is this. The FDA is compelled to require a prescription for birth control however some feel it's okay to offer these same drugs in much higher doseage without medical oversight. Something doesn't add up with either requiring a prescription for birth control or offering plan B with out one. "

 Ray Parker wrote on August 7, 2006 1:16 pm:
" It is a proven fact that easy access to the Plan B morning-after abortifacient will not reduce the number of surgical abortions, but will dramatically increase the venereal disease rate. It is a dangerous overdose of a contraceptive drug which, in normal doses, REQUIRES A PRESCRIPTION. "

 Sylvia wrote on August 7, 2006 1:21 pm:
" If a woman is responsible enough to know when her first or even second line of birth control has failed, she should be able to get access to a third line of control. In the long run it will save her time, money, employer work hours, worry, and emotional distress. The FDA, sans politics, would approve it for OVER THE COUNTER use, but the politicians keep this from happening despite the science. Worried about kids having it? Attach it to a bottle of wine or anti-histamines. There are procedures for that already in every market that can sell those items. As a small business owner, I will be glad when I have this immediate option available for myself and my daughters. "

 KellyJo wrote on August 7, 2006 1:21 pm:
" I couldn't agree more with Jim and D.S.B. Right-to-lifers are all about trying to tell us how we should live our lives. They may SAY they don't want an unborn child to die, but where are they when these children are born and are then abused, neglected, killed? Are they willing to take in, pay for, and raise the 600,000 children? Of course not. They only want to feel superior and shove their self-righteous morals down everyone's throats. This Plan B pill is the best of both worlds for both sides of the argument. The fact that this issue is still stalled in Congress is yet another shining example of our government at its worst. "

 Justin wrote on August 7, 2006 1:24 pm:
" Did you pro-lifers somehow MISS the part about it preventing 600,000 abortions per YEAR? That's 6 million aboetions in just 10 rears. Will you not be happy until there are so many babies born that they all will starve to death because there's too many of them?! "

 Hey wrote on August 7, 2006 3:39 pm:
" Until you get your Plan-B wonder drug... maybe you can just keep your pants pulled up a little more often. That used to be called personal responsibility. It used to be called Self-Control. Perhaps Plan-A is the better way to go. "

 Jim wrote on August 7, 2006 6:20 pm:
" If you really want to prevent abortions you'll advocate widespread distribution of birth control. Vending machines with condoms and birth control pills in the high schools. In fact, make them both available to the general public for free, funded by tax increases. You would advocate complete and honest sex education in our schools (totally abandoning an abstinince only position). You would advocate another tax increase to provide free birth control to third world countries. Because if you truely believe that abortion is the 'holocaust of our generation' then you would do everything in your power to reduce the frequency of it, and doing these things would reduce it rapidly and dramatically. It's really pretty simple - if you truely do want to reduce abortions. "

 teacher wrote on August 7, 2006 6:37 pm:
" Amen, jim! especially the part about complete and true sex education. To have abstinence-only sex-ed mandated to us,by the federal government, when sex can kill, is the most appalling injustice to our children. Condoms should be in vending machines in schools, just like tampons. To risk long-term disease, or even death from an impulsive moment (teens aren't widely known for their impulse control) because some fear 'sending the wrong message' can have horrific consequences. How about sending teens the message, "we value you, we care enough about your health, and your life, to be honest with you, and protect you" "

 Pah wrote on August 7, 2006 8:42 pm:
" Actually... abstinence education might have a real impact, if teachers and generally all adults would stop telling kids that 'we know you're going to have sex anyway'. How about a united voice... please don't have sex. It is something wonderful, but it is for a later time. Please don't swallow the hyper-media storm that everything revolves around sex. Life doesn't have to revolve around sex. You know... in the olden days, some kids had sex, but most didn't. There was a general attitude in society, that you should not have sex until you are married. Most kids held to that; and a very few failed to resist. Today, it is completely opposite. The kids that choose not to have sex are ostrisized; considered some kind of religious moral freaks of nature. Society is doing this to our kids... not the federal government. "

 AntiJim wrote on August 7, 2006 9:25 pm:
" Careful Pah, you are coming dangerously close to promoting the only lifestyle that liberals truly oppose. Personal responsibility? Won't the government take care of us? Won't they subsidize the way I want to live? "

 both wrote on August 7, 2006 9:46 pm:
" Pah, I'm not saying abstinence education is bad. All the things you say about it are valid. I'm saying that abstinence ONLY is bad. We need to educate all the kids, so those 'some kids' who do have sex, know how to protect themselves and their partners. "

 Anti-AntiJim wrote on August 8, 2006 7:06 am:
" On the contrary, the liberals promote personal responsibility, the conservatives promote "do it my way or else". What ever happened about freedom of choice and personal choice? The neo-cons will have non of that! It is their way or the by-way. "

 Jill wrote on August 8, 2006 8:57 am:
" I don't think this article necessitates a conversation on lifestyle choices. The availability of Plan B won't change anyone's decision to have sex anymore than the availability of condoms. It is ridiculous to suggest that more people will have unprotected sex just because this product is on the market. This is just another way for people to take responsibility for themselves. They realize they are at risk for an unwanted pregnancy, and they can take personal responsibility for their actions before they take on the vast and far more important responsibility of raising another human being. The fact that they personally recognize they are not at a place in their lives to raise a child is personal responsibility. Shaking your finger at them and saying 'bad' doesn't seem to have any effect. I also don't have a problem with encouraging teens to wait to have sex. Teens should be encouraged to make responsible and informed decisions in everything they do. However, at some point, teens become adults. How will these adults be informed about birth control, STDs, and pregnancy if we don't teach them? Everyone on this comment board seems to know all about these topics, maybe because of public education, maybe your parents, maybe your church, maybe your friends, maybe you taught yourself. Regardless, we can't rely on parents or church, and we don't want to rely on friends, so public schools are the only place we can guarantee to provide teens with complete and accurate information so they can make fully informed decisions as 16 year olds, and as 26 year olds. We do our children a disservice by witholding information from them that could be crutial to their health. Lets provide everyone with complete and correct information, provide them with positive role models at every chance we have, and lets provide everyone with a last resort so they can take responsibility for their mistakes. "

 Medical Provider wrote on August 8, 2006 11:10 am:
" People this should not be OTC. (over the counter). It needs to remain Rx only. Normal birth control pills are Rx only and so should this. I don't prescribe the "morning after pill" because of my personal choice, but I do have partners that do. If that is something the patient wants then I direct them to my partners. Let us remember what this is though, contraceptative means prevention of conception, this is not that. It is an abortive measure. Please understand that with any medication it has side affects. This is not tylenol, which if taken in large doses will end your life as well. It needs to remain as a prescriptive drug. Not a control issue but a safety issue. "

 Kelly wrote on August 8, 2006 2:14 pm:
" Medical Provider--you state this is not a control issue, and then make arguments based on your personal opinion and not facts. Everything has side effects. My understanding is that it makes more sense to have normal BC be prescription only because of the wide variety of products and the different effects each can have. Women with extra-heavy periods are prescribed one kind, women with irregular cycles another, women with acne problems a different one yet. Understandably people need help sorting through options that best solve their problems. If one BC pill isn't giving the desired result, the Dr. prescribes a different one. As far as I know, PLAN B is the only OTC emergency contraceptive choice being considered. Women don't need advice as to whether this will cure their symptoms, they know if they are at risk of being pregnant. Dangerous substances are sold all the time: alcohol, cigarettes, superglue, knives, rat poison, sleeping pills, not to mention thousands of kinds of OTC drugs that people voluntarily ingest. People (not just women) make decisions about what they are going to put into their body every day. Women are perfectly capable of making these decisions as well. If you have personal feelings against PLAN B, never purchase it and discourage your friends and family members from doing so as well, but please don't use 'safely' as a guise for restrictions founded on your personal opinion. "

 Yes wrote on August 8, 2006 2:48 pm:
" The availablity of "the way out pill" does change attitudes about having or not having sex. If there is a preconceived notion, that there are no consequences to having sex, then sex will be had, and lots of it. If our fingers didn't burn when we touched the hot stove burner... it might be lots of fun to touch the pretty red circle thing. But it does burn our fingers, and so we don't touch it. That is just plain human nature. "

 no wrote on August 8, 2006 4:31 pm:
" Yes, where have you been? AIDS pretty much took care of the idea that there are no consequences to having sex! Your comment is pretty much indicative of the whole problem with anti-choice people. You want to impose your morals on the world. Most of us don't think sex, in and of itself, is bad. Some of us even like it! "

 Duh wrote on August 8, 2006 6:57 pm:
" Give me a break 'no'. We don't think sex 'in and of itself' is bad either. We just think that when people started breeding like bunny rabbits, it was time to start saying something. Act like responsible adults, not hormone ravaged rabbitoids. That's all. "

 logic? wrote on August 8, 2006 10:43 pm:
" So the logic here is that if we prevent everyone from having access to a 'back up' or 'way out' people will have to make a choice between being 'responsible and moral' by not having sex/accidents and being 'irresponsible and immoral' and engaging in risky behavior in disregard of the consequences. This reasoning results in only 'irresponsible and immoral' people even needing plan b, so only 'irresponsible and immoral' people will be pregnant when they don't want to be. This results in the 'consequence' of providing for, raising, and morally educating another human being who will be a member of society. Now we have the most 'irresponsible and immoral' people in society taking care of an unwanted baby when they have shown, by your standards, that they cannot take care of themselves and make responsible decisions for their own life. Until you can force everyone to 'act like responsible adults,' don't even pretend you can force anyone to be a responsible parent. CHIDLREN SHOULD NOT BE USED AS A PUNNISHMENT! "

 connie wrote on August 9, 2006 7:10 am:
" duh, 'no' was on YOUR side. 'Plan B' is meant to help people stop breeding like rabbits and have access to help. It was 'yes' who thought pregnancy should be a consequence. I echo 'logic' here. Children should never be used as a punishment, or viewed as a consequence of poor behavior!!! Oh yeah, anyone know how to stop this irresonsible and dangerous 'abstinence only' travesty? "

 Comedic Relief wrote on August 9, 2006 8:35 am:
" Listening to you pseudo intellectuals spout off this topic has given me the best laugh I've had in awhile, keep your narrow minds pointed. "

 Hjalmer wrote on August 9, 2006 8:59 am:
" If we really want to reduce the number of abortions, comprehensive sex education in schools is the answer. Check out the experience of Western Europe. Despite the fact they have comprehensive sex education for their children starting when they are very young, and despite the fact they have a very permissive society, young girls become sexual active a full two years later than in the United States. In addition, unwanted pregancies are rare compared to the United States and abortions are even more rare. You know, our children really aren't like dogs and they don't behave like dogs. If we take the time to educate and empower our children they'll make much better choice than if we try to keep them ignorant. "

 Pah wrote on August 9, 2006 10:13 am:
" We don't want ignorant, Hmalmer... we want children to understand sexuality, reproduction, AND have it drilled into their heads that they should remain celebate until they are in a stable committed marriage, where the results of procreation are fully expected, honored, and joyful. What we want to stop, is the drilling into our children's heads that we know you can't help yourselves, so here is a goodie bag filled with funny looking latex balloons, hormone tablets, and emergency kill the little bugger pills. "

 Whitney wrote on August 9, 2006 10:44 am:
" Hjalmer, Amen, Amen, Amen! As a mother, I've protested mandated abstinence-only sex-ed to anyone and everyone who could possibly be a voice in changing it. I invite anyone who has kids, or who cares about kids, to join me. "

 action wrote on August 9, 2006 11:30 am:
" Pah, if you want to drill messages into teens' heads, that is fine, but that should then be a higher priority than removing contraceptives from the market. Get your message across BEFORE you try to take away the options. Trying to take away choices before you have an effective prevention system in place does a disservice to all involved. That being said, it is possible to inform everyone, send a positive message AND have last resort options available. Regardless of what people are taught or practice, the fact remains that sometimes things don't go the way you intend. Everyone deserves to make a decision for themselves about how they will handle it. It is possible to have plan b available without handing it out in your elusive 'goodie bag.' Your last sentance echos 'logic's' lament--you are using unplanned pregnancy and child-rearing as a consequence or deserved punishment for children who weren't responsible to begin with. "

 Steven wrote on August 9, 2006 11:45 am:
" The morning after pill doesn't reduce the number of abortions and, in Scotland, where it was made available over the counter in 1999, officials recently announced that abortions there are at their highest points on record. As surprising as it may seem to proponents of Plan B, a 2005 study co-authored by a Planned Parenthood doctor in the Journal of the American Medical Association showed that having Plan B on hand did nothing to reduce pregnancy rates compared to those who obtained the drug from a pharmacy. For more info, see http://www.LifeNews.com "

 Ryan wrote on August 10, 2006 11:56 am:
" Medical Provider is right. Kelly's logic is way off. She would have you believe Px BC pills, which are a lower dose of hormones, need to be Px only because there are so many different variables amongst women to consider. But that the MAP, which is a higher dose of hormones (and inarguably more dangerous), should be OTC because it's "the only OTC emergency contraceptive choice being considered". Ohmygosh, I hope she doesn't become a doctor. Just because they haven't come up with multilple MAPs, doesn't even come close to meaning that it is automatically safe for all ladies. Simplistic logic, backed by strong emotion, is what drives so much of the Left's argument. It is disheartening to think that so many people in this country, which was built on courage and sacrifice, are willing to sell society short and take the easy way out. Medical Provider wants to err on the side of safety...as a health professional should. "

 Hjalmer wrote on August 11, 2006 6:15 am:
" Pah, who said this was only for children? I know that I've read that something in excess of 50% of women that sought abortions had used birth control, but had used it ineffectively. They either weren't taking it effectively, or regularly, or were not using birth control at that point in their life. "Oh, just this one time won't matter" right? That kind of flawed thinking isn't the sole province of children. Big chunks of our society spend large parts of their lives unmarried. Many never marry. Many marriages fail with long periods between marriages. For a moment leave aside your personnal values, do you seriously expect this mass of single people to remain celebate outside of a committed marriage? Even a selected group like the Catholic clergy has a tough time sticking to that. "

 Pah wrote on August 11, 2006 8:52 am:
" You are right Hjalmer. The question then is, do we put tiny humans on the chopping block so as to not inconvenience the non-celibate? What a price it is, that society finds affordable. The answer is... put the consequences back into the equation. It might then be easier to remember to use protection, or to pass on that quickie. It is not "punishment" as some will accuse; rather, it is simply the real, natural consequences of a promiscuous lifestyle, which cannot be overcome without slaughtering the unborn. "

 Hjalmer wrote on August 12, 2006 7:00 am:
" Consequences back in the equation? As a father of three adopted children, children deserve a better start than to be the unwanted consequence of their parents' irresponsibility. Being a successful parent is tough enough when you want the job. Forcing someone that REALLY doesn't want the job to be a good parent doesn't and hasn't worked. If you think that the worst thing that can happen to zygote is to be unable to implant in the uterus, you don't know much about Nebraska's foster care system. "

 jads wrote on August 13, 2006 1:40 pm:
" With all that has been said so far in these comments, there has not been any proponent of the birth control pill who has effectively discussed the fact that a fertilized egg dies, due to the Plan B birth control pill. In fact, I've noticed how all proponents of the pill have dogged the issue of the destruction of life. Until an acknowledgement can be made of the destruction of life because of the pill, there is no argument. "

 Billie wrote on August 13, 2006 4:05 pm:
" jads--I do not address your 'destruction of life' issue because I believe that when a fertilized egg implants in my uterus, it is exactly that--a fertilized egg implanted in my uterus. It is not a person, or a baby, or a human. It is a part of my uterus. If it is so lucky to implant there to begin with and not just exit my body with every other egg. Until an acknowlegement can be made that you are not destructing anything that is something other than a part of me, there is no argument. "

 Kelly wrote on August 13, 2006 4:48 pm:
" My point was completely taken out of context. My point is that plan b is a medicine that any one person will rarely use in her life, while birth control pills are taken every single day, possibly for many years, and become part of a routine. Doctors prescribe birth control for women for dozens of reasons, many of which have nothing to do with preventing pregnancy, however these pills are not marketed as 'period regulators' or 'acne reducers.' Some birth control pills help acne. Imagine if we sold the pills over the counter for the purpose of clearing acne and the inability to get pregnant was the result. People would be outraged. Likewise, if there is a whole shelf of birth control pills and someone needs to find one they can take every day for a year, they may need some guidance in picking one with limited side effects. If someone believes their birth control failed, they only need one dose to serve one specific purpose. Aside from general side effects, I was not discussing major health risks to women. As far as that goes, plan b is any more dangerous that many other drugs available OTC. Before everyone jumps on that, I am aware there have been a few well-publicized deaths over the past few years, however as with any medication you put into your body, there are risks involved. The controversial nature of this particular medication seems to make people go into a frenzy over every instance. People will scream and point fingers when a death occurs as a result of an emergency contraceptive, however no one blinks an eye or demands closer monitoring of other OTC medicines (ibuprofen, acetaminophen, sleeping pills, weightloss medicine) which are responsible for thousands of deaths and even more overdoses each year. Death is very serious, and medications that provide a high risk of death to people with certain conditions should be prescription-only and well monitored, but there are risks associated with everything, and we must decide what level of risk we are willing to accept in exchange for improved accessability and cost. With a product that is not used very often in one dose at a time and provides a wanted result to the person taking it, I am willing to accept a low risk of serious complications, provided the warning is clearly printed on the container, as it is with every other OTC medication. I believe that the only real argument that can be held on the availability of plan b is the actual risks to the woman taking the pills. Everything else is your personal opinion, which should not be used to determine medical policies for the rest of the country. "

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