FDA

Back Up Your Birth Control Backup Day

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Submitted by Heather Corinna on Tue, 2012-03-27 18:34

from http://ecequalsbc.tumblr.com/from http://ecequalsbc.tumblr.com/Yeah, we meant to say that. Boy do we wish we didn't.

Here's the spiel: it's Back Up Your Birth Control Day today, but as you may have heard, or personally experienced, here in the states, we're still having a lot of trouble with pharmacists refusing over-the-counter Plan B (emergency contraception, the morning-after-pill, or whatever you like to call it), for a whole of reasons, including because of age, even though most of those asking for or about it are of legal age to get it over-the-counter, and without a prescription. We knew that was happening already, but that recent covert study linked there brought it more to light and gave this some more (very needed) attention.

We understand that dealing with being refused something when you're likely already feeling panicked, and also asking for something pretty private without much, if any privacy, can make dealing with refusals even more hard and maddening than they already are.

We also know that in that position, sometimes it can be hard to speak up for yourself, especially if you feel judged because of being a young person who had any kind of sex in the first place (or were assaulted and assumptions are being made about you and sex), and a pharmacist is speaking or acting authoritatively, even while they're talking out of their bottoms because they just don't know the legal age or they're knowingly deceiving you because they don't want to dispense it and are just in the mood for some super-fun lording-power-over-young-people that day.

But you've got rights, for crying out loud. If you're of legal age to get emergency contraception over the counter, ayou cannot be lawfully refused on the basis of age.

So, we thought we'd make this a bit easier for you to deal with if it happens, and to prepare yourself for, just in case.

Attached at the end of this entry is a PDF file you can print as a handy helper.  It gives you four fold-over copies to cut down the dotted line, then fold in half. One can fit neatly -- and, given the blank backside, privately -- in your wallet. Since one page prints four, pass the other three (or more!) out to friends who might need it, too.

On each little sheet, the left side shows the law right now around age and the right side says what you can and will do if refused EC. You can use it to read out loud, or even just slide it over to the pharmacist doing the refusing without saying a word, if you like. They may well change their mind about refusing you right there and then once you do that.

But if they still refuse to give it to you based, then you also have all the steps about your next steps right in the palm of your hand. You can find your state pharmacy board and contacts for the given pharmacy's higher-ups just by using a search engine.

The text of this printable "Pardon me, but hell no," reads:

Over the counter Plan B, Plan B One Step, and their generic versions are approved to allow OTC availability of these products for consumers 17 years and older. Plan B, Plan B One Step, and their generic versions remain available by prescription only for women 16 years and younger. - U.S. Food and Drug Administration, last updated 12/16/2011, with a number you or the pharmacist could call the FDA with, and that's 1-888-INFO-FDA.

Besides that text is text that makes clear what you will do if refused, most of which comes from the National Women's Law Center very helpful page on this issue, and that is:

If I am refused Plan B, I will:
• File a compliant with my state's pharmacy board to seek sanctions against this pharmacist or pharmacy
• Communicate my story to the press.
• Alert this pharmacy's corporate headquarters
• Contact my ACLU affiliate (http://www.aclu.org/reproductive-freedom will allow you to find that affiliate)
• Contact the national Women's Law Center (which you can do regarding this issue by calling 1-866-PILL-4_US or emailing info@nwlc.org)

Don't forget that one thing you, friends or partners can always do to have BC backup when you need it is to get Plan B in advance when you have the chance to get it: that way you can avoid not just possible refusals, but avoid having to run around if and when the clock is ticking.  If you might ever need any -- read: you might ever be at risk of pregnancy -- and you don't have it, next time you're at a pharmacy and don't need it can be a very good time to pick a pack up. Also, don't forget that a lot of state health departments, Planned Parenthood branches and other sexual health clinics often dispense it themselves for cheaper than you can often get it at pharmacies, too.


Please Speak Up About the Plan B Decision!

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Submitted by Heather Corinna on Wed, 2011-12-07 14:54

It was probably obvious yesterday that we earnestly thought the FDA might finally turn around a longtime decision, one largely against all advice, information and recommendations from sexual, reproductive and adolescent health and rights experts and advocates, when it came to unfounded restrictions long put on teen access to Plan B.

And that was going to actually happen. The FDA was on board this time around and made the decision to ditch those restrictions. People under 17 were finally going to have the same kind of access to a safe, important kind of contraception those over 17 had, a kind of access there is simply no sound reason to restrict.

And yet.

In what Jodi Jacobson of RH Reality Check so rightfully said can, "only be called an astounding move by an Administration that pledged on inauguration day that medical and health decisions would be based on fact not ideology and for which women are a major constituency, today Kathleen Sebelius, Secretary of the Department of Health and Human Services (HHS) overruled a much-awaited decision by the U.S. Food and Drug Administration (FDA) to make emergency contraception (EC) available over-the-counter (OTC) to women of all ages."

I don't think we can express enough how tremendously and deeply frustrated and infuriated we are here that our optimism was in vain and was so outrageously gutted.

You can read more about it here, here and here and see the memorandum from Kathleen Sebelius here.

If you're like many of our readers and Facebook fans, reading those things will leave you feeling just as angry as we feel about it, if not more so.

It's so tremendously important your frustrations and opposition be heard (perhaps particularly by an administration which rallied youth for their support in getting elected and were so greatly benefitted when young people stood up for them).

It's so tremendously important that your requests for rights like these be heard. And that the incredibly sound, sage things you say like this from reader Arai, "These politicians really need to get on the same CENTURY as the one young people live. All the questioning for contraceptives, abortion rights, gay marriage are real in today's society," or this from reader Katrina, "Politicians on both sides of the aisle reach unheard of levels of cluelessness when it comes to youth reproductive rights and needs," are heard and seen. It is, of course just as important that they are also very thoughtfully and with great intention considered in choices like this, but we can't help much with that part, save continuing to say things like that and continuing to be ardent supporters of youth rights, including reproductive rights.

But what we can certainly help with is to provide at least one place where you can speak your mind about this and be seen and heard, and then take those comments and get more eyes on them from there.

Please leave your comments here about this decision if you are unhappy with it. Please pitch in to help add your voice to other youth voices about this issue if you want to do one of the most basic things you can, the most important things you can, to work towards a different, better, fairer, outcome.

Like we told one of our readers today when she asked why young people should have to ask, beg even, for rights you should have in the first place, the only answer we have is that you shouldn't. But just like other groups have had to voice a strong desire for rights they never should have -- like women and people of color seeking the right to vote, people of color seeking the same essential useful rights white people had, LGBT people asking for the same rights, freedoms and protections cisgender or straight people have -- you've got to keep doing the same with rights like this if you want them.

You shouldn't have to: you absolutely shouldn't have to. But, for now, you do.

Speak your mind: we want to hear you and other people, including this administration -- whether you're a citizen or not -- need to start hearing you. And listening.

P.S.: Would you rather blog about it in a different place? If you do, leave a link!

P.P.S.: The Change.org petition in protest of Secretary Sebelius' action is here.


Ready for arguments about increasing your access to Plan B? We can help.

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Submitted by Heather Corinna on Tue, 2011-12-06 16:45

You may have heard that the FDA may finally remove age restrictions for the morning-after emergency contraception pill in the United States. If you've heard that, you may have started to hear some panic or fear-factoring, not just gratitude and relief.

Currently, in the United States, someone must be over the age of 17 in order to get Plan B at a pharmacy without a prescription. Until two years ago, the age limit was 18. It's still kept behind the pharmacy counter for people of all ages, but those over 17 do not need a prescription from a doctor or a clinic to purchase it.

For a long time now, organizations like ours and many, many other reproductive choice, justice and health organizations, have been lobbying to remove that age restriction, something other nations -- like Canada, Australia, Denmark, Norway, Sweden, Israel and others -- do not apply; a restriction which has never been supported by sound health data. The restriction per age has long been about politics, not health.

In fact, a medical council formed expressly to inform the FDA about Plan B in 2003 recommended it be provided without prescription regardless of age then, a recommendation the FDA did not follow. More than one staff member at the FDA during the years this has been an issue, including the highly dedicated Susan Wood, resigned in protest of decisions about Plan B access and the political motives for those decisions, which stood counter to sound medical information, what the basis of FDA decisions are supposed to be about.

We feel, like so many other sexual health and adolescent health organizations feel, like you might yourself, that young people should have the same rights with their reproductive choices that those over the age of majority do, including the ability to access safe contraceptive methods the same way as those over the age of majority do. We feel that decisions for all citizens like this need to be centered on credible health information, not political or personal agendas or religious beliefs.

Given this possible sea change, you may find yourself, not unlike some former members of the FDA, having discussions or heated arguments about this with people who really do not get it for a while, and in those, you're probably going to face a serious lack of facts. In case you need them, here's a quick and dirty roundup of some typically uninformed statements with some factual information and context to counter them with.

But Plan B is so unsafe! It's like a GIANT dose of birth control pills!

A lot of over the counter medications, also without age restrictions are not only dangerous, but far more associated with serious health risks.

For instance, you can get all of the following over the counter here in the U.S., none of which have any age restrictions (links are to informational listings about them, including health risks): ibuprofen, acetaminophen, cough syrups or cold medications which contain dextromethorphan or pseudoephedrine, sleeping pills or energy drinks. Heck, you can get candy bars within reach even if you are still only crawling around in footie pajamas, but we don't hear people talking about putting them behind the counter for the safety of diabetic kids.

Plan B is a medication just as safe or safer than some of those things, especially when those things aren't used as directed, which happens a lot, no matter how young or old people are. No deaths have been linked to Plan B, and we can't say that about any of the other things I put on that list above.

It's also not quite right to say that it's a "giant dose of birth control pills."

Most people who use the pill use combined oral contraceptives: a combination of a synthetic estrogen and a synthetic progestin. And while both of those things carry potential health risks, especially for people who have health or lifestyle issues that heighten those risks, the larger risks tend to lie with the estrogens or the combination of estrogen and progestin. Plan B does not contain any estrogen, only levonorgestrel, a progestin. That matters and makes it tough to compare to the most common daily-use oral contraceptives. That's also some of why reputable medical organizations assert that emergency contraceptive pills are usually safe even for people for whom regular contraceptive pills are unsafe. The World Health Organization lists no medical condition for which the risks of emergency contraceptive pills outweigh the benefits.

Too, people who use either combined birth control pills or minipills tend to use them for longer than one or two days like with emergency contraceptive pills, but instead will take a pill every day for weeks, months, years or decades, depending on how long they use them for. Very few people will start using birth control pills and only take two out of a pack.

Most oral contraceptives have 100 to 150 micrograms of levonorgestrel per pill; emergency contraceptive pills contain either two two 750 microgram levonorgestrel pills to be taken 12 hours apart (or together: taking them apart is mostly about reducing the chance of feeling nauseated) or one 1500 microgram pill, to be taken 12 hours apart. Almost everyone who uses a birth control pill for more than a week or two is taking in as much of the hormone in Plan B or, and most typically, far more. And these medications aren't like a sleeping pill or even an advil when it comes to overdose, if that concerns someone about the amount of hormone in Plan B. Not only do we know this is a safe amount to be used as directed, "overdosing" with oral contraceptives does not present the kinds of dangers we see with other kinds of medications. It might also help to take a look at the facts about frequent use of emergency contraception: in a word, we have no evidence so far, after more than decade of research, that has found any more or different risks than ongoing, proper use of other hormonal contraceptives.

Let's not forget that pregnancy can be one of the riskiest things there is when it comes to people's health. Preventing pregnancy with a safe medication like Plan B poses far less risk to someone's health, especially a young teen's health, than a pregnancy does.

But, but... it is SO DANGEROUS for TEENS!

But, but... it isn't. Not that anyone has discovered so far with many years of scientific study, anyhow. There has NEVER been broad medical or scientific support for the decision to require a prescription for minors, but not older people. It's been the other way around: most healthcare professionals and medical organizations, like the World Health Organization, the American Academy of Pediatrics, the American Medical Association and the American College of Obstetricians & Gynecologists, as well as, again, many doctors at the FDA, have objected to these age restrictions. The people who tend to oppose it most are people like this. (Note: that link is to an anti-choice site, the American Life League, which is hopefully obvious from the first sentence, but may become more so by the total lack of contextualization with the information given there, such as a lack of mention that all the risks they list for the MAP exist with a pregnancy. And maybe when reading their website.)

So much of what people know and have heard about emergency contraception has been informed and greatly influenced by people and organizations who are anti-choice, and who oppose Plan B and often other kinds of contraception, not because of concerns for anyone's health, but because of their political agendas to limit the control people -- most commonly women -- have over their bodies and reproduction.

Again, know what's dangerous, sometimes truly, earnestly dangerous? Pregnancy. Now, that doesn't mean people need to be afraid of pregnancy or that we're saying people who want to become pregnant shouldn't make that choice if it's a wanted choice. But there's a reason why maternal mortality rates are so high in places where pregnant people can't get sound, consistent care during pregnancy, labor and deliver from healthcare providers, including educated midwives. That's because pregnancy is dangerous. Preventing pregnancy with safe, studied contraceptives is always statistically safer than becoming pregnant. So, if someone wants to flip their lid about how dangerous contraceptives like Plan B are, they better at least be pulling out all the same stops and more about how potentially dangerous being pregnant and giving birth can be, too.

And even though legal abortion is also very safe, and in the first trimester, safer than a full-term pregnancy, emergency contraception is safer than abortion, too.

Some people have concerns that teens will not be able to understand how to use EC properly without getting a prescription from a doctor. While it doesn't make much sense to have that concern about EC and not all the other medications a young person can currently get over the counter, some studies have found that concern also is not sound. "Two studies were published in 2009 regarding emergency contraceptive label comprehension for teens. Raymond et al. found that 79% or more of adolescents aged 12-17 correctly understood six key concepts found in labeling: 1) EC prevents pregnancy after unprotected sex 2) it should be taken as soon as possible 3) it should be taken within 72 hours 4) it should not replace regular contraception 5) it does not protect against sexually transmitted infections (STIs) 6) it should not be used by women who are already pregnant." (The Reproductive Health Technologies Project, Tough Questions and Answers about Adolescents and Over-the-Counter Emergency Contraception, 2009) By all means, patient and consumer literacy is always something to be concerned with, but we have no reason to believe this is a greater concern with teens regarding Plan B than it is with people of all ages.

It might also help to know that there are already some contraceptive methods as available to teens as to those over the age of majority which we know or suspect may pose different or greater risks for them, like Depo-Provera, which may present risks around bone density for younger teens. And young people should be informed by their doctors or pharmacists of any risks these or other medications or devices present to them based on age, when there are any, just like people should be informed when older age increases a risk, or when a given health condition or lifestyle issue may increase risks.

And if there were different or greater risks with Plan B for young people than those one, three or ten years older, those same standards should be applied and, you can be certain, would be applies. Thing is, based on all the study of these medications so far, we don't have any data to suggest the risks are different or greater for those under 17.

I am not okay with teenagers being able to give themselves an abortion by just walking all willy-nilly into a pharmacy.

Even as a strongly pro-choice person, I don't know if I'd feel comfortable with that, either. I am, however, a fan of walking willy-nilly. It's much more fun than just plain old walking, that's for sure.

But that's moot, since no one of any age can give themselves an abortion by just walking into a pharmacy and getting Plan B, including in places where people of every age can access emergency contraception without a prescription. That's because you can't use emergency contraception to terminate pregnancy.

A lot of people -- some out of ignorance, some who know better but know how easy it is to obscure the facts by just muttering the A-word -- have the odd idea that emergency contraceptive pills and a medical abortion, or "the abortion pill" are the same thing. They're not. Plan B and other emergency contraception not only is a very different medication, it does very different things. Even if someone wanted to terminate a pregnancy with Plan B, this medication can't do that: it lacks that capacity.

You can get information on the "abortion pill" -- a bit of a misnomer by itself, since medical abortion involves two medications, not just one -- here.

But more people will have sex without using birth control if they can just get EC easily.

Emergency contraception has the word contraception in it because that is what it is: it, like other methods, is contraception. Is it as effective as several other methods? Nope. It's also more expensive, too, especially if people are using it often.

I'm not sure why anyone is this concerned about people choosing this method of contraception rather than others by this token, but for those who are, so far, we also don't have any data that shows that when EC is made more available, including giving minors the same access those older have, that there's any basis for that concern. As reported by the Alan Guttmacher Institute years ago, providing adolescents with advance doses of emergency contraception neither increases their likelihood of having unprotected sex nor negatively affects their use of condoms or hormonal contraceptives.

Perhaps more to the point, if one is worried about people not using contraception, then it's tough to figure how it makes sense to limit their access to contraception.

Want more information about emergency contraception, including teen health concerns? Check out these links:

If and when you get tired or arguing with someone about this who just will not let go of the non-facts, do yourself a favor and just print them out, pass them on, and give yourself a breather. Bashing one's head into walls is something we know isn't healthy. :) If, on the other hand, like some of us (coughcough) you seem to have dedicated much of your life to arguments like this and you find what we gave you here isn't enough? Leave a comment with an aspect or issue you want more information about or help voicing. We're glad to help you out.


FDA Panel Unanimously Approves the FC2 Female Condom

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Submitted by Jill on Tue, 2008-12-16 14:51

An FDA advisory panel unanimously approved the FC2 female condom. The FC2 is very similar to the current version of the female condom and is in fact intended to replace it. The primary difference is the FC2 is made of nitrile instead of polyurethane, making it cheaper to manufacture. As that one of the primary barriers preventing women from using female condoms is cost, this is excellent news.


The Morning After the Morning After (or, what the FDA decision about Plan B means to you)

The morning after pill is now legal in the U.S. for over-the counter use, without a prescription, for those over 18. But what does that mean to you?

...and the hits just keep on coming!

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Submitted by Heather Corinna on Tue, 2005-09-20 17:00

So, Susan Wood, director of the FDA


Speak Up for Over-the-Counter Emergency Contraception NOW!

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Submitted by Heather Corinna on Mon, 2005-09-12 17:00

The FDA panel overseeing the issue of making EC over the counter has not only once stalled on a ruling because they have requested "public comment" before doing so, they have now stated they need even MORE public comment. Bear in mind that, to my knowledge, NO drug before has EVER been required a "public comment" period, and since it is the FDA's job to only consider medical and health safety issues, public sentiment that is NOT about those issues should have no bearing on their decisions.


The FDA thinks you're stupid.

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Submitted by Heather Corinna on Thu, 2005-08-25 17:00

Not only has the FDA yet AGAIN delayed a ruling on over-the-counter access for emergency contraception with a completely bogus excuse, they've made clear that they have NO plans to make it OTC for one of the groups which need it over the counter the most: young adult women.

From National Organization for Women President Kim Gandy:

The National Organization for Women calls on women's health advocates to join in a National Day of Action on Tuesday, August 30, protesting the decision by the Food and Drug Administration (FDA) regarding emergency contraception (EC).


Medicare to Cover Viagra, While Bush Administration Continues to Block Women's Access to Morning-After Pill

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Submitted by Heather Corinna on Mon, 2005-02-14 17:00

To: National Desk
Contact: Ted Miller of NARAL Pro-Choice America, 202-973-3032

WASHINGTON, Feb. 1 /U.S. Newswire/ -- NARAL Pro-Choice America, the nation's leading advocate for personal privacy and a woman's right to choose, said Americans are outraged that the Bush Administration will allow Medicare to cover prescriptions for sexual enhancement drugs such as Viagra while blocking efforts to give women access to emergency contraceptives that would reduce the need for abortion.


Act TODAY to get the Morning After Pill over-the-counter status

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Submitted by Heather Corinna on Tue, 2005-01-18 17:00

Really, the ONLY reason the MAP -- which is just as safe as, if not safer than, typical oral contraceptive pills -- is not currently over-the-counter is because of the ideology of those opposed to birth control in general -- or those who don't understand contraceptive technology and opt to remain uninformed to better serve their own personal agendas -- not due to health concerns.



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