A controversial ruling : Do judges make rules? or the FDA/expert

What, no hot blooded real debates to stir things up (while I am on vacation)! Absolutely disappointing :(

http://www.bbc.co.uk/news/world-us-canada-22044790#

So here is one ^ to stir up things again. No religion this time :) Ok Darren!

Also, let me see what Judge Larry's viewpoint is on the "Judiciary's" role on such matters :) Should a single judge (or even a panel voting less than unanimous) be re-defining society rules (such as when girls/boys should have access to "drugs", alcohol, some potentially dangerous, without parents/guardian/school nurse/counsellor's/doctor's permission or help) or should they be redifining society rules in the name of justice? Should they be really be involved in areas they have little expertise in and issue controversial rulings on things like what the meaning of "marriage" is ? or stick to the traditional constitutional role given to them as judges?

But first, let us have some real debate (and I mean ....a real hot one! on the pros and cons of such a ruling!)

C'mon guys and girls let me see you flex your brain muscles!

Ok...first in here...no worries! When the word controversial in used I always thing...in 5 maybe 10 years time it will not be so...it will be acceptable, regardless of which topic it's addressing.

The one you speak of here...the morning after pill..while I think it should be monotored and not just used as a method of contraception..I think it should be available to girls who...shall we say get caught up in the moment. To think girls under the age of 17 are not sexually active, or at lease interested is neanderthal and for a 13 year old to have a child when they are themselves still children is ludicrous so...yes let them have the morning after pill...it also saves on the government having to support both parent and child for ever.

Like I said..it should be monotored and...if someone is really abusing the system....by this I mean coming every month or so to get this drug them it has to be investigated more....if they are sexually active continually then they need to be directed to another form....long term form of contraception I mean.

Surely the morning after pill is far more acceptable than an abortion further down the track?

Edit...Just replying to the link you provided at the start of this thread...

Do not disagree with the age of "use" (any is fine as long as it is approved by FDA for that age).
The qn here is, "purchase and use" without supervision of an adult, as implied in the judge's ruling, against FDA's expert panel.

Imagine what can happen:
Day #14 - used pill
Day #15 - used it again
Day # 16 - used it again.

Guess what side effects can result, in some individuals.
So, is the judge a competent authority to prescribe it? without a doctor supervision? or a parent or other understanding consequences of consequetive days of overuse.
Nope, no neanderthals in here :)

First of all, your assertion is absolutely wrong about the FDA banning it. If you read your link you would see the following:

"In 2011, the FDA said it had concluded that the "morning after" pill could be safely used by girls of child-bearing age.
"But in an unprecedented move, Health and Human Services Secretary Kathleen Sebelius overruled the agency.
"She said there was not enough evidence from all potential ages to support removing over-the-counter restrictions. President Barack Obama said he supported the decision."

It was the appointed politician and her boss who restricted the pill's availability.

It is the proper use of judicial power to determine whether the rules and regulations are constitutionally applied. The judge simply made the determination that the FDA experts were right & that the politicians applied the restriction capriciously.

Never said or meant that FDA banned it above. What I referred to is the Judge permitting OTC purchase and use by a "child (independent of an adult supervision)", over-ruling sensible restriction by the HHS secretary and her supervisor the President. He has 2 girls in that age group himself.
Morning after is not exactly a peppermint, is it?

Additionally, by liberalizing and incentivizing the use of the morning after, are we not promoting marketing to a fragile age group who can also get away with the thought that protective contraception is not needed anymore, exposing them to STD and frequent s**

Edit: The FDA does restrict most new medications to use by over 18 age group for several years until it has been sufficiently established that they pose no harm to those under 18. However, in this case Plan B (morning after) being simply a high dose progestin (an ingredient of most BC pills) and not a new drug, it was permissive in its original intent, until the HHS secretary saw the loophole and added the Rx only.

Excuse my error, I must have been confused by your statement:
"The qn here is, "purchase and use" without supervision of an adult, as implied in the judge's ruling, against FDA's expert panel."

Very true, Larry.

It takes several years for Rx drugs to gain OTC status, because of concerns on safety and other reasons. So the HHS secy correctly prohibited the sale of Plan B One-Step and its generic forms to girls younger than 17 unless they had a prescription. (very imp wordings.."unless they had a prescription"). However, Judge Korman's ruling now creates a new society dilemma.
I suspect that it opens up some fundamental issues in which we have to ask ourselves that when teens and pre-teens, age 9-17 are not allowed to buy oral contraceptives (without a Rx), condoms, cigarettes, alcohol or guns, how in the world can we allow them to buy a Plan B (emergency contraception) on their own from the store? Do they understand the risks and the risky behavior it will entail, predictably. A Rx or a restriction that it be bought only by a supervising adult (a parent, school nurse/doc, guardians) is 100% safer than allowing it to be bought as "peppermint pills" to be kept handy...just in case, and share around it with friends in school as the new "smart" thing to do.
That is my concern, exactly...not its supervised use in an appropriate setting.
Judge Korman, by over-ruling a safety concern has inadvertently opened up a whole new can of worms.

I'm fine with it, though I think there could be some quick counseling at the time of purchase. Like, how to use it, side effects, phone number for concerns, etc.

I think this ruling could save a lot of trouble. It may not be logical, but I think there are plenty of sexually active 15 year olds who would rather do nothing (even if it risks getting pregnant) than go to their parents in this situation. The ability of a teenager (and some older folks, too) to willfully, powerfully IGNORE an impending situation is pretty impressive.

Plus, I think... what if there's something like sexual abuse going on? A big chunk of the time, if that's happening, it's happening in the family. Are you going to ask the guardian who is assaulting you for permission to use birth control?

To the point made in the post above me... I would sure as hell rather have some pills on hand just in case, than end up with a bunch of pregnant 16 year olds, just for the sake of proving a point. I agree it's not ideal that young teens be having lots of sex, but I'd rather be realistic and take pragmatic precautions. BC doesn't really make people have more sex. It just makes them have fewer unplanned pregnancies. Risky behaviour isn't going to be stopped by a lack of birth control - it needs to be countered by parental involvement and informative sex education.

I can see your point, and I agree to a large extent. However, an adult should be involved at all times to track the use of "pills" by all juveniles. After all, do we allow 9-14 year old to take Tylenol or Aspirin on their own? Perhaps, instead of putting it in coin vending machines at school or in the peppermint candy shelves :), it could be dispensed by a pharmacist without a Rx, after he/she has screened (can use a pre-approved written screening questionnaire) the person for other pre-existing conditions that may require a visit to a doctor. This way the risks are minimized. Currently:

If you are 17 or older, you can get Plan B from a pharmacist, without a prescription. Bring proof of your age.
If you are younger than 17, you can get Plan B with a prescription from a doctor

I still retain some concerns...of the ruling's impact on the use of safe s** practices in the future and the societal norms in general with this liberalization. I guess I am still old fashioned in my ideas about what is right and not so right :)

What are the side effects, if any? I guess I could google the answer but...thought you'd probably already have done that so...cutting corners here lol!

I don't think the word sex needs asterisks.

Anyway, Sib makes sense. Also, no one wants to take the morning after pill unless there is already a strong feeling of fear or responsibility present. You're preaching to the wrong crowd if you deny them free access to this contraception. Having a parent's approval is ideal but not always a realistic scenario.

And remember that it is often used as a form of secondary contraception. It's called emergency contraception for a reason.I have taken it a couple of times after the condom broke while I was ovulating. I didn't get any side effects, but it is still a sickening thing to put in your mouth.

And..what would your husband Nicko think of that I might ask?

Yeah secondary contraception is not something I had thought of...trying to do the right thing and it goes wrong....I know what I'd do but I've never had to so....does it really taste yuk in the mouth??

Ha, I've told him and he just said something like 'ah shit, that must have sucked, did you get sick?'. It did suck. It was a long time ago when I was venturing very cautiously into the world of sex. After the second time, I decided to go on the pill even though I wasn't having sex regularly. That didn't suit me and my forgetfulness either. For the past few years, I've had the implant under my arm and it's pretty awesome for me, though it does cause unpleasant side effects for many women.
I don't remember how it tasted, I'm not sure it had one. I gulped it quickly.

So Abbey..you say it was long time ago...how did you get this morning after pill back then? Did you have to visit a doctor for a script or what?

No script, no ID. Went to the pharmacist, answered a few questions, signed a questionnaire, got some info, and left with the pill. I think if I was suspected to be under 16, the pharmacist may have had to report me.

My use of the word with s** with asterisks is my choice out of respect for our very young members. I do not want to be seen as giving them more incentive to use the word freely than they already have amongst their peers. Yes feel free to criticize me on that.

I do disagree with the judge's ruling, though not the use of the Plan B or similar pills for those who need it. He could have asked the HHS secy to find safer and better ways to dispense them easily to the <17 age group in a supervised setting, than simply making it OTC for direct purchase by a minor. Certain non-parent adults (counsellers, school nurses/docs, etc) in school and planned parenthood clinics can easily monitor the underage...such as administering the pill, and a follow up pregnancy test to ensure that the girl did not become pregnant despite its use. If she did, they would also know the correct action to pursue it further.

Hellon re: your qn about side effects:

The side effects are similar to PMS :) u know what that is... when the estrogen declines in the last 7 days of a MC, and is replaced by peaking progesterone levels, just more abrupt. Headache, nausea/vomiting, abdominal pain, dizziness, irritability, tender breasts, painful bleeding. However, give the fact that Plan B, a high dose progestin is given only 1 day (sometimes 2), the tolerability is excellent.
Effectiveness is 89 percent when taken within 72 hours, but it can be taken as late as 5 days. It and a similar agent ulipristal acetate (ella), both available in the US, prevent ovulation, not implantation of the fertilized egg (abortion), and are much safer than the abortion pill (mifepristone or RU-486) which aborts an already implanted egg. As they prevent fertilization, and do not induce abortion of an implanted egg, they are also not that controversial from the viewpoint of the church or conservatives.

...if you think sex is a secret from anyone of any age...well. And making sex even dirtier by making it a taboo, elusive subject...well. We obviously have very different approaches to a healthy attitude toward sex. It's a word of science and love and life, it is not a word that contains bile.

But I admire your sensitivity to any 7-year-olds who might be reading this. Yet my question to you is still this: If you want to protect the young ones from merely the word sex itself, why raise an entire forum topic that is based entirely on SEX? Surely you would have predicted that the dreadful word would rear its ugly head somewhere along the line?

Curiouser and curiouser.

I have two sides on this issue.

I've actually done research on this, this last weekend for a paper. The reason I don't like that it's available to every girl, is the lack of rape reports. There are a ton of girls who will just go buy this pill and keep their assault under wraps. It's a terribly shameful thing. Because if there weren't this option, they would be more likely to report and get help other than the morning after pill, and trying to shove their rape under the rug. That's actually quite a common thing among rape victims. I'm not saying that this would make every victim come forward, but it would make a difference, in my opinion, and statistically. This was my case. I never had a rape kit done, because I could go get the pill, and because I wouldn't get pregnant - it was a victory at the time. Which turns out not to be later, in every case I've seen. By then, the evidence is gone, you can't get a rape kit - and prosecuting the case becomes extremely difficult because nearly everything is circumstantial.

On the other hand - I like this fact because it really is helpful to people who are sexually active at any age. Choosing our reproductive health should have no limits, and it does. I believe women should have total control over their bodies - without law restriction, and slander from the media or the people around us.

Again, however, I'm afraid this may encourage girls to become sexually active at a younger age. And to have reason not to use a condom because the pill will prevent pregnancies - not thinking about that the pill doesn't protect against STIs or STDs. Girls who they have made this available to are not mature enough to have sex, and this might make them feel like it's okay.

There's my two-sidedness.

^Exactly why it is a debate. A topic with 2 different views.

Dear Mrs. Abby: I am not sure whether u want to criticize me or my personal views on how freely the word should be used in open forums. I did mention I am old fashioned on its use and did not mind being criticized. But please do not assume that all people who desist from its frequent or open use are ignorant or backwards.

Re: The topic, it is definitely educational and the ruling very controversial and that is why we are having a debate. Most words that I used in this thread are related to science/biology/medicine and not provocative.

Well, I don't think sex is a very provocative word, not criticizing you. Really, no offense intended. Sexual reproduction is a term used in biology, and sex is used in medicine. That's really what this topic is about, if you want to narrow it down.

It depends on the context of how how sex and sexuality are used. No this part of my comment was directed also to Mrs. Abby as well, Ms Linda. I appreciate your thoughts on the topic though.

Sometimes people criticize people thinking that the other person is ignorant, but again, it is a matter of perspective of how little or how much you know about that person in real life (\wink) :) (And this one is also not directed at all to you Ms. Linda)

Addendum: What's in a name...a lot, and how you use it. e.g check this one out (for laughs).. :)

http://en.wikipedia.org/wiki/Fucking,_Austria

I would have written my post to anyone who censors the word sex while raising the topic in the first place. It was a curious thing to me that still has not been explained. Unless being old-fashioned was the explanation. That's fine. Don't take things personally, Mr Lonely.

I have never heard that EC allows more women to hide rape incidents. If these same women wanted to hide the rape in the first place, would they have ever seeked help? Or waited for an abortion? In an ideal world, they would seek help and have free access to EC. That can't always be the case.

Sex education is the most vital thing here. I don't think that EC should be sold in supermarkets, but otherwise it's a much better option than many of the alternatives.

While waiting for the wheel of furture host, Mr. Dib to answer, I might as well take a crack at it.

-So, ^ I get it that the word is extremely fascinating to you, so why not consider become a sex educator, in your spare time. For those of us who shy away from publicly using the word.
-But first you have to check your credentials with the "The Kinsey Institute for Higher Sexication"...it is in need of interns...they can offer research jobs to people who own smartphones. Check them out. :)

Don't you mean s** educator?

You are quite the lolmaker, Mr Lonely, in a passive aggressive kinda way.
Why do you think sex fascinates me so? Because I am able to say the word without blushing? My 8 year old nephew could be a sex educator too then.

I used to study genetics and evolution and developmental biology. I used the word sex about 50 times a day. It does fascinate me because it is wonderful. I have written an ode to it.

Look, I get it, you just have conservative views about a word that makes you uncomfortable. It just doesn't support the topic you have raised, that is all.

Now, now are we not making a judgement on someone we don't know at all!
Passive aggressive??

The last attack on a psychology thread was kind of that, was it not? I think!

And I thought they had a new gene mutation similar to the SLTRK1 gene.

Asides from this, people might be amazed to know that Lysol was once advertised heavily for EC as well...never worked, too many got pregnant!

http://www.omg-facts.com/Sex/Lysol-Was-Once-Advertised-As-A-Feminine/48746?lp=3

"I have never heard that EC allows more women to hide rape incidents. If these same women wanted to hide the rape in the first place, would they have ever seeked help? Or waited for an abortion? In an ideal world, they would seek help and have free access to EC. That can't always be the case."

Well, now you have heard of an EC that allows more women and girls to hide assaults. It's not the product, it's the availability. Any girl who is being raped, or assaulted, now even younger girls, can just go pick up a pill without having reported their assault. If the pill is harder to get - it's easier for them to get help in a sense. In my case, like I said, I didn't get a rape kit done because the pill was available when I was 17. Now it's available for girls younger, and it's going to silence a lot of victims, I think. This is a common trend with rape victims. It's not just something that pops up now and again.

Anyway, moving on. The EC is not a better alternative than abstinence. Kids will be taught over and over, and preached at incessantly, but this seems to give them a free pass to go have sex whenever - without protection. Like I said, they've made it available to people who aren't mature enough to be having sex in the first place.

But, in the end - I don't protest the fact that we can choose the status of our reproductive health. I just dislike the things that come along with opening this up. I agree it is fair. But there's always a negative side to everything.

Preaching abstinence in kids...a very good point Linda. That is what our ancestors did for a very long time, worked to prevent unwanted early life s**, assaults and immature behavior for many Eastern and middle Eastern societies and cultures..still does as proved by the average age of first s** in these societies being over 21*, as against the Western cultures. However, I am not sure if it reduces adult rape, though it does reduce the child rape statistics in the Eastern societies, significantly. In the West, it does not work well , for several reasons, the biggest being permissiveness and openly promiscuos behavior, TV and internet, perhaps

A few years ago (2005), someone in South Africa came up with an interesting answer... Rapex (Rape-aXe)...a rape prevention device! a sort of a removable condom with inside teeth which instantly stops a rape, without permanently harming a person's organ. He has to go to a hospital to get it removed surgically, which in turn may lead to his arrest and prosecution. Somehow, it is yet to be marketed commercially, though I bet there will be a big market for it, if susceptible young worldwide women came to know more about it, particularly when travelling alone in remote areas or countries where safety is a concern.

*Addendum: I found the statistics presented in this table and map interesting and as predicted;
http://chartsbin.com/view/xxj

"That is what our ancestors did for a very long time, worked to prevent unwanted early life s**"

I kind of think our ancestors didn't care too much about people having sex young. I mean, as recent as the late 1600's for sure (think Romeo and Juliet) and in some places even now: if you are a girl and you menstruate (which most people do by age 15 or so), you're sexually viable. People didn't worry so much about premarital sex, because they were marrying/breeding so young, and it was very socially acceptable for them to be sexually active at 14.

I'm not saying it's right, I would definitely have problems with that, but I don't know if we want to lean too heavily on "how our ancestors did things."

On another note, I'm all for teenage abstinence. I really don't think I even held hands with a guy until I was 16 or 17, though I'm probably an exception. ;)

Unfortunately, it's been demonstrated over and over that abstinence-only education doesn't work. I think education needs to be comprehensive: biological, chemical, emotional, even spiritual, when applicable. I think it's unrealistic to just say "don't have sex." I also think you're missing something if you're just teaching "here's how to put on a condom, here's what spermicide is, here's where to get the pill." But I guess I'm not running things. : )

Maybe, but then how else would you explain these statistics. The more Westernized the country, the earlier the loss of virginity. By "our ancestors" I probably meant only a few generations.

http://chartsbin.com/view/xxj

Exception: In Islam and similar cultures (Hinduism included) following Shariah, and similar laws once the girl started menstruating, they were at risk in the ancient days. But, with modernization of cultures these ancient traditional/religious practices have declined significantly as shown by the survey above.

Linda, can you send me links to your research? Very interested in your findings of unreported rape due to EC in young women. That is quite serious. As I said, I know most rape goes unreported, but still unsure how EC exacerbates it. In my mind, a woman either wants to report rape or she doesn't. If a woman gets raped and doesn't want to report it and doesn't have access to EC, what would make her reach for a rape kit instead? In fact, isn't a rape kit a bit of a deterrent to a woman who is already uncomfortable with reporting rape - the kit is said to be invasive, expensive and time-consuming, isn't it? I would have thought these same women would do nothing and hope for the best, otherwise resort to abortion. But these are just my presumed thoughts, never researched, would love to see the details of the study.

Oh, and when I said EC is better than other alternatives, I meant realistically, not ideally. Abstinence is all well and good, but even the best sex education (our best tool to stop the need for EC for young people) isn't foolproof.

If we are only speaking ideally, I think it is far worse and far sadder for a young woman to need access to a thing called Rapex than EC.

Actually, the state pays for the rape kit - so it has nothing to do with money for us.

"In my mind, a woman either wants to report rape or she doesn't. If a woman gets raped and doesn't want to report it and doesn't have access to EC, what would make her reach for a rape kit instead?"

^That's where you're wrong. It's not as simple as she wants to report or she doesn't. The statute of limitations on rape are so long, because it can take years for the victim to report her rape because she bounces back and forth between not wanting to do it, wanting to forget it, or wanting to do it - and getting justice. I'd be happy to send you my paper & notes on it. Not only did I do research, I went to the Harbor House in my town that houses women who have been victimized, and had permissions to talk with them.

"In fact, isn't a rape kit a bit of a deterrent to a woman who is already uncomfortable with reporting rape - the kit is said to be invasive, expensive and time-consuming, isn't it? I would have thought these same women would do nothing and hope for the best, otherwise resort to abortion."

^Yes, the rape kit is deterrent to a woman who is already uncomfortable with reporting rape. And yes, it's invasive, and time consuming. However, not only do hospitals provide the emergency contraceptive when a rape victim steps forward and the kit is performed, they provide AIDS tests, STD tests, and the medication needed for contracting a sexually transmitted infection or disease. If you can just go to the store, and pick up a pill, and act like this didn't happen - it's "ideal" for the woman when this first happens, but she could have infections she doesn't know about. Most women don't just get raped and hope they don't get pregnant. (Sorry if I sound snippy, totally not my intention. Just trying to explain. :p) There is normally some kind of desire to make sure you can control something of your body (coming from the women that I've spoken with). Do some women not do anything at all? Absolutely. I almost did nothing, and good friend of mine actually did nothing. But statistically, girls are compelled to do something to take back a bit of control. And I see that now this is made open to younger women, there could be even more of a decrease in rape reports.

But again - I am not opposed to it. With the victims I've spoken to, they agree that this is convenient, and I do too, but it has the negatives about it.

When you are considered an adult, you should be able to do as you see fit. My daughter is 14, I want to now what is going on with her and I want to be involved in her decision making process. Thankfully for me we have a close relationship and she is quite honest with me about everything and I as a logical person know she is going to make mistakes and that she deserves to have options. While the morning after pill and in some cases even abortion should be an option, the top of the list should be education and birth control.

A panel is not much different that what the FDA is and the FDA has its own problems. So were a new panel of independent judges looked at I would want to know their level of experience and whether or not they have been bought by big corporations, as the FDA has been in many cases. There are so many drugs and products out there that are really not regulated by anyone but the companies which produce them, even though they are supposedly monitored by the FDA.

In the case of the Plan B it was first approved for use in 1999. the oversight FDA panel voted 23-4, an overwhelming majority to make the drug available OTC to 16 and over in 2003, however delayed their official recommendation until 2005. As the FDA officials and staff were still hedging in 2009 whether 17 year olds could use Plan B safely without a prescription -- District Judge Korman ordered FDA to make Plan B available OTC for consumers 17 years and older. Later, in another 2011 petition the Judge took upon himself to make it OTC for people younger than 16, which is what caused a surprise to everyone.

The FDA has 50 subcommittees and independent members (mostly scientists) who are not influenced that easily by "big pharma", and regularly reject many new drug applications for further safety studies or similar reasons. However, outside of the pharmaceutical industry, the FDA is unable to control the sales and marketing of OTC "junk" such as "men's health" or "memory tonic"...which has a huge $6 billion market in the US. The consumer is advised to be discretionary...many of these can be harmful to some individuals.