When will the Morning After Pill be approved by the FDA?

Women are being treated like second class citizens here. What gives?

There's a new law in Ohio that will allow men to beat up their girlfriends.
http://www.democraticunderground.com/discuss/duboard.php?az=view_all&address=104x3348161

and are the ones wanting it and abortions....

Remember that it wasn't approved during the Clinton administration either.

Hearing on this subject on C-Span. Hillary Clinton was giving the FDA head all kinds of crap about why this pill has not been approved for the market. The FDA guy said it was ready to go, but they were working on the labelling. There seems to be a problem with calling it a pregnancy prevention pill or a pregnancy termination pill.

Anyway, Barbara Mikulski, Patty Murray, and Hillary ganged up on the FDA chief. He finally agreed to meet with them privately to discuss this further. Of course, the Republican Chairman tried to discourage this and mumbled something about how hard it would be to get them all together. Mikulski shouted at the Chairman, you just set up the meeting and we will be there.

Go lady Senators! They were really ticked off.

nt

There are a few different pills that are often called "morning after" pills. Mifeprex (a.k.a. RU486, mifeprestone) is approved, but only available through certain prescribers and after filling out lengthy Patient Agreement paperwork. Then there's the emergency contraceptive high-dose birth control pills, (a.k.a. Plan B) that is more widely available and in some states can be dispensed in emergency settings by a pharmacist without directly seeing a physician. So these are all FDA-approved, but they're not available over-the-counter. Is that what you were asking about? Or is there something else out there that I haven't heard of?

As an aside, I don't see the FDA approving oral contraceptives or emergency contraceptives at OTC. My own major concern with them going OTC is that they do have some potential adverse effects and special instructions that should be discussed with a health care professional. (But on the other hand, so does cold medicine... so that kind of ruins my argument) There are a lot of advocacy agencies working to make collaborative practice agreements between doctors and pharmacists to allow pharmacists to dispense emergency contraception without a prescription. I think that could to a lot to improve access. But adverse effects and improper use aren't what the FDA was most concerned about. They were more worried that it would encourage risky sex behavior and increase teenage sex.

now arbitrarially deciding that they don't want to fill the birth control prescriptions of "sinners" (in one case actually holding a woman's prescription hostage so no one else could fill it, either, and in another case denying emergency contraception to a rape victim) it becomes abundantly clear to me that the only reasonable workable solution is to make all oral contraceptives available OTC.

Yes, there are health concerns. But there are health concerns with just about everything, including- as you say- cold medicine. Unfortunately the way things are arranged now encourages unwanted pregnancies.. if the right-to-life crowd really was interested in reducing abortions, they would be on the forefront of this, but instead they are actively anti-birth control... which only confirms my deeply held suspicion that the agenda is really about getting people to stop fucking.

As far as any NEW forms of contraception or morning after pills? Nope, not going to happen. Likewise, I hold out very little hope of existing oral contraceptives being made any more available. I suspect we will see a concerted effort made against their availability, terminating in a drive for criminalization... similar to the drive to criminalize abortion.

In fact, the fundamentalist goons Bush has stacked the FDA with have actually said that if the birth control pill was discovered today, they would not approve it-- solely because of the "social impact" it would have.

Welcome to the American Theocracy.

I completely agree, religious fundamentalism has little or no place in science or medicine. A pharmacist myself, I would NEVER push my own religious beliefs on a patient. My duty is to the patient, providing them with safe medication and drug information. Of course, I work in academia, not the retail setting, so I haven't dispensed a prescription in years. Unfortunately, there are too many of us (pharmacists and physicians, too) making health decisions for our patients based on our personal beliefs about sex and misunderstanding of how the drug works in the first place. If the concern was reducing abortions, fundies would want every woman to carry emergency contraception in her purse. If their concern was women's health and reducing STDs, they'd support condom dispensers on every street corner. But that's not their focus, it never will be, and I'll never understand their logic.

Your point about the FDA is well-taken. The recent appointees to FDA advisory boards have been a cause for concern among the medical research community for a while. Too few people realize the impact that this could have on the drug approval process in the US. It's hard enough for the FDA to function when nearly everyone involved has some sort of conflict of interest or relationship with the industry, now religious freaks who don't seem to believe in science are supposed to evaluate the validity of complex research? I'm getting angry all over again thinking about it.

Just one thing I'd have to disagree with you on a bit. I don't think the fundy agenda is really to stop people from fucking. They love big fundy families, don't they? I think the agenda is to stop unmarried people from fucking. Or maybe they want people to stop enjoying it?

-SLD

in my opinion.

The only birth control fundies are OK with is "natural family planning" which involves not having sex when a woman wants it most and her body will respond most. The only conclusion I can draw from that is that we aren't supposed to enjoy sex.

It turns out that abstinence doesn't even seem to be as important to them as promoting their religious agenda:

There are several comprehensive sex ed programs (that teach about abstinence and contraception) that are effective in delaying the onset of sexual activity in teens.

There are ZERO refuse-to-teach-contraception/abstinence-only that delays sexual activity in teens.

So, these zealots oppose the programs that are more effective in increasing abstinence-the-behavior while supporting the ineffective ones.

Apparently, for them, spreading their fanatic religion is far more important than preventing pregnancies, reducing abortions, or even increasing abstinence.

This is about Plan B, emergency contraception. (Mifeprix/RU-486 is completely different, is for medical abortion and is not and should not be called morning-after pill)

The whole "what if it causes an increase in promiscuity?" is a sham question.

This question, as well as the same about accurate sex ed and contraception were interesting many years ago, were raised, were extensivley studied and the answers were proven. For quite some time we have had the answer: These measures do NOT increase sexual risk taking. But they do decrease unintended pregnancies. It has been well proven.

It is a dishonest trick to keep asking this question as if we didn't already know the answer.

As for "adverse effects" these meds (Plan B is progresterone only) are safer than tylenol. There have been no deaths secondary to these meds.

The fact that Plan B is not already over the counter shows an extreme and blatant ignorance of the science. There is an overwhelming medical consensus on the safety and effectiveness. In fact, all of the credible medical groups (ACOG, AMA, AAP, APHA) support OTC status for this to prevent unintended pregnancies. The FDA decisions not to approve/delay are purely political.

As long as these cretins equate taking a pill that prevents fertilized eggs from implanting in the uterine wall with taking a knife to your child's throat, that pill will never be FDA-approved.

The pill stops pregnancy. But these fuckers run around screaming "It kills babies!" Naturally, no one wants to kill babies...well, no one except for George W. Bush, who has no moral compass and has developed a taste for Iraqi baby blood. (And we won't even start on Sun Hudson.)

So as long as the Religious Wrong has the people thinking this pill kills babies, when in reality it keeps fetuses from happening in the first place, the pill will never be approved.