Women's Groups Pressure FDA on 'Morning-After' Pill

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WASHINGTON (Reuters) - Women's rights groups seeking easier access to emergency contraception are pressuring U.S. regulators as they try to decide whether to approve a non-prescription "morning-after" pill.

The Food and Drug Administration last year denied a request by Barr Pharmaceuticals Inc.'s to sell the contraceptive, called Plan B, over the counter. That sparked a furor over whether the decision was based on scientific evidence or political considerations.

FDA officials cited a lack of information on whether girls under 16 could use the drug safely without a doctor's input. That prompted Barr to refile its request that the pill be made be available without prescription to patients 16 and older.

Plan B reduces the chance of pregnancy if it is taken within 72 hours of unprotected sex. It contains higher doses of the hormone progestin than that in regular birth-control pills and women are supposed to take two tablets 12 hours apart.

With an FDA decision expected next week, some women's groups have been petitioning the agency for approval. A handful of protesters were arrested on Jan. 7 at the FDA's Maryland headquarters when they tried to block the entrance.

Supporters argue that easier access to Plan B would reduce the number of abortions by helping more women get the pills in time. Opponents counter that easier availability would promote promiscuity and sexually transmitted diseases, particularly among teen-agers.

Barr, based in Woodcliff, New Jersey, offered a compromise in July and asked to sell the drug over-the-counter to women of 16 and older who show proof-of-age. Younger patients would still need a doctor's prescription.

Link to "Morning After" Pill Article

Should the "morning after" pill be available on a non-prescription basis? Should minors be able to purchase the medication? Are there any problems that you forsee if this drug is approved for non-prescription use?

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Re: Women's Groups Pressure FDA on 'Morning-After' Pill
Should the "morning after" pill be available on a non-prescription basis?

YES

Should minors be able to purchase the medication?

YES

Are there any problems that you forsee if this drug is approved for non-prescription use?

YES, but no moreso than with any other medication that changes from prescription to non-prescription.

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Quote:

Plan B reduces the chance of pregnancy if it is taken within 72 hours of unprotected sex.

The thing that bugs me about having to get a prescription, is that the drug is useless after 72 hours. Let's say that a woman has unprotected sex (or protected, and the protection fails), on a Friday night, and Monday is a holiday, by the time she can get to a doctor, it is too late.

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Phoenix32890 wrote:

Quote:
Plan B reduces the chance of pregnancy if it is taken within 72 hours of unprotected sex.

The thing that bugs me about having to get a prescription, is that the drug is useless after 72 hours. Let's say that a woman has unprotected sex (or protected, and the protection fails), on a Friday night, and Monday is a holiday, by the time she can get to a doctor, it is too late.

I'm not so sure that has to be a problem. In my area, at least, I know of clinics (or, even emergency room docs) where a prescription could easily be obtained on that Friday night/Saturday morning.

My responses were based more on the politics of controlling female sexuality.

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Quote:

My responses were based more on the politics of controlling female sexuality.

graffiti- That is really what this is all about. There are people out there who would put as many roadblocks as they can in the way of women controlling their own bodies.

I was thinking though, on a more practical note. I think that there are many women who would much rather go to her friendly, neighborhood druggist to get the pills, than to have to wait in line and go through the rigamarole of an E.R. Even having to go to an E.R. can be traumatic for many women. I would suspect that many would take a chance rather than putting themselves through the ER process.

Again, having to go to an ER is simply another roadblock.

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Yes, Phoenix, I agree completely. No question in my mind that these pills must be made OTC ASAP.

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I even....................no, especially, think that the under 16s should be allowed OTC access to the medication. Sure, there may be some who abuse it, and use the pill as contraception. But then again, there are people who abuse ANY drug. I think that the vast majority of girls will use the pill when necessary, saving themselves from a life of dropping out of school, being placed in a role for which they are not ready, and condemning themselves to a life of perpetual poverty.

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Precisely! We are in complete agreement on this, Phoenix. :wink:

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For the benefit of Irish and British citizens, could you explain what the legal age in the USA is for a "minor" ? Thanks.

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Quote:

In most states, any person under 18 years of age. All minors must be under the care of a competent adult (parent or guardian) unless they are "emancipated"--in the military, married or living independently with court permission. Property left to a minor must be handled by an adult until the minor becomes an adult under the laws of the state where he or she lives.

Linkto Definition of "Minor"

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So a "minor" is up to and including the age of seventeen (excluding the exceptional causes cited) ?

Is this a federal law, or does it vary from state to state?

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Bib- Not really sure. From my experience, it is usually 18. There are differing laws from state to state in terms of marriage, driver's licenses, etc. I don't know how that would affect things like contracts.

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Thanks Phoenix.
I'm curious whether the issue you have raised would be treated differently from state to state due to possible age of consent issues re definition of "minor" age.

Anyhow, here's a challenge for you - like me, I know you like to to be resourceful and check out references, etc. Let's see what you can find on this one? :wink:

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Women should have complete autonomy over their bodies.
I can see many people using a slippery slope argument on this one and argue that it'll soon become a convenient form of birth control.
But all you have to do is speak with a women who has taken said pill, and she'd agree that it's not something she'd want to have to endure on a regular basis.
It is the equivalent of taking one week's worth of birth control pills at one, if I remember correctly in terms of effects.

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candidone1 wrote:

It is the equivalent of taking one week's worth of birth control pills at one, if I remember correctly in terms of effects.

Really? Is there any medical citations for this?

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It's simply an extension of the administrations fight against, fetal stem cell research and abortion.

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While I don't like the idea of making these OTC in general, I could live with it, but certainly not for minors. Teenagers aren't often accused of using good judgement. Moral/ethical/abortion issues aside, there are health issues to take into consideration. The low doses of hormones in BC pills have been linked with several health risks; at this time we don't really know the long-term effects of MAP, particularly if used more than once. Without speaking to a doctor, teenagers in particular may think that if one is good, two is better and cause themselves serious harm.

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I was under the impression that the FDA's function was to evaluate the safety of medications. Not to pass judgement on them based upon moral or religious grounds. How could I have been so wrong?

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That was my point - the current debate seems to be around the ethical issues and not the safety issues. There are plenty of safety issues to talk about and that IS the FDA's job.

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Bibliophile the BibleGuru wrote:

candidone1 wrote:
It is the equivalent of taking one week's worth of birth control pills at one, if I remember correctly in terms of effects.

Really? Is there any medical citations for this?

No..I can't back that up with anything just yet. This was old information that I had been given through an MD here in Canada a few years back.
The pill has been available for a few years, and I just remember hearing that it was just a turbo-charged birth control pill...and it really f*cked up whoever took it.
Obviously.

I'll try to get back with something more concrete.
But I can't back up what I said with a link...it's just what I vaguely remember.

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Women's Groups Pressure FDA on 'Morning-After' Pill

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