FDA Debates Sale of Morning-After Pill

[MrRant 0]

WASHINGTON - Government advisers debated Tuesday whether it was time to put emergency contraception _ the morning-after pill _ on pharmacy shelves right next to the aspirin, available without a prescription.

 

The nation's largest gynecologists' group urged the move, saying it would greatly increase women's ability to get the pills in time to prevent pregnancy within 72 hours of rape, contraceptive failure or just not using birth control.

 

Used widely, emergency contraception could cut in half the nation's 3 million unintended pregnancies each year, and in turn prevent hundreds of thousands of abortions, proponents told scientific advisers to the Food and Drug Administration.

 

"There is a public health imperative to increase access to emergency contraception," said Dr. Vivian Dickerson, president-elect of the American College of Obstetricians and Gynecologists.

 

Morning-after pills have been sold by prescription in this country since 1998 under the brand names Plan B and Preven. Now Plan B's maker wants to sell its brand without a prescription, as is done in 33 other countries.

 

The FDA will make a final decision on the morning-after pill in "a matter of months," Commissioner Mark McClellan said Tuesday.

 

Asked whether political considerations would be taken into account, McClellan said, "We have a lot of information coming in. It's very much a science-based process."

 

The FDA says emergency contraception is safe, having been used by millions of women here and abroad with few side effects. The question, FDA said, is whether women will understand how and when to take emergency contraception without professional advice.

 

In a study of 585 women offered nonprescription emergency contraception, more than 90 percent correctly took the first dose of Plan B within three days of unprotected sex. A second dose is supposed to be taken 12 hours later, and 73 percent took that dose on schedule. Most others were a few hours off, although several of FDA's advisers said that shouldn't lessen the effectiveness. They added that in fact, the drug may actually work as well if both doses are taken at the same time.

 

Morning-after pills contain higher doses of the hormones than in regular birth control pills. If a woman already is pregnant, they have no effect. They work by preventing ovulation or fertilization, and possibly by interfering with implantation of a fertilized egg into the uterus, the medical definition of pregnancy.

 

Consequently, emergency contraception hasn't been nearly as controversial as RU-486, the abortion pill.

 

It does have critics who oppose any interference with a fertilized egg. The debate drew dozens of proponents and critics into a sometimes angry discussion Tuesday, which occasionally veered into the morality of contraception.

 

Women who want easier access to emergency contraception show an "inability to control themselves in sexual situations," said Jennifer Taylor of the anti-abortion Human Life International. Others, including a Virginia legislator, made accusations that "sexual predators" or "playboys" would use the pills to abuse women.

 

Women deserve control over their reproductive health, insisted women's advocates and a group of college students who talked of having to fight to get emergency contraception after condom breakage.

 

"Please do not insult our intelligence or belittle us," said Linda Freeman, who told of desperately calling New York City clinics before finally finding one that would phone in a prescription for her without a $150 doctor visit that she couldn't afford.

 

Using Plan B within three days of unprotected sex cuts the chance of getting pregnant by up to 89 percent, said manufacturer Barr Laboratories.

 

Some clinics let women try it within five days, but the FDA hasn't formally said it's effective for that long.

 

The sooner it's used, the more effective it is. But in addition to delays required to get a prescription, demand is so low that many pharmacies don't keep emergency contraception in stock, Barr said. One survey found only a third of Pennsylvania pharmacies could fill a prescription within 24 hours.

 

To improve access, five states already allow women to buy the morning-after pill directly from certain pharmacists without a prescription, so-called "behind the counter" sales. Those states are: Washington, California, Alaska, Hawaii and New Mexico.

 

If FDA lifts the prescription requirement, the question would become whether morning-after pills would be sold over-the-counter like other products, or if pharmacists would have to hand them over upon request like in those five states _ an option that would make advice available if desired.

 

Interesting.

[kkktookmybabyaway 0]

Eh, don't really care.

 

Then again I am an oppressor...

[Guest Salacious Crumb]

This has bad idea written all over it.

 

This is not like taking cold medicine or something of the like. This could have serious side effects for the person and I think it's a bad idea to just buy it without a doctor making sure it's not going to do permanent damage.

[SpikeFayeJettEdBebop 0]

Well....I don't really care, as Im not going to be having sex on a normal basis for a few years so, im sure they will be a better alternative for my friend-of-the-moment. Otherwise, I don't care, as I can't get pregnant, and Im not really planning on getting any sperm up in me.

[Edwin MacPhisto 0]

Make it non-prescription. Unlike RU-486, this hasn't caused *any* health crises as far as I know, and the utility is absolutely worthwhile. If a few stupid individuals abuse it by using it in lieu of regular birth control, so what? They'll spend money on it, they won't have to deal with the health risks of abortion, and everyone's a winner. And in the cases of rape victims, it's an even bigger no-brainer.

[Dr. Tom 0]

I'm all for making it non-prescription. If they want a pharmacist to dispense it, that's fine, since s/he could answer questions, give advice, etc.

[2GOLD 0]

This is safer as a prescription med.

 

Imagine if some 12 year old boy tries to give this to his young girlfriend and it does something dangerous to them? Too many risks involved just as a over the counter right now.

 

I think, for safety only, that this is the type of thing that needs to remain doctor prescribed.

[Dr. Tom 0]

Imagine if some 12 year old boy tries to give this to his young girlfriend and it does something dangerous to them?

No responsible person would sell something like this to a 12-year-old. Presumably, if pharmacists are the ones who dispense this, they wouldn't be giving it out to people who have just hit puberty and want to celbrate by giving their new pubes a workout. Perhaps in the cases of people under a certain age (I imagine it would be the age of consent, which varies by state), it should have to be prescribed by a doctor?

[2GOLD 0]

Perhaps in the cases of people under a certain age (I imagine it would be the age of consent, which varies by state), it should have to be prescribed by a doctor?

I can agree with that.

 

I can really see both sides of this situation though so it is interesting. What I really wonder about is how many lawsuits will get thrown around if the pill doesn't work all the time and people start getting preg?

[RepoMan 0]

This is safer as a prescription med.

 

Imagine if some 12 year old boy tries to give this to his young girlfriend and it does something dangerous to them? Too many risks involved just as a over the counter right now.

 

I think, for safety only, that this is the type of thing that needs to remain doctor prescribed.

What is some adult gets drunk, forgets to take her pill and to make the dude wear a condom, and dosn't want to get pregent. Really what's more likely to happen? It obviously should be over the counter. A bet a 12 just trying to buy some over the counter allegry drug would be questioned, let alone the mourning after pill.

[Guest Agent of Oblivion]

I'm ALL for this. Sometimes, I half-jokingly hope they'll start mixing birth control pills in school lunches.

 

If the pill is safe, I absolutely think it should be OTC, and considering that it's been used for a while now, there's really no reason for it not to be.

 

/Oh no, it's going to promote immoral behavior.

 

Would you rather have a pregnant daughter or a not pregnant daughter?