FDA rejects over the counter morning-after pill
 

I know there was a thread on this before, but i couldn't find it. Feel free to merge the two.

FDA rejects over-the-counter morning-after pill
Thursday, May 6, 2004 Posted: 9:55 PM EDT (0155 GMT)


WASHINGTON (AP) -- The government rejected over-the-counter sales of morning-after birth control Thursday, citing concern about young teenagers' use of the pills. But regulators left open the possibility they will reconsider.

Proponents immediately accused the Food and Drug Administration of bowing to conservative political pressure -- noting that the agency had overruled its own scientific advisers, who had overwhelmingly called easier access to emergency contraception a safe way to prevent thousands of abortions.

In a letter to Barr Laboratories late Thursday, the FDA said there wasn't evidence that teens younger than 16 could safely use the pills without a doctor's guidance.

Warned of FDA's teen concern in February, Barr had proposed allowing nonprescription sales for everyone 16 and older, but requiring a prescription for anyone younger.


the rest of the article can be found here.

I wouldn't exactly rule out bowing to political pressure. I just really don't see the possibility of some 14 year old taking some Ortho to get high! When I took them, all they did was make me throw up/constantly nauseous. I don't think birth control pills could ever be recreational.
I'm curious to see what happens now...

yea i'm interested in this too- but i think they should be available over the counter- i've had numerous friends ask me to take them to planned parenthood or something- just in case- it prevents pregnancy and helps put their minds at ease- but if the doctors is closed- which it is on sundays- etc- then they are out of luck- its messed up...

its available over the counter in europe- i'm considering taking home a few packs so that they are available... (and some nurofen plus - codeine over the counter baby woohooo lol)

p.s hide them in your hand luggage or something :p
 

Oh yep, that's definitely a perk we have here. :D

I asked if they had any when I needed to visit the med center, at spacecamp in AL. They didn't have Nurofen Plus so she asked what was in it and I said ibuprofen & codeine and she said they had nothing in the US with codeine in it (except prescription stuff obviously).

That was about nurofen not the morning-after pill by the way. I don't use the morning-after pill so much. ;)

Aleth, was the morning-after pill what you were thinking of taking a bunch of back home?

What would happen when you went to customs and they found a whole load of birth control pills?

Here in Canada you can also get over the counter medicine with codeine.

swissmiss - I don't think they are worried about them using it to get high, I think they are worried about them not taking it correctly and it not really being effective. At least that's what I got out of the article...:confused:

B/C you're right, if they take too many they'll puke it up before it has any effect! And if birth control pills can get you high, boy have I been missing out on something for a long time!!! :)

Yep, trips to Canada usually involve a stop at the drugstore on the way home......

Wow, I'm sure glad that they want to keep kids younger than 16 from possibly misusing the pills but not from HAVING BABIES. Hi, if you're too young or stupid to follow medication directions, is it really a good idea for you to be popping out kids? WTF?

From what I've heard on the local news lately, kids under 16 can't use cough syrup correctly either -- some of them like to drink it for fun. Maybe we should require a prescription for that too!

Be careful. You'll give the fundies ideas.....

Ok, so if they card for cigarettes and alcohol, why can't they card for this, too? Seems like a reasonable solution to me.

Yeah, but then they'll be sening in older sisters older friends to get them. Just like alcohol and cigarettes.

This may be difficult to believe, but our priest once said he favored the morning after pill in cases of rape. I don't know how many hours it takes for the sperm to reach the egg, but he felt it could be taken BEFORE conception. I sure would like to see this made available if that is true.

The sperm can stay alive for up to 72 hours. If a woman is ovulating precisely at the moment of intercourse, then fertilization can occur quickly, but it may take up to 72 hours for it to occur. This pill can prevent fertilization and it also prevents implantation in the uterus (like the IUD does). It is like a chemical IUD.

However, I thought the Catholic was officially against all forms of birth control no matter what, so this would still go against their beliefs. The priest and nun who ran my RCIA were pretty liberal though and responded to questions about these things with "You need to pray and work out with God what is best for you, ultimately it's between you and Him"

An expert (who I happen to work with) in teen pregnancy research was quoted on our local news radio yesterday stating that there should be little concern about those under the age of 16 using it because they tend to not use any form of birth control anyway. If they aren't using the free condoms being given away, they aren't likely to go out and purchase this either.

I agree with DWAlphaGam though.. they have age restrictions for alcohol and cigarettes, why not just card kids who try to buy it?

Dee

Yes, all forms of BC are outlawed by the faith except rhythm...yeah like THAT'S going to do the job!:rolleyes:

There are more and more priests AND nuns who are "off the record" supporters of protection, though they don't usually preach it from the pulpit, rather the confessional or in private conversations. This is one of those "sticky" points where American Catholics have been known to take "issue" with the Vatican. Still, there are those who follow word for word the established guidelines. For me-BC and the morning after pill are real choices for people. We're done populating the world you know...

http://www.washingtonpost.com/wp-dyn...2004May12.html

2 FDA Officials Urged to Resign Over Plan B
Lawmakers Call Decision Political
By Marc Kaufman
Washington Post Staff Writer
Thursday, May 13, 2004; Page A03

A dozen members of Congress yesterday called for the resignation of the two Food and Drug Administration officials most responsible for last week's decision to keep emergency contraception a prescription-only drug.

At a news conference, Rep. Louise M. Slaughter (D-N.Y.) said Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, and Lester M. Crawford, acting FDA commissioner, allowed politics to trump science in their decision.

"The FDA's decision to ignore its own scientific advisory board and its own staff clearly demonstrates the leadership would rather pander to conservative interests than protect women's health and well-being," said Slaughter, co-chair of the Congressional Pro-Choice Caucus. She also called on the General Accounting Office, Congress's investigative arm, to probe charges that the FDA's decision on the emergency contraceptive, Plan B, was driven by politics.

A coalition of women's health and pro-choice religious groups, many of them participants in the large women's rally on the Mall last month, joined the members of Congress in calling for a review and reversal of the Plan B decision.

On Friday, 41 members of Congress, most of them Democrats, wrote their own letter to Crawford asking that the decision be reviewed and overturned.

Last Thursday, the FDA sent the distributor of Plan B, Barr Laboratories, a "non-approvable" letter rejecting its application to make Plan B available over the counter. The FDA said the company had not provided enough information to ensure that the drug could be safely used by girls 16 and under.

The rejection came despite a 23 to 4 vote in favor of approval by an FDA expert advisory panel in December. Galson also acknowledged last week that the FDA staff that reviewed the application had recommended that it be approved.

Galson said last week that politics played no part in his decision, and yesterday the FDA's associate commissioner for external affairs, Peter Pitts, said Crawford and Galson "remain comfortable with their decision." He said the agency gave Barr Labs a clear pathway to win approval in the future.

The Plan B application was opposed by some social conservative groups, and 49 conservative members of Congress wrote a letter to President Bush in January asking that the application be rejected.

Also yesterday, Rep. Carolyn B. Maloney (D-N.Y.) announced that she would introduce legislation today requiring the FDA to review the Plan B decision and affirm that it is not based on politics.

"When a scientific panel votes 23-4 in favor of over-the-counter status but the FDA goes the other way, there has to be something at work other than science," Maloney said. "No one should object to this bill. If politics indeed didn't influence the decision, they should affirm that without fear."


© 2004 The Washington Post Company


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Note: FDA is not required to follow the advice of its advisory board. However, it is subject to public scruitiny when it doesn't.