Decision on "Plan B" Morning-after pill again delayed by the FDA

[shira]

NY Times Article

Just one more example of disgusting, intellectually dishonest behavior by public institutions that are supposed to base their decisions on scientific consensus and the public good, not right-wing religion and politics.

Lester M. Crawford, the commissioner of food and drugs, said in a news conference that his agency had decided that the science supported giving over-the-counter access of the drug to women 17 and older, but that the agency could not figure out how to do that from regulatory and practical standpoints without younger teenagers' obtaining the pills, too.

The application "presented us with many difficult and novel policy and regulatory issues," Dr. Crawford said.

The agency will open a 60-day comment period for advice, but the commissioner would not predict when the agency might make a final decision.
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The delay infuriated Senators Hillary Rodham Clinton of New York and Patty Murray of Washington, both Democrats, who had allowed the Senate to vote last month on Dr. Crawford's nomination as commissioner only after the health and human services secretary, Michael O. Leavitt, promised that the agency would decide on Plan B by Sept 1.

"They broke their promise to Senator Murray and me, to the Congress and to the American people," said Mrs. Clinton, who described the decision as "outrageous," "disturbing" and "a wake-up call to everybody in this country."
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An agency advisory committee voted, 23 to 4, in December 2003 to approve the Barr [= Barr Laboratories, who manufacture the drug] application to sell the drug over the counter. Staff members at the agency also said the application should be approved. But the director of the agency's drug center, Dr. Steven Galson, announced in May 2004 that he had decided to override the advisory committee and the staff members and reject the application.
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Barr noted that the agency had already approved over-the-counter sales of nicotine gum only to people older than 18 and that cigarettes and alcohol were routinely sold with age restrictions.

 

[Jhhnn]

Funny, that... Retailers seem to do a pretty good job when it comes to cigarettes, alcohol and porn...

 

[1EZduzit]

Originally posted by: shira

Just one more example of disgusting, intellectually dishonest behavior by public institutions that are supposed to base their decisions on scientific consensus and the public good, not right-wing religion and politics.

Sad, but true.

 

[jackschmittusa]

I guess it is only sad if you recognize that what they have used is a "we are too stupid to figure it out" excuse. Quality government at work.

 

[zendari]

Cue lawsuit when 12 year old buys pill and something happens to her.

At least perhaps now Communist states won't force pharmacies to carry this pill anymore. I hope.

 

[umbrella39]

Cue lawsuit when 12 year old buys alcohol and something happens to her. Oh wait, minors can't purchase alcohol. Oh wait, 12 year olds would not be able to buy the pill either.

MOOT.

 

[zendari]

Originally posted by: umbrella39
Cue lawsuit when 12 year old buys alcohol and something happens to her. Oh wait, minors can't purchase alcohol. Oh wait, 12 year olds would not be able to buy the pill either.

MOOT.

Yes, because we both know underage drinking is such a rarity in this country.

/sarcasm

 

[1EZduzit]

Originally posted by: zendari

Originally posted by: umbrella39
Cue lawsuit when 12 year old buys alcohol and something happens to her. Oh wait, minors can't purchase alcohol. Oh wait, 12 year olds would not be able to buy the pill either.

MOOT.

Yes, because we both know underage drinking is such a rarity in this country.

/sarcasm

Yeah, as is underage sex.

 

[zendari]

Originally posted by: 1EZduzit

Originally posted by: zendari

Originally posted by: umbrella39
Cue lawsuit when 12 year old buys alcohol and something happens to her. Oh wait, minors can't purchase alcohol. Oh wait, 12 year olds would not be able to buy the pill either.

MOOT.

Yes, because we both know underage drinking is such a rarity in this country.

/sarcasm

Yeah, as is underage sex.

When people die of drinking nothing happens. When people die because they took a pill the family sues for 250 million dollars.

 

[1EZduzit]

Originally posted by: zendari

Originally posted by: 1EZduzit

Originally posted by: zendari

Originally posted by: umbrella39
Cue lawsuit when 12 year old buys alcohol and something happens to her. Oh wait, minors can't purchase alcohol. Oh wait, 12 year olds would not be able to buy the pill either.

MOOT.

Yes, because we both know underage drinking is such a rarity in this country.

/sarcasm

Yeah, as is underage sex.

When people die of drinking nothing happens. When people die because they took a pill the family sues for 250 million dollars.

So, how many are dying in the countries where this pill has been legal for years??

 

[1EZduzit]

Hillary Flowers, a 23-year-old member of NOW from New York City, said she had to call 20 doctors and then pay $200 for an office visit to get a prescription for Plan B after a condom broke during sex with her boyfriend. When she faced a second contraceptive failure awhile later, she said, she couldn't afford the time or the expense, so she took a handful of left-over birth control pills in the hope they would work, but not make her horribly ill.

Sell next-day pill over the counter, FDA panels say

 

[zendari]

Originally posted by: 1EZduzit

So, how many are dying in the countries where this pill has been legal for years??

Text

"The risks of emergency contraception to adolescents have never been adequately studied. To gauge the level of risk that the drug poses to teens, one need only to consider the damage caused by Norplant. This progestin-only hormonal contraceptive?he same active ingredient as Plan B (morning-after pills)?is no longer available for use in America because it is so dangerous. Known risks include significant weight gain, ovarian cyst enlargement, gallbladder disease, high blood pressure and respiratory disorders.

"Among teenagers, some of these common side effects could result in increased rates of bulimia, anorexia, or clinical depression. Also, an increased risk of ectopic pregnancy has been associated with use of Plan B-type emergency contraception."

Add to that the false security this pill would provide exposing young girls (and women) to sexually-transmitted diseases and exploitation by unscrupulous men.

In more ways than one, the "morning after pill" is not good for children. In fact, it's not good for anybody.


Since Barr has already reccomended that a prescription still be required for individuals under 16 its necessary for them to also provide a way of implementing such a rule.

 

[umbrella39]

Originally posted by: zendari

Originally posted by: 1EZduzit

Originally posted by: zendari

Originally posted by: umbrella39
Cue lawsuit when 12 year old buys alcohol and something happens to her. Oh wait, minors can't purchase alcohol. Oh wait, 12 year olds would not be able to buy the pill either.

MOOT.

Yes, because we both know underage drinking is such a rarity in this country.

/sarcasm

Yeah, as is underage sex.

When people die of drinking nothing happens. When people die because they took a pill the family sues for 250 million dollars.

Bullsh!t. When kids die because a store sold them liquor at age 12 (going along with your failed arguments logic), the store gets sued. Again, your point was MOOT.

 

[13Gigatons]

The easy answer is that you won't prevent teenagers from getting Plan B anymore then you stop them from getting drugs or guns. It's the law of supply and demand.

 

[zendari]

Originally posted by: umbrella39
Bullsh!t. When kids die because a store sold them liquor at age 12 (going along with your failed arguments logic), the store gets sued. Again, your point was MOOT.

The problem isn't just that stores might sell this product to minors, its also that minors can ask someone older to buy it for them. Just like they do for cigs and alcohol.

 

[jahawkin]

You would think that anti-abortion groups would be supportive of something that would reduce the number of abortions in this country.

 

[kogase]

Originally posted by: zendari

Originally posted by: umbrella39
Bullsh!t. When kids die because a store sold them liquor at age 12 (going along with your failed arguments logic), the store gets sued. Again, your point was MOOT.

The problem isn't just that stores might sell this product to minors, its also that minors can ask someone older to buy it for them. Just like they do for cigs and alcohol.

So what's the problem again? I guess the problem is that cigarettes, alcohol, baseball bats, and sharp pencils are all still being sold at stores... we must ban them! We must purify our souls!

 

[kogase]

Originally posted by: jahawkin
You would think that anti-abortion groups would be supportive of something that would reduce the number of abortions in this country.

The soul is injected by God when the sperm meets the egg. This pill is the work of Lucifer, Prince of Darkness. Not only that, but if people didn't have to worry about getting pregnant, they may start having dominion over their own bodies (having casual sex, that is), which is a big no-no.

 

[Rainsford]

Originally posted by: zendari

Originally posted by: umbrella39
Cue lawsuit when 12 year old buys alcohol and something happens to her. Oh wait, minors can't purchase alcohol. Oh wait, 12 year olds would not be able to buy the pill either.

MOOT.

Yes, because we both know underage drinking is such a rarity in this country.

/sarcasm

So do we outlaw alcohol?

 

[Rainsford]

Originally posted by: zendari

Originally posted by: 1EZduzit

Originally posted by: zendari

Originally posted by: umbrella39
Cue lawsuit when 12 year old buys alcohol and something happens to her. Oh wait, minors can't purchase alcohol. Oh wait, 12 year olds would not be able to buy the pill either.

MOOT.

Yes, because we both know underage drinking is such a rarity in this country.

/sarcasm

Yeah, as is underage sex.

When people die of drinking nothing happens. When people die because they took a pill the family sues for 250 million dollars.

Ah yes, the conservative ethics. Who cares when someone dies as long as they don't sue some giant pharm company worth 11 gajillion dollars?

 

[Jhhnn]

From zendari's link-

"The risks of emergency contraception to adolescents have never been adequately studied."

Yep, and they intend to make sure it stays that way...

And this lovely bit of fearmongering-

"Among teenagers, some of these common side effects could result in increased rates of bulimia, anorexia, or clinical depression."

Uhh-huh, and it could result in flying to the moon on a pogostick, too...

 

[Vic]

I can't even get cold medicine over the counter anymore...

 

[Tab]

Originally posted by: Vic
I can't even get cold medicine over the counter anymore...

Can't it be used as a date-rape drug or used as an ingredient in ex?

 

[Vic]

Originally posted by: Tab

Originally posted by: Vic
I can't even get cold medicine over the counter anymore...

Can't it be used as a date-rape drug or used as an ingredient in ex?

Pseudophedrine can be used to make meth. But it's just more reefer madness to stir up the public though. A couple other chemicals required to make meth are controlled substances, and the meth makers seem to have no problems getting those. This will do nothing except force people waste time and money to go to their doctors to get a script to buy NyQuil...

 

[sandorski]

Originally posted by: Jhhnn
From zendari's link-

"The risks of emergency contraception to adolescents have never been adequately studied."

Yep, and they intend to make sure it stays that way...

And this lovely bit of fearmongering-

"Among teenagers, some of these common side effects could result in increased rates of bulimia, anorexia, or clinical depression."

Uhh-huh, and it could result in flying to the moon on a pogostick, too...

Not to mention that those side-effects were the result of the implants that release their ingredient 24/7 for months when this pill is used a few times at most.