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

[zendari]

Originally posted by: 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?

No, we come up with a system to better prevent minors from obtaining alcohol. Or in this case a system to prevent minors from obtaining a pill without a prescription, at least until the risks of emergeny contraception to adolescents have been adequately studied.

Have any ideas?

 

[zendari]

Originally posted by: Rainsford

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?

Probably the American consumer paying increased health insurance into the pockets of these illegal frivolous lawsuits.

 

[Thump553]

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.

This part really burns me up. The Senate held up the confirmation of the acting head of the FDA specifically because of the two year delay in approving this drug. That hold was released upon his specific and explicit promise that the FDA would act-a promise he clearly broke.

Dishonesty in government in furtherance of supposed higher ethical standards-what a flipping joke.

 

[shira]

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.

Heaven forbid some underage girl should want a pill to avoid getting pregnant. Somehow, minors getting cigs and alcohol hasn't spelled the end of civilization. How can the risks associated with Plan B pills be even a 100th of the risks of underage drinking? Yet alcohol is legal and Plan B is indefinitely on hold? Total crapola!

All this talk of the danger to minor girls is just BS. It's the anti-abortion radicals making lame excuses. "We don't know how to sell OTC products with age restrictions." Doze po widdle gurlz! We must pwotect dem from da horrow of Plan B overdose.

Give me a BREAK! What nonsense.

The panel that voted 23-4 in favor of approval knows the risks. Birth control pills are safe and effective, and all Plan B is is a triple-strength dose of birth control. Ohhhhhh. The DANGER. OOHHHHHH, the horror. Puleeeeeeeeeeeze!

 

[zendari]

Originally posted by: shira

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.

Heaven forbid some underage girl should want a pill to avoid getting pregnant. Somehow, minors getting cigs and alcohol hasn't spelled the end of civilization. How can the risks associated with Plan B pills be even a 100th of the risks of underage drinking? Yet alcohol is legal and Plan B is indefinitely on hold? Total crapola!

All this talk of the danger to minor girls is just BS. It's the anti-abortion radicals making lame excuses. "We don't know how to sell OTC products with age restrictions." Doze po widdle gurlz! We must pwotect dem from da horrow of Plan B overdose.

The risks associated with plan B for young teens is up for the producer, Barr, to research. Note that they haven't bothered to do a simple study (which could be as simple as going down to shopping malls and asking young girls a few questions about a label), and instead have asked that this pill only be OTC for 16+. Why is that? Hmm?

And I'm waiting for your brilliant ideas on how to sell OTC products with age restrictions too.

 

[BoberFett]

Originally posted by: shira
The panel that voted 23-4 in favor of approval knows the risks. Birth control pills are safe and effective, and all Plan B is is a triple-strength dose of birth control. Ohhhhhh. The DANGER. OOHHHHHH, the horror. Puleeeeeeeeeeeze!

Before you open your big, stupid mouth again, you should probably be told that many women can't safely take hormonal birth control. A triple dose could in fact be dangerous for some women.

That said, I see no reason that this shouldn't be sold OTC. The last thing this country needs is more undisciplined kids running around causing trouble. Anything that can slow our birth rate is good.

 

[Veramocor]

This almost deserves its own subject:


At worst Faux News blatently lies on the subject of Plan B. At best WebMD has gotten the story totally wrong.

http://www.foxnews.com/story/0,2933,167194,00.html

The problem isn't safety, says FDA Commissioner Lester Crawford, DVM, PhD. The agency is convinced the emergency contraceptive is safe for all women.

The problem, Crawford says, is that the FDA isn't convinced that women under the age of 17 can understand the product's instructions for use. That's why last year it rejected the full over-the-counter status requested by manufacturer Barr Pharmaceuticals.

Following that May 2004 refusal, Barr asked the FDA to approve Plan B for over-the-counter sale to women 16 and older. But the long-awaited decision on that request -- expected by the end of this month -- is once again on hold.

The main problem, Crawford said in a news conference, is how the FDA can enforce a rule restricting over-the-counter sale of Plan B to women 17 and older (the agency decided to up the age limit requested by Barr).

"There are unique regulatory issues that need to be addressed," Crawford said in a news conference. "We can only decide these issues in an open process. That will let us decide whether FDA can approve a drug for both over-the-counter and prescription use, for the same indication, sold in the same package."

Get the Facts About Emergency Contraception

Open for Public Comment

The FDA is opening a 60-day public comment period -- shorter than its usual 90- and 120-day comment periods. But Crawford would not commit to a timetable for making a decision after that period is over.

"I make the commitment we will ... ensure this process is expeditious and thorough," Crawford said. "Expediting this process will be a personal priority of mine."

In a statement, Barr expressed regret at the FDA's lack of action.

"We are disappointed that the FDA did not approve our application," Barr CEO Bruce L. Downey says in a news release. "While we believe that a delay is not justified, we will use the opportunity presented by the FDA proceedings to continue to press for approval of Plan B as an over-the-counter/prescription product."

Does 'Morning After' Pill Change Sex Habits?

What Plan B Is and Isn't

Plan B is an emergency contraceptive. That means it's supposed to be used only as a backup plan when a couple has unplanned sex or when other contraceptive methods fail.

Plan B is one of two approved emergency contraceptives. The other is Preven from Gynetics Inc. Gynetics has not asked for over-the-counter status, so today's FDA action -- or inaction -- applies only to Plan B.

Other contraceptives work by keeping a man's sperm from fertilizing a woman's egg. Depending on where a woman is in her menstrual cycle, emergency contraception may work the same way. But it is more likely to work after sperm fertilizes the egg.

Plan B helps keep a fertilized egg from implanting in a woman's womb. If Plan B fails and the egg implants, pregnancy proceeds normally.

Earlier this month, David M. Plourd, MD, told WebMD that Plan B is about 75% effective at preventing pregnancy after unprotected intercourse. Plourd is assistant professor of obstetrics and gynecology at Naval Medical Center in San Diego.

"Preventing pregnancy 75% of the time is less than almost every other form of contraception," Plourd said. "That is why it is plan B, not plan A."

The bold is a blatent lie (or mistake). It is the exact oppositte way around. Plan B will hardly ever prevent the impregnation of a fertilized egg. It manily works by preventing ovulation

 

[1EZduzit]

Originally posted by: zendari

Originally posted by: shira

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.

Heaven forbid some underage girl should want a pill to avoid getting pregnant. Somehow, minors getting cigs and alcohol hasn't spelled the end of civilization. How can the risks associated with Plan B pills be even a 100th of the risks of underage drinking? Yet alcohol is legal and Plan B is indefinitely on hold? Total crapola!

All this talk of the danger to minor girls is just BS. It's the anti-abortion radicals making lame excuses. "We don't know how to sell OTC products with age restrictions." Doze po widdle gurlz! We must pwotect dem from da horrow of Plan B overdose.

The risks associated with plan B for young teens is up for the producer, Barr, to research. Note that they haven't bothered to do a simple study (which could be as simple as going down to shopping malls and asking young girls a few questions about a label), and instead have asked that this pill only be OTC for 16+. Why is that? Hmm?

And I'm waiting for your brilliant ideas on how to sell OTC products with age restrictions too.

FDA's Decision Regarding Plan B: Questions and Answers

Now FDA has completed its review of the supplemental application and concluded that the application could not be approved at this time because 1) adequate data were not provided to support a conclusion that young adolescent women can safely use Plan B for emergency contraception without the professional supervision of a licensed practitioner and 2) a proposal from the sponsor to change the requested indication to allow for marketing of Plan B as a prescription-only product for women under 16 years of age and a nonprescription product for women 16 years and older was incomplete and inadequate for a full review. Therefore, FDA concluded that the application was not approvable.

It's no wonder that so many people can't afford health care. The doctors want them to have to pay for an office visit to get a perscription. It's going to cut into their fat wallets. The medical profession really is getting SICK!!

 

[Jhhnn]

From zendari-

"And I'm waiting for your brilliant ideas on how to sell OTC products with age restrictions too."

What sort of protected life have you been living? Never been to a convenience store, where they keep the cigarettes behind the counter? Maybe a liquor store, where they ID anybody under the age of 40? Adult bookstore, where the same story repeats itself?

The whole set of arguments from the fundie fringe reminds me of the fearmongering rationale for the invasion of Iraq... whatever grain of truth or faith they contain is buried under the hysteria, and the desire to run other people's lives...

 

[1EZduzit]

Originally posted by: Jhhnn
From zendari-

"And I'm waiting for your brilliant ideas on how to sell OTC products with age restrictions too."

What sort of protected life have you been living? Never been to a convenience store, where they keep the cigarettes behind the counter? Maybe a liquor store, where they ID anybody under the age of 40? Adult bookstore, where the same story repeats itself?

The whole set of arguments from the fundie fringe reminds me of the fearmongering rationale for the invasion of Iraq... whatever grain of truth or faith they contain is buried under the hysteria, and the desire to run other people's lives...

I've thought that many times myself, and I can only pray it doesn't go that deep.

 

[zendari]

Originally posted by: Jhhnn
From zendari-

"And I'm waiting for your brilliant ideas on how to sell OTC products with age restrictions too."

What sort of protected life have you been living? Never been to a convenience store, where they keep the cigarettes behind the counter? Maybe a liquor store, where they ID anybody under the age of 40? Adult bookstore, where the same story repeats itself?

Too bad none of that works.

It's no wonder that so many people can't afford health care. The doctors want them to have to pay for an office visit to get a perscription. It's going to cut into their fat wallets. The medical profession really is getting SICK!!

Funny then, because they aren't requiring adults to get a prescription anymore.

Nobody's forcing you to use the medical profession.

 

[Jhhnn]

Well, zendari, there's been no proof whatsoever that the product is harmful to anybody. Speculation, conjecture, innuendo and outright fearmongering, yes, but nothing more than that... which renders the whole age limitation argument moot, anyway. Any 14 year old who can handle tampons can probably take Plan B with the desired results... Aspirin can kill you, fer crissakes...

Interesting that you'd oppose this change on the basis that the controls mentioned above "don't work" in your rather limited estimation. If you were actually making a consistent argument, that statement would lead to a call for the legalization of all drugs, given that any savvy 17 year old can score dope a helluva lot easier than a 12 pack anywhere in America...

And, despite your apparent lack of reading comprehension, the decision puts all women in the position where they still need a prescription for Plan B- a wonderful thing when you had unplanned and unprotected sex friday night and the doc won't see you until monday, at the earliest...

The whole thing is just an extension of the sour grapes routine about birth control in general and abortion in particular being legal in this country. It throws the Fringe's shame-based morality off into the weeds, where it belongs. It'd be tough to preach against the sins of sex if there weren't any obvious victims, wouldn't it?

 

[zendari]

Originally posted by: Jhhnn
Well, zendari, there's been no proof whatsoever that the product is harmful to anybody. Speculation, conjecture, innuendo and outright fearmongering, yes, but nothing more than that... which renders the whole age limitation argument moot, anyway. Any 14 year old who can handle tampons can probably take Plan B with the desired results... Aspirin can kill you, fer crissakes...

So why can't Barr comply with the FDA demands and show that this product is safe for kids?

Interesting that you'd oppose this change on the basis that the controls mentioned above "don't work" in your rather limited estimation. If you were actually making a consistent argument, that statement would lead to a call for the legalization of all drugs, given that any savvy 17 year old can score dope a helluva lot easier than a 12 pack anywhere in America...

I prefer the legalization of drugs actually. They can be nicely taxed for revenue. I guess then it would be tougher to cry and point fingers when your 12 year old shoots up and drops dead.

 

[BaliBabyDoc]

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...

Curiously, the bolded section describes the majority of OTC drugs and 80%+ of prescription drugs.

Admittedly, when I was a young, impressionable (and Republican) . . . I wanted to be FDA Commissioner. David Kessler, arguably one of the architects of Big Tobacco's introduction to reality, ran the FDA as if it was responsible for protecting the "public" good. Those days are largely over. It's now thoroughly polluted with technocrats that think they serve Big Pharma and theocrats that will use any excuse to advance their agendas.

 

[zendari]

This decision hardly seems to be serving big pharma at all.

 

[BaliBabyDoc]

1) Don't EVER consider information from Faux News to be factual . . . except for the date, time of day, and the number of days in the "Aruba crisis."

2) Plan B is a contraceptive. Contraceptives typically work at ONE stage.
a) condoms - external physical barrier to sperm
b) diaphragm, IUD - internal physical barrier to sperm
c) spermicides (gel, foam) - internal toxic barrier to sperm
d) pill, patch, DepoProvera - chemical modification of ovulation cycle

e) Plan B - appears to mimick both the activity of IUDs and hormonal methods

3) Plan B works BETTER the SOONER you take it after unprotected sex. Even if you knew nothing about the mechanism, it would be safe to presume that Plan B is a highly effective contraceptive but NOT a good abortifacient (cause the loss of a fertilized, implanted zygote).

4) #3 highlights the need for Plan B to be readily available for ANYONE that has unprotected sex without an intent to procreate.

5) Controlling the access to OTC drugs is a ridiculous rationale considering we have known toxicities of OTC drugs but make few (often no) efforts to limit access. There's nothing special about Plan B. It's just another OTC drug that would be safe if used properly but likely carries risk if used inappropriately.

Until FDA mandates that all drug packaging be written at a 6th grade reading level while being short enough (in large print) that people would actually do so . . . the current Plan B controversy remains nothing but hypocrisy.

 

[BaliBabyDoc]

Originally posted by: zendari
This decision hardly seems to be serving big pharma at all.

Barr Labs isn't Big Pharma. At best I would call them . . . Little Pharma. I imagine most of Big Pharma is less than pleased that they no longer hold a monopoly on manipulating FDA.

 

[zendari]

Poor little pharma then I suppose. Liberals must be going nuts between their hatred of drug companies and their desire for sexual irresponsibility and promiscuity. Maybe Big Pharma should make this pill again to get on the libs good side.

 

[Don Vito Corleone]

Originally posted by: zendari
Poor little pharma then I suppose. Liberals must be going nuts between their hatred of drug companies and their desire for sexual irresponsibility and promiscuity. Maybe Big Pharma should make this pill again to get on the libs good side.

These sound distinctly like the words of a frustrated young man who can't get laid.

Women I've dated used the morning-after pill a couple of times, due to broken condoms. If anything, the pill caters primarily to people who are responsible, but who experience something like a condom failure - the truly irresponsible use no form of birth control, including the morning-after pill. Zendari, of course, appears to need neither, and to be proud of it.

 

[1EZduzit]

Originally posted by: zendari


Nobody's forcing you to use the medical profession.

LOL, I haven't been to see a doctor (or nurse) in almost 7 years and I see absolutley no reason someone should have to see a doctor to get Plan B medication either.

It seems you think you can force people to see a doctor though. Maybe you think young people should have to see a doctotr and get a prescription to get condoms also??

 

[Tommunist]

Originally posted by: zendari
Poor little pharma then I suppose. Liberals must be going nuts between their hatred of drug companies and their desire for sexual irresponsibility and promiscuity. Maybe Big Pharma should make this pill again to get on the libs good side.

oh man - there is no hope for you kiddo :laugh:

 

[shira]

Originally posted by: zendari
Poor little pharma then I suppose. Liberals must be going nuts between their hatred of drug companies and their desire for sexual irresponsibility and promiscuity. Maybe Big Pharma should make this pill again to get on the libs good side.

You apparently think that blocking OTC status for Plan B is going to change the fact that people are sexually irresposible and promiscuous. At least now you're being honest about the nature of your opposition to it.

The difference between a liberal and a knee-jerk conservative is that liberals accept the world as it is, and try to come up with solutions that make the best of the bad behavior of the human race.

True-believer righties, on the other hand, think we should pretend that people aren't people, and impose non-solutions that make the consequences of human fralities much worse. For example, you oppose needle-exchange programs - proven time and again to reduce the incidence of HIV infection (and, by the way, to save the public approximately $100,000 per AIDS case) without increasing drug usage - because you can't stand the idea that ANY public program should cater to immoral behavior.

Opposition to Plan B is just another example of the right-wing, rabid desire to impose morality. The arguments against OTC status for Plan B are meaningless drivel.

 

[BoberFett]

Originally posted by: shira
The difference between a liberal and a knee-jerk conservative is that liberals accept the world as it is, and try to come up with solutions that make the best of the bad behavior of the human race.

That's one of the biggest loads of bullsh!t I've ever heard. First, nice sucker punch with the "knee-jerk" comment. Second, if liberals accept the world as it is, why are they constantly trying to force people to change? Hate smokers? Go after tobacco companies and force smokers to stop. Hate fat people? Go after fast food. American liberals and conservatives alike want nothing other than an army of drones that think and act like they do. Accept the world as it is. What a load of crap.

True-believer righties, on the other hand, think we should pretend that people aren't people, and impose non-solutions that make the consequences of human fralities much worse. For example, you oppose needle-exchange programs - proven time and again to reduce the incidence of HIV infection (and, by the way, to save the public approximately $100,000 per AIDS case) without increasing drug usage - because you can't stand the idea that ANY public program should cater to immoral behavior.

If you hypocritical liberals would simply work to legalize drugs and other victimless crimes, you wouldn't have to have layer after layer of botched government programs. Somehow you see needle exchange programs as compassionate, yet you still think drugs should be illegal and underground. Hypocrites.

Opposition to Plan B is just another example of the right-wing, rabid desire to impose morality. The arguments against OTC status for Plan B are meaningless drivel.

Right, because the left never attempts to impose their own morality. :roll:

Get a clue.

 

[SMOGZINN]

Originally posted by: zendari
No, we come up with a system to better prevent minors from obtaining alcohol. Or in this case a system to prevent minors from obtaining a pill without a prescription, at least until the risks of emergeny contraception to adolescents have been adequately studied.

Have any ideas?

Yes, how about putting a big red and yellow lable on the box that reads, "IF YOU ARE UNDER 16 THIS COULD KILL YOU!" and then consider it a public service if some teens die from it.

 

[zendari]

Originally posted by: shira

Originally posted by: zendari
Poor little pharma then I suppose. Liberals must be going nuts between their hatred of drug companies and their desire for sexual irresponsibility and promiscuity. Maybe Big Pharma should make this pill again to get on the libs good side.

For example, you oppose needle-exchange programs - proven time and again to reduce the incidence of HIV infection (and, by the way, to save the public approximately $100,000 per AIDS case) without increasing drug usage - because you can't stand the idea that ANY public program should cater to immoral behavior.

The true problem with this scenario is the public funding for people with aids, not the potential needle exchange program. I don't have a problem with druggies self-exterminating themselves if the government wouldn't insist on picking up the bill.