Breaking news: FDA rolls – will approve morning-after pill sales for 17-year-olds
From Fox News, today:
The Food and Drug Administration, reversing field, will now let 17-year-olds get the ‘morning-after’ birth control pill without a doctor’s prescription….
[An] official, who spoke on condition of anonymity, said the agency will announce that it is complying with a federal judge’s order that overturns a Bush administration policy. The official was not authorized to speak publicly before the FDA announcement, expected later Wednesday….
Last month, U.S. District Judge Edward Korman ruled in a NY lawsuit that Bush administration appointees let politics, not science, drive their decision to allow over-the-counter access to these pills only for women 18 and older. Korman ordered the agency to let 17-year-olds get the medication, and separately to evaluate whether all age restrictions should be lifted….
What is happening here is judges, not science, are now driving FDA decisions. In days past, the FDA would fight such an outrageous unscientific, nonmedical imposition on its authority. But the Obama administration, of course, agrees minor girls and boys should have access to this megadose of female hormones, for which no long term studies have been completed, and which can cause abortions.
[HT: Claude and Kristina]
Jill Stanek is a nurse turned speaker, columnist and blogger, a national figure in the effort to protect both preborn and postborn innocent human life.
So a 17 year old can’t vote, buy alcohol or cigarettes, but they can buy this pill which can cause abortion or possibly cause other side effects we don’t know about? And this appears to be without parental consent or knowledge?
Even more chilling is the possibility of them removing age restrictions at all.
This is the beginning. The government will be practicing medicine and your doc will be told by the state what is best for you. He will have to call washington to reat you. (unless you are too old)
This is appalling. Obama’s girls could be molested, given a pill by the molester and no one would ever have to know It could happen to ANY child.
And what about fifteen, sixteen, seventeen year-olds having sex? Is this a good thing to be facilitating? Shouldn’t they be concentrating on developing their brains at that age, not their sex-lives?
What is happening here is judges, not science, are now driving FDA decisions.
Science never drove the FDA decision on Plan B. It was restricted to adults purely for political reasons, as the court has found. There is no scientific reason whatsoever to allow free access to 18-year-olds but not 17-year-olds. Now that the Bush administration is gone, the FDA is free to act according to science.
Plan B is extremely safe and does not cause abortions. By preventing unwanted pregnancies, it prevents abortions.
Obama’s girls could be molested, given a pill by the molester and no one would ever have to know It could happen to ANY child.
Molesters and rapists can (and HAVE) use condoms, which are available at any pharmacy, gas station or men’s restroom, and avoid pregnancy as well as leaving DNA evidence. Yet I don’t hear pro-lifers demanding that condoms be made prescription-only. Why the hypocrisy?
“There is no scientific reason whatsoever to allow free access to 18-year-olds but not 17-year-olds.”
Huh? What would be an example of a scientific reason why one group of people should be allowed free access to something while another group can not? Make sure it’s a scientific one!
@ Bobby: Certain medications for mental illness are key in keeping conditions such as bipolar, schizophrenia, etc. in control. Due to state-funded programs, many of these medications are available at low or no cost to qualified residents with these conditions. Elderly citizens with dementia were previously provided these medications under similar conditions. However, it was recently discovered that these medications could make dementia worse. Thus, free for one group, but not for another.
http://www.ucsusa.org/scientific_integrity/abuses_of_science/emergency-contraception.html
Science Overruled on Emergency Contraception
In its decision not to approve the emergency contraceptive drug Plan B for over-the-counter use, the FDA cited scientifically dubious concerns about the drug’s effect on adolescent girls—a position backed by some social conservatives who argue that easier access to emergency contraception would encourage promiscuity in young women.
An official at the Food and Drug Administration (FDA) overruled the advice of the agency’s staff and two independent scientific advisory panels when he decided to deny women over-the-counter access to the emergency contraceptive levonorgestrel (sold under the brand name “Plan B”). Numerous FDA officials and medical advisers to FDA involved in and familiar with the approval process call the move an almost unprecedented repudiation of government scientific expertise. By law, the FDA is required to approve drugs that are found to be safe and effective.
In the case, Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research, acknowledged to reporters that he overturned the recommendations of his own staff and two FDA advisory panels in declaring the drug “not approvable” for nonprescription status. A joint meeting of two independent FDA scientific advisory committees voted 23 to 4 in December 2003 to recommend the emergency contraceptive as an over-the-counter drug. The panel also voted unanimously that the drug could be safely sold over the counter.
…
James Trussell, director of the Office of Population Research at Princeton University and a member of one of the FDA advisory committees that recommended the drug’s approval for over-the-counter sale, says that after hearing many hours of testimony and reviewing thousands of pages of medical literature, “[O]ur committee had absolutely no concern about the use of this drug by young girls.” Advisory committee member Dr. Julie Johnson, a professor of pharmacy in Gainesville, Florida, touted Plan B to be the safest product the committee had reviewed in several years.
…
Nonetheless, Dr. Galson broke with agency protocol by overruling FDA staff scientists who had concluded that this drug met FDA criteria for nonprescription status and overwhelmingly recommended the switch. In overruling his staff and the advisory committee, Galson offered no substantial new evidence, and took the unusual step of writing the official response to the drug company himself.
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There is absolutely no scientific basis for denying young girls over-the-counter access to Plan B. It should be on the shelf next to the condoms, available for purchase by anyone who needs it, regardless of age.
This is getting more disgusting every day. All a girl has to do is LIE about her age (how do you think teens manage to buy cigarettes? They either get them from an 18+ year old or they LIE about their age).
And do you really think sexual predators are going to stop at the gas station and pick up a package of “protection”? Yeah RIGHT!
Teens should not be having sex.
But HA, how is that a scientific answer? When you stated
“it was recently discovered that these medications could make dementia worse.”
this was an ethical statement; a claim that having worse dementia is somehow less desirable.
But obviously your explanation makes sense. It’s just that reality tried to make it sound like this was purely about science, when of course, it has always been an ethical question.
Liz,
And do you really think sexual predators are going to stop at the gas station and pick up a package of “protection”? Yeah RIGHT!
Rapists HAVE, in fact, used condoms during rapes.
http://www.nytimes.com/1994/08/22/nyregion/rapists-and-condoms-is-use-a-cavalier-act-or-a-way-to-avoid-disease-and-arrest.html?sec=health
“Five years ago investigators would have been surprised by a victim’s statement that her assailant used a condom. Today detectives, prosecutors and counselors say that it is no longer unusual.
“Condoms could prevent a victim from becoming pregnant or infected with a sexually transmitted disease, but prosecutors say they also make it harder to convict rapists. With a condom, the attacker can take the evidence with him, making the job of the prosecutor, who has no access to semen from which to take DNA samples, more complicated.
“Marilyn Lewis, head of the San Francisco Rape Treatment Center, a city agency, said that 15 to 20 percent of her cases involve condom rape.”
So where are the pro-life calls for condoms to be made prescription-only?
Teens should not be having sex.
And yet they do, despite years of not having OTC access to Plan B.
How young is too young for Plan B, Reality?
I am just so darn encouraged that rapists use condoms. I am glad they take such a thoughtful step before they…rape.
Mr. Bambino, Reality wasnt saying this has anything to do with science. That was her whole point. It was Jill Sanek that was trying to say it does. It doesn’t. The FDA restriction was based on politics and personal beliefs.
“Marilyn Lewis, head of the San Francisco Rape Treatment Center, a city agency, said that 15 to 20 percent of her cases involve condom rape.”
If what you say is true about “condom rape”, this means 80-85% of her rape cases do NOT involve condom use, therefore the possibility of a young girl getting pregnant after molestation is still there.
Excellent Point, Janet!
Thanks, Liz.
My wife and I have five surviving children. Only one my youngest daughter is still a teenager.
For a few months all five were teenagers at the same time.
After living with my wife through five pregnancies, I believe I can correctly observe that pregnancy does not suddenly make women more mature, more responsible, more emotionally stable.
My observation is that if any thing the hormone shifts associated with pregnancsy make women less stable.
(Pregant women seem to make most men nervous even when they are not the father.)
At seventeen years of age males and females cannot enter into legally binding contracts, buy alchohol, consent to sex, consent to non-emergency medical treatment.
Why is it, in the case of ‘minor’ females, that being pregnant qualifies them to consent to elective surgery, absent parental notification or approval?
What is the rationale for suspending the legal precept that ‘minors’ cannot ‘consent’ when it involves ‘contraceptives’ and ‘elective’ abortion?
The minor female cannot legally consent to sex, but she can consent to elective surgery to terminate the pregnancy that resulted from the sex to which she could not legally consent?
It just seems illogical to make an exception to the age of majority laws when minor females are more emotionally unstable as the result of being pregnant.
Any feministas want a take a stab at addressing that glaring contradiction.
yor bro ken
Ken, in many states a 17 year old can indeed consent to sex, at least with other 17 year olds.
My concern is that teens will abuse it as a regular form of birth control which it is not intended to be or will become more dependent on it for birth control failures when it has limitations (must be taken w/in a certain time frame, will not be effective if taken too late in the woman’s cycle, etc.)
Which misuse may occur, leading to more unplanned pregnancies, especially without the component of a pharmacist or doctor giving instructions. Also, I question a high-dose hormone birth control pill being made available OTC when it has been determined unadvisable for health and saftey reasons to sell regular dose bcp OTC.
Speaking of, I definately think there was a political componant and ideology in pushing for EC to be made available OTC by “repro. rights” advocates and health and saftey studies were preformed as a formality to get the FDA’s approval.
Rachael, I was thinking that too: How can they sell Plan B over the counter when they don’t sell the bcp over the counter? That will absolutely, positively lead to it being used as birth control on a semi-regular basis, and I think that using it often could very likely have detrimental effects; regardless, we just don’t know what the effects of taking it several times per month or week would be. There is a reason that the bcps are now low-dose rather than high-dose: because of all the side-effects that the high-dose bcps have.
Ken:
I am much, much more emotionally stable when I’m pregnant. After the third week, anyway. Pregnancy hormones do wonderful things to my brain, and I spend almost 8 months in near-euphoria. I know I’m unusual, but it can’t be said pregnancy always makes women unstable. (The third week is tough, though).
Posted by: Hal at April 22, 2009 11:03 PM
Ken, in many states a 17 year old can indeed consent to sex, at least with other 17 year olds.
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Well Hal, if that is the case, then it is probably because neither party is considered an adult because neither party has reached the age of majority.
In most, if not all states, if one person is 18 or above regardless of their gender and the other is below 18, sex between the two is statutory rape, because a minor by a law cannot give his/consent to sex.
Female adult teachers have been found guilty of having sex with minor male students on multiple occasisons in recent years.
None of those 17 year old male students could consent to an elective surgical procedure like say a vasectomy.
But you already knew all that. You are an attorney.
yor bro ken
Posted by: reality at April 22, 2009 3:58 PM
Plan B is extremely safe and does not cause abortions.
By preventing unwanted pregnancies, it prevents abortions.
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No one ‘knows’ if Plan B is ‘extremely safe’ for the female who uses it. It has not been in use long enough to make that determination.
Plan B does not prevent ‘pregnancy’, it prevents implantation of the ovum.
It is not ‘extremely safe’ for the newly conceived child, it is the guarantee of a very short life.
The mother, by killing the child with a self administerd chemical/biological weapon, does eliminate the abortionist’s opportunity to kill the child.
Either way it does not reduce abortion because Plan B is an abortifacient.
Keep trying reality. The odds are you will get one right even if you never hear the ‘pop’.
yor bro ken
Posted by: Grant at April 22, 2009 6:34 PM
Mr. Bambino, Reality wasnt saying this has anything to do with science. That was her whole point. It was Jill Sanek that was trying to say it does. It doesn’t. The FDA restriction was based on politics and personal beliefs.
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Who is so naive as to believe that anything the a government agency does is based soley, or even primarily on science, reason and logic.
Government is inseparable from politcs as well as religion.
Even pbho has acknowledged that indisputable fact of life.
yor bro ken
Just to clearify, when I refer to a concern that Plan B will be over used and used in place of undesirable contraception (such as condoms), I’m not referring to a personal objection to BCPs (which I am not), I’m referring to the manufacturer’s instructions that EC should not take the place of regular contraceptive use.
“How can they sell Plan B over the counter when they don’t sell the bcp over the counter?”
Excellent point.
Could there be an ulterior political motive for pushing this drug? It’s not been in use very long; misuse is bound to cause future lawsuits when unexpected results occur; the drug company will lose millions in settlements and will become ripe for government takeover.
Ken, don’t argue law with me. Let’s pick our state of Washington shall we?
17 year olds can legally have sex with whoever they want. (16 year olds too)
RCW 9A.44.079
Rape of a child in the third degree.
(1) A person is guilty of rape of a child in the third degree when the person has sexual intercourse with another who is at least fourteen years old but less than sixteen years old and not married to the perpetrator and the perpetrator is at least forty-eight months older than the victim.
kbhvac science should be the driving force behind FDA restrictions. In the case of the restrictions placed on the morning after pill, it was not. The restrictions were driven by politics and personal beliefs. That is why these restrictions are being lifted. They were not based on science. A step in the right direction.
Why sell this over the counter and not birth control? There is the issue of expediency for the morning after pill to be effective in preventing pregnancy.