The next stage of the Plan B saga moves to the courts. Even before last week’s controversial decision keeping the morning-after pill behind the pharmacist’s counter, and requiring women under 17 to secure a prescription before purchase, a coalition led by the Center for Reproductive Rights planned to take the government to court over age restrictions for the drug. Today, that hearing takes place.
The Center for Reproductive Rights and other groups have argued that contraceptives are being held to a different and non-scientific standard than other drugs and that politics has played a role in decision making. Social conservatives have said the pill is tantamount to abortion.
Judge Edward Korman was highly critical of the government’s handling of the issue when he ordered the FDA two years ago to let 17-year-olds obtain the medication. At the time, he accused the government of letting “political considerations, delays and implausible justifications for decision-making” cloud the approval process.
In court papers prior to Wednesday’s hearing, Assistant U.S. Attorney Scott Landau said the government had complied with Korman’s orders by lowering the cutoff for over-the-counter sales of the drug from 18 to 17.
He said the plaintiffs “unfairly accuse FDA of bad faith and delay.”
The fact that this is the same judge who altered FDA guidelines on Plan B previously should give some hope that he will respond favorably to this request. The result of the order could eliminate the need for a prescription for Plan B among teenage girls, although I’m not sure whether the judge could force the drug onto the counter.
Health and Human Services Secretary Kathleen Sebelius defended her actions to restrict Plan B, claiming that her objections were scientific and not political, due to a “large missing piece of the puzzle” in the data. This suggests the issue could be taken up again, but of course the idea that the data was inconclusive is highly suspect: FDA researchers worked for years to determine the safety of Plan B for unrestricted use, on top of what the manufacturer of Plan B, Teva, provided.
And I suspect all of that data will be made available to Judge Korman today at trial. So it’s at least possible that, within a number of months, the restrictions will be lifted. Perhaps that was part of the calculus at the White House, that they could get the courts to institute this over their objections, so they didn’t have to take the heat for it. Of course, the restrictions were bad politics quite on their own, so that strategy makes little sense as well.





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I’m glad to see that CRR has succeeded in getting the matter into the Federal courts.
The Plan B decision is typical of Obama’s ability to “11 Dimensional Chess” his way into a situation that increases polarization and amplifies the political components of an issue – while also begging judicial rebuke. In this case, it’s looking like it could become a lose, lose, lose situation.
Well done Barry.
http://www.lawyersandsettlements.com/articles/yasmin-side-effects-yaz-blood/yasmin-birth-control-pill-yaz-side-effects-45-15369.html
Hmm? a legal FDA approved drug causes death but is anyone at the FDA pulling this drug?
http://www.msnbc.msn.com/id/8565177/
Is anyone at the FDA pulling this drug? Please note I am very pro birth control I think that if a Mom does not want a child that child’s life will be hell if she is forced to keep the child. I have seen to many marriages formed because a woman wanted to keep a guy and thought a child was the way to do it.
I have seen women be right that having a child made her boyfriend step up do the right thing marry her, get a job, stop partying but I’ve also seen many cases where the woman was wrong…very wrong.
If a woman decides on her own that she does not want a child, that the father either won’t step up or is just a jerk she wants nothing to do with, or she is not ready for a child who is church, society and government to tell her she has to have a child?
Does the church, society or government claim too know better than the woman her own personal situation?
Does the church, society or government want to really claim that people should get married when they first have
sex?
I heard the morning after pill costs $50 a pop can anyone claim that in this economy kids will have more sex because they now can get the morning after pill?
I must ask if all these new birth control pills that cause death but were FDA approved approved because safer older birth control was going to lose its patent protection and the drug makers wanted a new product they could charge more money for.
The central question is given the price of the morning after pill will it really cause more deaths than other not only birth birth control medicine but other FDA approved drugs? Everytime I turn on the tv I see all kinds of medicine advertised where they mention it may cause death these days. This is often not medicine for life threatening illness but rather minor conditions.
Its hard to see the FDA argue that patient safety was the main concern in banning the morning after pill when so many other life threatening drugs were approved.
I wonder if any members of congress, the WH or FDA officials bought stock in other birth control makers ahead of the news that the Morning After Pill would be banned?
Given the interest the GOP has in birth control I would expect many of them to be in the loop on this. It would be quite embarrassing to the GOP if any prolifers bought stock ahead of the news the FDA would ban the morning after pill. It would be double embarrassing for Dems.
For prolife Dems who prolifers do not trust on birth control anyway in purple districts such news could lose elections.
What a person says is telling when a person says something but does another thing we assume he is lying, that he does not mean what he says.
What a person lies about and why he lies is telling a person wants something but does not think the truth will get him what he wants.
What a person is silent about is also telling it means they either don’t care, don’t know, or some force fear usually is acting upon them to compel their silence.
Jesus’s silence on abortion is telling. Its not like he was unaware of the practice Greek, and Roman medicine was quite aware of birth control and abortion. (facts listed at end of article)
Riddle then discusses at length the abundant but neglected evidence in Dioskorides and Soranos (16-56) for herbal (oral) contraceptives (ATO/KIA) and abortifacients (FQO/RIA). These chapters ought to be required reading for those who believe that the conceptual world of Greek medicine is wholly alien to and disjoint from ours. First, laws and precepts from Plato to Talmud show that ancient people believed that oral contraceptives worked to reduce fertility (16-20), and they distinguished contraception from abortion (20-24). Riddle evaluates the prescriptions of Soranos 1.61-3 by reference to numerous modern pharmacologic studies which show that nearly every plant claimed as contraceptive by Soranos and which has been tested, in fact works
From Hippokrates to Galen, Greek medical writings contain a variety of contraceptive prescriptions, whose known ingredients when tested show anti-fertility effects (74-86). Such knowledge was acquired in the same way that we have learned over centuries and millennia which plants are edible, cure headache or heart trouble, etc. (87). Observations of low fertility in animals by herders allowed further discoveries (88). In the Late Roman Empire and Early Middle Ages the tradition survived, albeit weakened, in standard medical texts (89-107). The difficulty was the Roman Church’s well-known opposition to abortion and contraception: yet in Macer’s influential XI-A.D. herbal, pennyroyal is still given as a birth control herb (108-117).
http://bmcr.brynmawr.edu/1993/04.04.08.html
http://my.firedoglake.com/thingscomeundone/2011/07/23/sunday-preaching-the-silence-of-jesus-on-abortion/
My bold we have had morning after herbs since Roman times people watch the sheep and goats eat a weed and then either not give birth or have a miscarriage. Until the Roman Catholic church got into power morning after herbs were standard medical treatment.
Political considerations then like now made such knowledge illegal. Never mind Jesus said nothing about abortion and it was a common practice back then. Every sheep, goat etc herder knew which plants there animals should not eat if they wanted their herds to grow. So Yes Jesus knew about abortion but said nothing.
Before any prolifers bring up the Didache an Ethiopian church book to support their position I must remind you the Didache does argue against abortion but I have yet to find a commentor to bring a link saying and Jesus said.
So there is no direct quote from JC on this matter. Plus none of the other christen church’s accept the Didache as a holy book.
http://faculty.cua.edu/…
Surely 5th Century St. Augustine the Authority on theology and St. Thomas Aquinas both of whom are still taught at Catholic schools are the authority on this matter.
Fine if your religious and have sex outside of marriage do penance but there is no need for additional penance for abortion.
Sebelius holds what science based credentials?
Dude, I betcha money that more people have died from Tylenol than they have from Yaz and it’s still on the market. So what is your point? Do you feel all drugs should be pulled from OTC status? Almost any medication given the right conditions can cause death whether it be motrin or plan b. That’s the downside of actually taking a medication.
Surely, the goal should be, NO UNWANTED BABIES?”
The anti-abortion following says they want to save lives.
So the 16 year old girl has a baby she is unable to care for (but must) and the result is an unwanted child
that is not only destructive to the mother but a drain on society, who must take care of the child.
Jon Carroll has a fine piece on this topic in the SF Chronicle this morning: http://www.sfgate.com/columnists/carroll/
Ding!
The old ones cause clots too. That’s why if you are female and they are screening you for the pill they’ll ask if you have a family history of heart attack,strokes, or migraines and ask if you’re a smoker.
Look up ortho novum(an old pill) and you’ll see the side effects are very similar to the new pills. It does say the drosperinone seemed to have a higher probability of clots but the same panel that acknowledges it also said that the benefits of the drug outweighed the risk for Yaz. They also pointed out that the risk is small.
http://www.usatoday.com/money/industries/health/story/2011-12-05/FDA-revisits-safety-of-newer-birth-control-drugs/51654030/1
The stats on risk indicate the difference between the older BCP risk of a clot is 6 in 10,000 and the newer ones are 10 in 10,000. While there is in an increase in risk, with problems such as obesity which also increase prevalence in health problems make it incredibly hard to factor whether the drug is the problem or if it is an increase in problems due to other factors.
I’m as cynical as the next guy but I think that these numbers don’t bear out the FDA as the bad guy.
I’ve argued for years that the way to break off a core of voters from the right is to argue from an economic viewpoint. Unwanted and unplanned for children cost money. If the parents are unable to pay for their basic essentials and schooling then everyone else pays in the form of higher taxes to support these kids and social programs. If conservatives hate social programs so darn much then they ought to be cheering at the idea of giving people unready to deal with the obligations being a parent entails access to reproductive measures that prevent unwanted births.
Assuming rational thought process, not in evidence.
Dude my point is science is based on Objective Standards I assume causing death or harm to people is the standard.
Since the FDA already approved birth control that kills people then maybe the question should how many deaths or how much harm to people is ok according to the FDA’s standards?
The argument that teens will abuse a $50 a pop drug when they were to cheap to buy condoms is laugh out loud funny.
The argument that teens having sex will use the drug after every time they have sex at $50 a pop is even more funny.
I just want the FDA to try and justify their decision based on science and their own rather lax standards.
I do wonder why these new birth control pills got approved when they don’t seem as safe as older birth control pills.
I do suspect patents on older birth control expired and the drug companies wanted more profits which the get with new drugs under patent.
I wonder if the FDA relaxed their standards to let the drug companies make more money.
The numbers for the morning after pill vs current or older safer birth control would be interesting. The argument young girls will abuse the morning after pill at $50 a pop which the WH put forward are a joke.
Assuming rational thought process, not in evidence.
The heart is not rational reasons change desire remains the same. They want to oppress women by restricting sex concerns about pregnant moms are a joke some Red States have infant mortality rates that belong in third world countries.
If its a choice between private charity which the Red States give more than the Blue or the Blue States paying more taxes to care for Pregnant moms the evidence is clear government does work better than private charity.
But the Fundies I agree do not care about facts.
I no longer care to repeat the overwhelming evidence that it is about controlling women’s bodies, that fundies don’t give a ff about life.
I can’t bear to let the GOPers try and get away with such weak lies:)
Penicillin kills a number of people. My point is that the FDA is set up to look at the benefits and the risks associated with a medication, if the criteria were that someone might die then we’d not have any drug access at all.
I’m going to contrast the numbers on birth control which were 6 and 10 in 10,000 respectively with this information on Tylenol, a popular OVER THE COUNTER that has been around for ages. Accidental poisoning from it leads to approximately 400 deaths per year and 42,000 hospitalizations.
http://fauquierent.blogspot.com/2009/11/taking-tylenol-and-ibuprofen-also-has.html
Oh and before we go all critique-y on the FDA on that they actually reviewed and lowered recommendations on safe levels of Tylenol.
Penicillin kills a number of people. My point is that the FDA is set up to look at the benefits and the risks associated with a medication, if the criteria were that someone might die then we’d not have any drug access at all.
How many people die from drugs not only birth control that are FDA approved? How many die from the morning after pill is the question?
The WH has based its argument on young kids using the morning after pill to much given its price that argument is a joke.
I will concede if we get numbers that show the morning after pill is worse than what ever the FDa’s standards are.
Regulatory agencies, that have always been captured by their regulees to one degree or another, have become laughing out loud jokes, being continuously degraded under every administration, at least from Reagan.
I was a pharm tech in the Navy. We used to debate the FDA pretty regularly, in particular the abuse of fast tracking. That being said, I think alot of what we see today in terms of more side effects is also a result of better and more accurate reporting results.
For all the things I see the FDA do wrong, I also see them do right. (See Seldane or Darvocet which had safer and more effective replacements and were pulled from the market)
Thanks for your expertise.
If there is better & more accurate reporting of side effects, I’d be appreciative. This is not my area of expertise, but through general economics models (Stigler’s seminal work on regulatory capture), my personal decision on whether to use ritalin for my son when he was 8, 22 years ago (ritalin had been in use for 50 years, but no long terms studies that I could find), and article I read about better reporting of adverse effects in Europe than in U.S., I assumed the worst.
Also, Ds & O are wholly owned by PhRMA. So plenty of a priori reasons to be suspicious.
Barack Obama is a guy interested in the graphics or political correctness of an issue.
He’s a guy who voted “present” and was provided cover by Planned Parenthood for his vote on choice. It’s no shock to me that this decision was made.
Oh and I’d agree that the argument was poorly done. Sebelius complaining that this product would be placed next to gum was ridiculous. This is more cost prohibitive than condoms and they don’t place those next to gum. Stupid, stupid, stupid.
Short version on PP.
Have a Houston friend who’s big supporter. Holiday party, heavily harassed by anti-choicers, blah blah blah…
I sent her a link to prior FDL post on this subject which included a sentence about how women were doormats to Ds. She initially said that PP didn’t want Plan B to become an issue during election season. When I emailed that was exactly what made women doormats forever, that election season was EXACTLY when to make a federal case of it, she finally agreed with me.
Geez.
And she is one of the more alert feminists and Ds I know.
The first — and last — time I took the birth control pill was in the early ’70s, when the hormone levels were about 10 times what they are now.
Had the first dizzy spell of my life, gained 10 pounds overnight, and achy legs, and got off it.
But a whole generation of women have been guinea pigs for hormonal birth control since, so they pretty much know cause and side effects, at this point.
Barrier methods worked for me, but when I was of reproductive age, I also had the option of legal abortion for much of my reproductive years, if it had been needed.
Abortion may be legal, but it’s difficult to access in large parts of this country, especially for teenagers.
Better a one-shot hormonal dose (likely less than I was getting, daily, in the early ’70s) than an abortion, or the much higher health risks of a pregnancy for a young girl.
Barack Obama is a guy interested in the graphics or political correctness of an issue.
Real good angle to look at the story he was provided cover.