Obama Administration Changes Strategy, Drops Age Restrictions For Morning After Pill
The Administration has accepted reality in its fight against a ruling that made the "morning after" pill available regardless of age.
The Obama Administration has decided to drop its appeal of the Federal District Court Judge’s decision striking down an FDA rule that restricted the availibility of Plan B and other “morning after” pills based on age. As a result, these pills will soon become available to women and girls of all ages:
WASHINGTON — The Obama administration has decided to stop trying to block over-the-counter availability of the best-known morning-after contraceptive pill for all women and girls, a move fraught with political repercussions for President Obama.
The government’s decision means that any woman or girl will soon be able to walk into a drugstore and buy the pill, Plan B One-Step, without a prescription.
The Justice Department had been fighting to prevent that outcome, but said late Monday afternoon that it would accept its losses in recent court rulings and begin putting into effect a judge’s order to have the Food and Drug Administration certify the drug for nonprescription use. In a letter to Judge Edward R. Korman of the United States District Court for the Eastern District of New York, the administration said it would comply with his demands.
The Justice Department appears to have concluded that it might lose its case with the appeals court and would have to decide whether to appeal to the Supreme Court. That would drastically elevate the debate over the politically delicate issue for Mr. Obama.
Women’s reproductive rights groups, who had sued the government to clear the way for broader distribution of the drug, cautiously hailed the decision as a significant moment in the battle over reproductive rights but said they remained skeptical until they saw details about how the change will be put into practice.
The drug prevents conception if taken within 72 hours after sexual intercourse.
“We will not rest in this fight until the morning-after pill is made available without delay and obstruction,” said Mara Verheyden-Hilliard, a lawyer and the executive director of the Partnership for Civil Justice Fund, which represented the plaintiffs in the case.
Cecile Richards, the president of Planned Parenthood said: “This is a huge breakthrough for access to birth control and a historic moment for women’s health and equity.”
The F.D.A. issued a statement Monday night saying that it planned to drop its appeal. “To comply with the order, the F.D.A. has asked the manufacturer of Plan B One-Step to submit a supplemental application seeking approval of the one-pill product to be made available O.T.C. without any such restrictions,” the statement said. “Once F.D.A. receives that supplemental application, the F.D.A. intends to approve it promptly.”
The decision is certain to anger abortion rights opponents, who oppose letting young girls have access to the drug without the involvement of a parent or a doctor. For Mr. Obama, the decision could rekindle a high-intensity, politically turbulent debate about contraceptives even as he is already dealing with a series of distracting controversies and national security leaks.
Mr. Obama had expressed personal concern about making the drug more broadly available last year and offered support to Kathleen Sebelius, his secretary of health and human services, when she blocked a decision by the F.D.A. that would have cleared the way for nonprescription distribution to all girls and women regardless of age. He said that as the father of two young girls, the idea of making the drug available to them without a prescription made him uncomfortable.
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In its letter to the court, the Justice Department outlined the procedural steps that the F.D.A. plans to take. It said the maker of Plan B One-Step, Teva Pharmaceuticals, has been asked to “promptly” file an application asking for no age or sales restrictions, and that the “F.D.A. will approve it without delay.”
Once that is done, the F.D.A. expects makers of generic versions of Plan B One-Step — the most popular of those is Next Choice One Dose — to ask for a similar arrangement. The F.D.A. will evaluate those requests, based on whether it decides to give Plan B One-Step any type of market exclusivity, but most likely generic pills will also eventually be available without restrictions.
The Justice Department said it would not remove restrictions from two-pill emergency contraceptives because it is concerned that young girls might not be able to adequately understand how to take two separate doses. But two-pill versions are a diminishing fraction of the market.
Sarah Kliff explains:
It starts with a decision that the United States Court of Appeals for the Second Circuit issued last week. In that ruling, a three-judge panel considered the administration’s request to temporarily hold off on allowing over-the-counter sales of emergency contraceptives to women of all ages, as federal judge Edward Korman had ordered on April 5.
The Department of Justice wanted to stay that ruling until the appeals court issued a ruling on the merits of its challenge.
Korman had ordered that two emergency contraceptives, Plan B and Plan B One-Step, be made available without prescription to all women and girls. The appeals court partially sided with the administration: It issued a stay for Plan B One-Step because of jurisdictional issues. The case that Korman initially heard dealt only with the two-pill product, not Plan B One-Step, which could put the one-pill product outside the scope of that particular case.
On the two-pill Plan B product, however, the three-judge panel refused the administration’s request for a stay. It would not allow its move to over-the-counter to be delayed.
That meant two things. First, it was a signal that Justice would likely lose its appeal. Stays are typically granted when the appeals court sees a good chance for the challenger to ultimately prevail. In this case, the Second Circuit did not see that.
Second, the ruling meant that the two-pill Plan B product now had to move in front of the counter. According to the senior official, there was worry about the two-pill product proving too complex for young girls to use it properly. The newer Plan B One-Step, which contains a one-pill dosage of levonorgesterl, is easier to use, which the administration thought made it a safer over-the-counter product.
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In the administration’s best-case scenario, it would have won the stays and ultimately prevailed on appeal. That didn’t happen. The Department of Justice fell back on what the administration saw as the better of two undesirable options. That’s what you saw happen Monday, when Justice announced its intention to drop its appeals.
If nothing else, the ruling on the Administration’s request for a stay was a pretty strong signal that the Appeals Court was unlikely to overrule Judge Korman’s decision, which he had reached after a long hearing on the scientific merits of the FDA rule that restricted access to the over-the-counter version of the pill to females over 17. As As I noted at the time, this and the fact that Korman made his decision heavily dependent upon the factual findings he made after that hearings, made the decision difficult to attack on appeal. The FDA seemed to at least partially concede to the Judge’s argument last month when it modified its own rule to make Plan B One Step available to girls as young as 15.
The reactions to this are about what you’d expect. On the left, there is general support for the decision albeit some complaining that the Administration was trying to block access to the drug in the first place. On the right, the reactions are about what you’d expect as well. One blogger saying that the Administration wants to give the morning after pill to five year-old girls, a statement that is both ignorant and absurd on its face. Another conservative, meanwhile, is saying that the Administration obviously wants teenagers to have sex.
Reality, it seems to me, is quite different. Whether adults like it or not, teenagers are going to have sex just as they have been for generations. Ideally, they’d be using contraceptives when they do, but that’s not always the case unfortunately. What would conservatives prefer, a teenage girl who had unprotected sex but was able to take the Plan B and prevent an unwanted pregnancy, or a pregnant teenager that may turn into an unwed teen mother? It seems blindingly obvious to me that the first situation is better than the first. Moreover, the science behind this issue seems fairly well-established in that there is no evidence that allowing teenagers to take Plan B or other similar drugs would be harmful in any way. The other reaction that this story brings up, of course, is that it makes people uncomfortable to think that 15 year olds, and younger, can get access to this drug without their parents ever knowing. While that may be true, it’s not a factor that either FDA or the Department of Health and Human Services can rightfully consider. So, the only reason to block them from having access to the pill would seem to be based on moralism, and bad public policy, rather than on the science that is supposed to be the sole criteria that the FDA evaluates drugs. That, in the end, is the reason that the Justice Department lost in the District Court, and why it likely would have lost on appeal.
Update: Another conservative, Bryan Preston at PJ Media, argues that this decision will help to cover up statutory rape:
A 13-year-old girl who goes to the pharmacy to obtain the morning-after pill is probably the victim of a crime. She may be under threat, and walking into the pharmacy to get the pill because an adult has forced her into sex and is now forcing her to get medication that can help cover up the crime. Her parents have the right to know that their daughter is either wittingly sexually active or has been victimized. But no questions will be asked. The girl — not woman, girl — will not be asked to provide ID or any evidence of age. Her parents will probably never know.
This strikes me as largely scare mongering. A 13 year old buying Plan B is not, in and of itself, evidence of anything. She could have had sex with a boy her age, or only slightly older. Indeed, in many states, sexual relations between older and younger teenagers is not illegal as long as both parties are under 18 and there is not more than (usually) a four year age difference between the parties.
It does bring up another point, though. As I noted last month, Congress could still step in regarding this matter:
[I]t is entirely possible for Congress to take control of this issue by passing a law directing the FDA to require a prescription for minors who want this medication, although that’s unlikely to happen in the current political climate.
Similar legislation may also be possible at the state level. Whether it will survive court challenges is something I cannot speak to, but I do expect some legislators to give suh legislation a try.
It is also blindingly obvious that that is not what conservatives want.
Booman thinks this was 11-dimensional chess.
I agree. Unfortunately, Doug , your friends the Republicans would have gone apesh!t over this had the administration just gone along with the original FDA recommendation. You know it, I know it, and everyone who posts here knows it too. And the original recommendation came out in 2011, when the Tea Party looked a lot stronger and more credible. The Administration played defense until things looked better politically, and then they decided to let the FDA’s original proposal go forward-and in 2013, not in the election year. Well played , Obama Administration.
Yes because “If my teenage daughter has access to a penis I should know it! By God! Especially if it is a black penis!”
I gather the price is about $40 which means Teva Pharmaceutical is going to make a lot of money.
Humans shall engage in sexual intercourse in the missionary position only after they are married in the Holy Roller Church, a man to a woman, for the sole purpose of creating more conservatives.
(And if they enjoy it they will go straight to Hell!)
Of course those same anti-choice zealots would also limit the social safety net available to those who are denied access, as well as education funding, etc. Because…well…that’s how zealots operate.
@walt moffett:
A price tag of $40 pretty much puts it out of the reach of a very young girl from impoverished circumstances, doesn’t it?
Rightly so. Sooner young girls take that than have an unwanted pregnancy. It’s 2013 not 1776 anyway! And no Sarah Palin abstinence doesn’t work. Just look at your own daughter who you paraded around proudly while she was pregnant as you were spouting abstinence for others!!!
A ten year old girl has to have parental permission to go on a field trip, get a library card, watch a pg rated movie at school, and buy certain medications for colds. But not for some sort of birth control medicene. This should certainly be under the province of the parents. If their parent is ok with it, fine. Our local drug store says that they will have nothing to do with this, regardless of what some judge or Secretary Sebellius says. Next thing you know the schools will be giving this stuff out. We are talking about children here, not teens. Parents are seeing their authority taken more and more by the state. Even worse is that many parents are willingly abdicating their responsibilities over to the government. I certainly understand that there may be some situations in which this would become necessary, but to have this medicene available otc to anyone is totally warped.
The judge that is responsible for this needs to resign. This is further proof that this country is in steep moral decline.
@Tyrell:
I have teenagers, a boy and a girl, and the government has done nothing to remove my authority over them.
And if the country is in steep moral decline, perhaps you could explain why teen pregnancy rates are down.
@Tyrell: Most of the things you mention are to protect those organizations.
@Tyrell:
If you don’t want your child to purchase this product, than why don’t you act like F@$%ING parent and make sure they don’t? You complain about the government getting in the way with parenting, but you’re actually asking for exactly that. You WANT the government to interpose itself and prohibit children from buying this product. You are talking out both sides of your mouth.
If my underage teenage daughter had unprotected sex, I’d much rather that this option be there than not.
The Great Secular State, the USA has been in a moral nosedive ever since.
@Tyrell:
Any mother and father can tell their child that they are not allowed to buy the plan b pill. The government is not stopping proper parenting.
So are you the type of parent that needs the nanny state to step in an enforce what you as a parent should be doing anyway?
@stonetools:
Based on the reporting that Obama perosnally still opposes the decision but was talked into not fighting because DOJ didn’t think they could win, I think it was more Obama being the father of girls. He, personally, would want to know hence his opposition.
Silly Doug. Obviously, conservatives prefer the unwed teenage mother. Not only does it punish the slut for daring to have sex, it also serves as an object lesson for other teenage girls who might dare to do so.
@Tyrell:
So if you don’t want your daughter to purchase this, use your parental authority and forbid it. I’m sure that whatever you say, she’ll do, right?
But no, you want the government to forbid her from buying it. You want the big bad federal government to tell all pharmacists that they’re not allowed to sell this drug to teenage girls.
I tell you what, instead of relying on the government to do everything for you, why don’t you try taking some responsibility for a change? Just tell your daughter she’s not allowed to buy it and that if she has sex, she has to get pregnant and carry the baby to term, and that’s that.
@SKI:
Could Obama’s personal view have played a part? Sure. But when a decision plays out so well politically, you have to assume that political planning played a role.
Consider Tyrell’s response. Forget about how popular it is on this site. There are a gajillion voters out there who think just like him. Had the Administration embraced the FDA proposal back in , those voters could easily have been motivated to vote against Obama on this one issue. After all, they’re protecting their girls!
By resisting, the Obama Administration pushed this issue into a non-election year, AND gained brownie points for standing up for “parental rights.”
Now when Republicans run on this in 2014, as they surely will, they can’t run against Obama or the Democrats . A commenter on Balloon Juice said it all:
Bullet dodged.
Never let the facts get in the way of stonetools adoration of the Obama Administration. The Obama Administration decided on May 1, 2013 to challenge the judge’s ruling.o apparently those who disagreed were going to back in time and change their vote and “helped assure that the controversy didn’t galvanize Obama’s opponents in an election year.”
That 11th dimmensional chess game actually had a presidential election scheduled for 2013? or is stonetools just a tool for anyone with a “D” after their name?
@CSK:
Or the young girl with a minimal allowance. No doubt next will be the call for a government subsidy of some sort for those who lack insurance (or can’t get M&P to cough up the insurance card). Hmm maybe
I wonder is there any been any testing on adolescent women. Many prescription medicines are limits to 18 and older because the drug company never bothered to pay for pediatric/adolescent testing. Yet, now we have progressives who claim to be data driven and who claim to support the rule of law pushing for a government policy that is probably not based on science or testing.
I guess when it becomes between their political agenda and the existing government policy, progressives will go with their agenda.
I don’t even know how I ended up here, but I thought this post was great. I do not know who you are but certainly you’re going to a famous blogger if you aren’t already 😉 Cheers!
I don’t have much problem with this morning after pill. I am just concern with selling these over the counter pregnancy prevention drugs. I just hope that there are age limitations for this so that teenagers will also learn to be responsible with their actions.