The Obama administration filed its expected appeal on Monday of a judge's order to make the so-called "morning-after pill" available to anyone, without a prescription.

The federal government asked the 2nd U.S. Circuit Court of Appeals in New York to postpone federal judge Edward Korman’s ruling against the Health and Human Services Department’s requirement that anyone under 17 get a prescription for the emergency contraception.

Korman refused on Friday to stay his ruling while the appeals court considered the appeal, calling the government’s legal attempts “frivolous” and saying they were done in bad faith.

Women’s health groups had sued against the HHS decision, which had overruled the Food and Drug Administration’s original approval of Plan B birth control pills for women and girls of all ages. HHS Secretary Kathleen Sebelius had said she wasn’t comfortable seeing the pills freely available to girls as young as 11.

The FDA, which had protected against Sebelius’s decision, last month approved another drug application to make one brand available over the counter to girls as young as 15, but still requiring proof of age.

Korman railed against both decisions and has accused the government of simply trying to delay the inevitable.

For now, things are a bit confusing. The appeal, technically filed by the Food and Drug Administration, asks the appeals court to stop Korman's ruling from taking effect until the case is settled.

Teva Pharmaceutical’s single-pill option, called Plan B One-Step, is available with ID to anyone 15 and older. Anyone younger needs a prescription to get it.

Other versions of the medication are available to anyone 17 and older with proof of age, and to anyone younger with a prescription.

"You have to show an ID either way," said Judy Waxman of the National Women's Law Center. Waxman  predicts the appeals court will stay Korman's decision until a hearing can be scheduled on the appeal. "This could take months again until we get the Second Circuit decision," Waxman said in a telephone interview.

Related:

Judge refuses to delay Plan B ruling, has choice words for HHS

Judge: Make 'morning-after pill' available to all girls without prescription

By Toni Clarke
Reuters

A federal judge criticized the U.S. Food and Drug Administration over its refusal to make emergency contraception available to girls of all ages without a prescription, saying the agency's move to restrict distribution to consumers aged 15 and older was not realistic. 

U.S. District Judge Edward Korman on April 5 ordered the FDA to lift age restrictions on all levonorgestrel-based emergency contraception - also known as the "morning-after" pill or "Plan B" - to prevent unwanted pregnancies.

At a hearing in Brooklyn, New York, on Tuesday, he said he would rule by the end of the week on the FDA's request to stay the order, which is slated to take effect May 10. The FDA has appealed the ruling to the 2nd U.S. Circuit Court of Appeals in Manhattan.

"I do think there is a principle that is a dangerous one of a court ordering the FDA to approve a drug," FDA Commissioner Margaret Hamburg told the Reuters Health Summit in New York on Monday ahead of the hearing. "You have to step back and look at this not just in terms of Plan B but in terms of the precedent."

Late last month, the FDA said it would allow girls as young as 15 years old to buy Plan B One-Step contraception, made by a unit of Teva Pharmaceutical Industries Ltd, without a prescription. Cashiers will still have to verify the customer's age before selling it. The agency said the move was based on data provided by Teva that showed girls of that age could safely use the drug without the intervention of a healthcare provider.

Korman called the decision "a lot of nonsense," saying that 15- and 16-year-olds may not have photo identification needed to buy the drug.

The judge noted that the FDA's restrictions still apply to other forms of emergency contraception, including a two-pill version of Plan B and its generic equivalents. These are only available to women 17 and older with identification.

Korman also questioned the timing of the decision, made one day before the FDA filed its notice of appeal of the April order.

"I'm convinced the only reason you decided it when it was decided was to sugarcoat this appeal," Korman told a lawyer for the FDA, Farzin Franklin Amanat.

A lawyer for the plaintiffs, Janet Crepps of the Center for Reproductive Rights, countered that the different access rules for Plan B One-Step and other forms of emergency contraception had created a "convoluted" system for girls and women seeking the drug in its brand name and generic forms.

"That's what happens when you let politicians instead of scientists make these decisions," Korman replied.

Emergency contraceptives generally sell for $10 to $80. Although they can work as long as 120 hours after unprotected sex, they are most effective in the first 24 hours.

Asked about the ongoing court case, Teva Chief Executive Jeremy Levin said the company provides medicines where they are needed.

"I'm not interested in getting into politics," he told the Reuters Health Summit. "The bottom line is that we believe we are providing an important medicine."

Uncredited / AP

This undated image made available by Teva Women's Health shows the packaging for their Plan B One-Step (levonorgestrel) tablet, one of the brands known as the "morning-after pill."

U.S. regulators on Tuesday lowered the age limit for Plan B One-Step emergency contraception, approving it for sale to girls as young as 15 and agreeing it will be available without a prescription and on store shelves instead of behind pharmacy counters, Food and Drug Administration officials announced. 

The move, which grants an amended application by drugmaker Teva Women's Health Inc., is a separate action from a federal judge's ruling earlier this month that ordered the FDA to make the so-called "morning after pill" available to girls and women of all reproductive ages. It comes just days before U.S. District Court Judge Edward Korman's decision is set to take effect.

"The FDA’s approval of Teva’s current application for Plan B One-Step is independent of that litigation and this decision is not intended to address the judge’s ruling," agency officials said in a statement.

Under the FDA's latest action, the emergency contraception will now be labeled as not for sale to those younger than 15 and will require proof of age. It will not be available where age cannot be verified, but will be sold during normal retail hours outside pharmacy hours, likely in the women's health or family planning aisles. In addition, Teva has arranged to have a security tag placed on all cartons to prevent theft.

The action alters the FDA’s controversial decision in December 2011 not to make Plan B One-Step available over the counter to girls younger than 17. At that time, Health and Human Services Secretary Kathleen Sebelius overruled an FDA committee recommendation -- and Commissioner Margaret Hamburg -- to force the agency to limit access to emergency contraception to younger girls. That move was hotly disputed by medical experts who said the drug was safe and effective for girls and women and widely regarded as an effort to avoid political fallout for President Barack Obama's administration during an election year.

In granting Teva’s amended application Tuesday, Hamburg said it was based on science that shows access to emergency contraception has the potential to decrease the rate of unintended pregnancies in the U.S.

“The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly, and that it does not prevent the transmission of a sexually transmitted disease,” Hamburg said in a statement.

U.S. Department of Justice officials are still considering whether to appeal Korman's April 5 decision, which reversed the 2011 FDA ruling and orders the agency to make emergency contraception products that contain levonorgestrel available without age or so-called “point of sale” restrictions. The FDA has 30 days, or until May 5 or 6 to take action.

In a sharply worded 59-page ruling, Korman said the FDA's decisions about the drug were "politically motivated, scientifically unjustified and contrary to agency precedent."

The ruling appeared to apply to Plan B One-Step and generic brands of the morning-after pill, although Korman gave the FDA the option of limiting the expanded access just to Plan B One-Step, if the agency believed that the one-pill option was better than products that use two pills.

The Teva approval drew praise from officials at Planned Parenthood officials, who supported wider access to emergency contraception. 

"While there are still practical questions to resolve, this is an important step forward to expand access to emergency contraception and for preventing unintended pregnancy," agency President Cecile Richards said in a statement. "Emergency contraception is a safe and effective form of birth control that can prevent pregnancy if taken within five days of unprotected sex. This decision will eliminate some of the biggest barriers and hurdles that women face in getting emergency contraception when they need it, which means many more women will be able to prevent unintended pregnancy."

However, the move to approve Teva's application without addressing the judge's order was sharply criticized by the reproductive rights advocates who brought the lawsuit in 2001. 

“Lowering the age restriction to 15 for over-the-counter access to Plan B One-Step may reduce delays for some young women -- but it does nothing to address the significant barriers that far too many women of all ages will still find if they arrive at the drugstore without identification or after the pharmacy gates have been closed for the night or weekend," said Nancy Northup, president and chief executive of the Center for Reproductive Rights, which brought the lawsuit. 

“These are daunting and sometimes insurmountable hoops women are forced to jump through in time-sensitive circumstances, and we will continue our battle in court to remove these arbitrary restrictions on emergency contraception for all women," she added.

The application from Teva, based in North Wales, Pa., was pending before the judge's ruling, FDA officials said. Denise Bradley, a Teva spokeswoman, called the approval "a significant milestone for women."

Anti-abortion advocates objected to making emergency contraception more available to young girls  because they believe that the emergency contraception drugs induce abortions. 

Plan B One-Step is an emergency contraceptive aimed at reducing the possibility of pregnancy if taken within three days of unprotected intercourse. It uses a single pill that contains a high dose of the same hormone used in birth control pills to prevent or delay ovulation, prevent fertilization or, in some cases, prevent implantation of a fertilized egg in the uterine lining. Plan B One-Step will not end a pregnancy if a woman is already pregnant and there is no medical evidence it harms a developing fetus, FDA officials said.

Plan B, available from generic manufacturers, uses two doses of levonorgestrel. Another emergency contraceptive, ella, or ulipristal, is a prescription-only product that prevents pregnancy when taken within five days of unprotected intercourse. The FDA's decision Tuesday does not affect Plan B or ella. 

Emergency contraception products do not protect against sexually transmitted diseases. 

Related stories: 

• Judge: Make Plan B available to all girls without prescription

A new federal court ruling has essentially turned the controversial “morning-after pill” into an over-the-counter drug, likely making the medication far more available to teens fearing pregnancy, even in states like Washington and Illinois where pharmacists currently can refuse to sell it.

The new ruling threw out the Food and Drug Administration’s requirement that girls younger than 17 have a prescription before a pharmacist could dispense Plan B. Because of the age requirement, pharmacists ended up controlling who received the medication because IDs had to be checked before any medication could be dispensed.

The FDA has 30 days to appeal. If it fails to get the new ruling overturned, Plan B and other emergency contraception will become, essentially, an OTC medication that could share shelf space with condoms and yeast busting medications.

Up until now, pharmacists in Washington and Illinois had been assured by the courts that they could choose not to dispense Plan B if they so chose. A federal judge ruled in February of 2012 that Washington state couldn’t force pharmacies to sell Plan B. Then in September of the same year, an Illinois appellate court affirmed a lower court’s ruling that pharmacists could not be forced by the state to sell Plan B if they had religious objections.

As an OTC drug, Plan B would not need to be kept behind the counter, meaning that pharmacists would have little control over its sales.

But with the issue still up in the air because of a possible appeal, it’s hard to know how everything will shake out.

“It will be interesting to see how the case plays out,” said Garth Reynolds, executive director of the Illinois Pharmacist Association. “I’m not sure what the immediate impact will be on current dispensing.”

Until there’s a final answer, Reynolds said, “it will be up to individual pharmacists how to deal with the new ruling. If it’s upheld, pharmacies will obey the law. ”

Even without the change, pharmacies in Illinois are required by law to fill prescriptions when they are presented, said Susan Hofer Hofer, a spokesperson for the Illinois Department of Financial and Professional Regulation, which oversees pharmacies and the professionals who work in them.

“We have a law that says that an individual pharmacist may refuse to provide any medicine they choose, but the pharmacy must make an arrangement so the patient can get served at that pharmacy,” Hofer said. “We’re in court right now with pharmacists who say they don’t want to do it.”

How does that square with the law? These are pharmacies that are owned by a pharmacist who is refusing not only to fill prescriptions for Plan B himself, but also to find someone else to do the job, Hofer explained.

In Washington state, pharmacist Steve Lee says the new ruling won’t make much of a difference.

“I think people who have a need for that should be able to buy it,” he says.

None of his pharmacists have refused to sell Plan B to any woman, however, he adds that the “morning after pill” – which sells for approximately $50 -- is not a big seller at his small pharmacy in the Ballard neighborhood of Seattle.

“We have it in the store but we’ve never sold one,” he says. “We’ve had it since it became available. We always have one but they just sit here and expire.”

Jim Krell, a pharmacist in Mt. Vernon, Wash., echoes Lee’s comments regarding the limited usage of the "morning-after pill."

“When you read about this in the press, it sounds like this product is being used a lot,” he says. “In this community – and my feeling is it’s the same statewide – the demand for Plan B is not that great. On average, we might sell it once a month, maybe. And it’s being used responsibly when it is being used. We don’t see what the big deal is.”

If the new ruling stands, individual pharmacists will have very little wiggle room when it comes to Plan B and other emergency contraception, predicted Carmen Catizone, executive director of the National Association of Boards of Pharmacy. “If it becomes an over-the-counter product, there isn’t much they can do, unless the pharmacy chooses not to stock that product. The judge cannot mandate that every pharmacy carries it.”

Even if the morning-after pill does become an OTC product, women, especially younger ones may still have trouble getting their hands on it.

“When I was 18, I tried to get Plan B but it was just so expensive that I didn’t get it,” says Melissa, a 26-year-old service industry employee from Seattle. “I went to the pharmacy to see how much it was but it was over $50. I didn’t have the money. I didn’t have insurance. And I ended up getting pregnant and then getting an abortion. It was very sad, but my boyfriend had just dumped me.”

Related stories:

Judge: Make "morning-after pill" available to all girls without prescription

Bioethicist: It's high time for "morning-after pill" ruling

Parents react to "morning-after pill's" easier access

Thank goodness for the courts. A federal judge has now done what the Obama administration had failed to do — make the “morning-after pill” available without prescription to all girls of reproductive age, including those younger than 17.

The emergency contraception pill works to prevent pregnancy up to 72 hours after sexual intercourse. The Food and Drug Administration, which had begun dragging its feet during the Bush administration over approval of this proven safe medicine, had finally cleared it for over the counter sale after a decade of hemming and hawing about nothing.

But, for reasons having everything to do with politics and nothing to do with science, public health or logic, U.S. Department of Health & Human Services Secretary Kathleen Sebelius overruled FDA’s approval in December of 2011 and said it could not be sold to girls under the age of 17 without a prescription.

The court has now righted that grave wrong.

Sebelius' decision made no sense. The pill is safe and it works. It will reduce unwanted pregnancies and be of particular help to young women who are raped, abused or coerced into sex.

Critics have made two key arguments against the pill—that it is an abortion agent and that it will encourage sex.  Neither claim holds a thimble-full of science or logic.

Scientifically, emergency contraception works by prohibiting ovulation or by prohibiting the implantation of an embryo into the lining of the uterus.  If an embryo has not implanted it cannot be aborted since it never had a chance to become anything.  Emergency contraception is only an abortion in the eyes of those blind to how reproduction works.

And as for encouraging sex, there is no reason to think that girls, some of whom are already sexually active, will be joined by hordes more who will feel free to fool around because there is a pill anymore than there is to think that condoms lead to more underage sex.

The battle over the "morning-after pill" has done nothing to solve the real problem about teenage sex -- the inability of this country to talk about sex. We don’t have enough sound sexual education in our schools, too many of our religious leaders are not effective or credible in spreading wisdom about virtue, responsibility and sex and, a lot of parents fail when it comes to engaging their kids about sex if for no reason other than what they were themselves doing at 14, 15 and 16.

As the judge noted, there is no reason whatsoever to hold this pill hostage to politicians’ whims.  It is safe, it works, and it gives a woman who has no other choice, due to contraceptive failure, abuse or rape, a way to avoid an unwanted pregnancy.  It ought to be stocked in every emergency room, pharmacy, and police station.  And your politicians and clergy should try harder to figure out how to teach our children about sexuality and sexual responsibility without making fools of themselves over a pill.

Arthur Caplan, Ph.D., is the head of the Division of Medical Ethics at NYU Langone Medical Center.

Related stories:

Judge: Make 'morning-after pill' available to all girls without prescription

CHICAGO - An Illinois appellate court Friday affirmed a lower court finding that the state cannot force pharmacies and pharmacists to sell emergency contraceptives - also known as "morning after" pills - if they have religious objections.

In 2005, former Illinois Gov. Rod Blagojevich mandated that all pharmacists and pharmacies sell "Plan B," the brand name for a drug designed to prevent pregnancy following unprotected sex or a known or suspected contraceptive failure if taken within 72 hours.

Some anti-abortion advocates object to the drugs, which work by preventing the release of an egg, preventing fertilization or stopping a fertilized egg from attaching to the uterus.

College vending machine dispenses 'morning after' pill

In 2011, an Illinois judge entered an injunction against the rule, finding no evidence that the drugs had ever been denied on religious grounds, and that the law was not neutral since it was designed to target religious objectors.

The Illinois appellate court agreed that the Illinois Health Care Right of Conscience Act protects pharmacists' decision not to dispense the contraceptives due to their beliefs.

Free birth control under health law begins

"This decision is a great victory for religious freedom," said Mark Rienzi, senior counsel for the Becket Fund, quoted in a statement about the decision.

Earlier this year, a federal court in Washington struck down a similar state rule, according to the Becket Fund, a non-profit law firm.

The American Civil Liberties Union of Illinois, which had filed an amicus brief on behalf of the state, expressed dismay at the court's decision.

Long-term contraceptives, like IUDs, gaining popularity

"We are dismayed that the court expressly refused to consider the interests of women who are seeking lawful prescription medication and essentially held that the religious practice of individuals trumps women's health care," said ACLU spokesman Ed Yohnka. "We think the court could not be more wrong."

A spokesperson for Illinois Governor Pat Quinn was not immediately available for comment.

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A new study finds that pharmacies often offered inaccurate information when they thought 17-year-old girls were seeking emergency contraception such as Plan B One-Step.

 Even though it’s legal for 17-year-olds to get the so-called morning-after pill, a new study shows that pharmacy employees often dole out the wrong information, telling the teens they’re not allowed to have the drug.

An undercover survey found that many of the pharmacies that told girls they were too young to get emergency contraception offered correct information when a doctor called seeking the pill for a 17-year-old patient, according to a report in the latest issue of the journal Pediatrics.

“I was shocked that 19 percent of 17-year-olds were told they couldn’t get the medication at all,” said Dr. Tracey Wilkinson, the study’s lead author and a general pediatrics fellow at Boston Medical Center/Boston University School of Medicine.

“That’s like one in five. And I think if you told an adolescent once that she couldn’t get the medication, she probably wouldn’t call another pharmacy. It would be the end of her attempts.”

Wilkinson’s study was aimed at evaluating the real-world availability of Plan B One-Step and other emergency contraception drugs, which are available without prescription to girls and women starting at age 17. Girls younger than 17 require prescriptions to obtain the medication.

Proponents say that using emergency contraception could prevent half of all unplanned teen pregnancies. Each year in the U.S., nearly 750,000 girls ages 15 to 19 become pregnant, and about 85 percent of those are unplanned, according to the Guttmacher Institute.

For the new study, researchers posing as either a 17-year-old girl or a doctor seeking help for a 17-year-old girl called every pharmacy in each of five U.S. cities asking about the availability and accessibility of emergency contraception.

All callers asked questions from a script. The first question was whether the pharmacy had the medication in stock -- 80 percent of the 943 pharmacies said they did. Next, the researcher posing as a teen asked if she could get the drug, while the researcher posing as the doctor of a 17-year-old patient asked if the patient could get the medication.

There was a huge disparity between the answers given to the teens and those offered to the physicians, with 19 percent of the 17-year-olds being told that they couldn’t get it under any circumstances, compared with only 3 percent of the physicians.

The next question was asked only by teen callers who had been told a 17-year-old could get the morning-after pill: “My friends said there is an age rule [regarding access without a prescription] -- do you know what it is?”

Pharmacy employees answered that incorrectly 43 percent of the time.

The researchers can’t say anything for sure about the motivation behind the misinformation because that wasn’t part of the experiment. It might be partly explained by the fact that the doctors in the study tended to get actual pharmacists on the phone while “teens” often got lower-level pharmacy employees who might have been less informed about the FDA rules. The researchers found that, in general, teens were put on hold more often and that they spoke less often to pharmacists.

It’s also possible that the misinformation was given on purpose by pharmacy employees who didn’t want to dole out morning-after pills to 17-year-olds.

“It’s a controversial topic," Wilkinson said. “It shouldn’t be, but it is. And anything with controversy heightens a person’s personal beliefs.”

Indeed, the topic has been so controversial that it forced a showdown in December over whether to make the drug available without prescription to girls younger than 17. Health and Human Services Secretary Kathleen Sebelius invoked her authority to overrule the recommendation of a Food and Drug Administration center and the agency's head, Commissioner Margaret Hamburg, who supported the move.

Wilkinson hopes the new study will raise awareness about the problem of pharmacists dispensing inaccurate information.

“This was disappointing,” she said. “I hope this study will instigate some sort of change on all fronts, for teenagers, pharmacists, staff and also clinicians.”       

Related stories:

Plan B won't be available OTC to younger teens, HHS says

Bioethicist: Plan B ruling trumps good science with bad policy

The morning-after pill known as Plan B is steeped in controversy again. The Department of Health and Human Services has taken the rare step of overruling the Food and Drug Administration and its science advisors and will not allow the pill to be sold over the counter in drugstores unless a woman can prove she is older than 17. 

The stunning override of the FDA is bad public policy.  This is a case of politics triumphing over science yet again when it comes to matters of reproduction, contraception and abortion in the U.S.

Plan B has stirred strong emotions from the minute its manufacturer sought FDA approval. During the Bush administration, abortion foes tried to stifle the drug on the grounds that it works as an abortion agent even though the drug actually prevents a fertilized egg from implanting in the womb, which is not in the scientific sense of the term an abortion. Some docs and pharmacists made headlines by saying they would not prescribe the pill even in the case of a rape.  Some hospitals will not stock it.

Plan B won't be available OTC for younger teens

But the pill has been shown safe time and time again. The FDA panel that approved it for over-the-counter use simply could not find any scientific reason to worry about its safety. The benefits of preventing unwanted pregnancies and the risks of surgical abortions are significant.

So why not let any woman, even a girl of 14 or 15, have access?  Because, politically at least, saying a young girl can protect herself against an unwanted pregnancy is not the most popular stance to take.

The fact is that many teen girls have sex – and many will not talk about it with their parents.

Sometimes that sex is coerced or forced. Sometimes it is a relative or friend who is the exploiter.

These are not scenarios that we like to admit to. But they are real. That's why the pills should be readily available on drugstore shelves, but include an insert listing resources where young girls can get help.

Making Plan B hard to get doesn't protect these young girls. It puts them in an even worse spot.

Read more columns by Art Caplan:

Shame on school for rejecting boy with HIV

Vatican push for adult stem cells can't ignore good science

Art Caplan, Ph.D., is the director for the Center for Bioethics at the University of Pennsylvania.  Follow him on Twitter @ArthurCaplan.