Written by Bridgette Dunlap for RH Reality Check. This diary is cross-posted; commenters wishing to engage directly with the author should do so at the original post.

Government lawyers filed an emergency motion to dismiss lawsuit over contraceptive coverage mandate citing exorbitant costs in responding to document requests.

This week, the government filed an emergency motion in the New York Archdiocese’s lawsuit against the contraceptive coverage mandate, requesting that the court halt proceedings and dismiss the case. The emergency is that the government is hemorrhaging money defending a regulation it will never enforce against the Archdiocese.

Roman Catholic Archdiocese of NY v. Sebelius is the only lawsuit out of the 23 brought by religiously affiliated organizations not to be dismissed at the district court level for lack of standing or ripeness. The cases have been dismissed because religiously affiliated non-profits are currently completely exempt from the contraceptive coverage requirement. They enjoy a one-year safe harbor period provided for the religious accommodation to be finalized. If you haven’t been injured, you can’t sue.

The government swore up and down from the day the case was filed that the rule in its current form would never be enforced against the Archdiocese and its co-plaintiffs and that a new rule with a new religious accommodation was on the way. As promised, the Obama administration released a new proposed rule, is now reviewing comments from the public on it, and will release the final rule by August. However, in the New York Archdiocese case, Judge Brian M. Cogan found that the administration’s assurances were not enough and that the impending threat of the rule was injury enough for the plaintiffs to proceed.

The Archdiocese et al. proceeded to serve the government with requests for every document under the sun. “Discovery” is the process in which litigating parties get evidence by requesting relevant documents from each other. To respond to a document request, a party has to review documents to determine whether they are responsive to the request and make a log of documents that are responsive but won’t be turned over because they are protected by attorney-client or another privilege. Computer searches only get you so far; a human attorney or paralegal has to determine if a document is responsive or privileged.

Plaintiffs in these cases being 1 for 23, the Archdiocese may have sought to make the most of its unique situation. It made discovery requests the government calls “enormously burdensome and irrelevant.” The Archdiocese also noticed a deposition of Health and Human Services (HHS) Secretary Kathleen Sebelius. Lawsuits are brought over regulations all the time — it is pretty audacious to demand a cabinet member show up in person for yours. That was indeed too far, and Judge Cogan granted Sebelius a protective order.

The plaintiffs didn’t stop there. The Archdiocese subpoenaed the Executive Office of the President (EOP), even though it isn’t a party to the lawsuit, many of the requested documents are protected by various privileges, and you must have an extra good reason to get documents from the president. Also, the EOP being in D.C., the subpoena was issued in a district that has thrown out three of these 23 lawsuits for lack of jurisdiction.

The Archdiocese later withdrew the subpoena. We don’t know why. Perhaps it realized it was an unreasonable request. This did not happen, alas, until after our tax dollars were put to work on a very lengthy motion to quash the subpoena. But whatever that cost, it pales in comparison to the expenditures of various agencies on the New York document requests; in the emergency motion, the government estimates completing the requested document production would take eight years and cost over $10 million.

We should take that estimate with a grain of salt, of course, but the government has sought to back it up. Attached to the emergency motion are declarations from officials of various offices and agencies as to what they have spent so far on this one case and what they estimate it will cost to finish. Two-hundred HHS employees have spent have spent over 2,000 hours and located over 7.6 million pages of potentially responsive documents so far. That has cost over $177,000. Those documents haven’t been reviewed by HHS or their Department of Justice counsel yet. The Internal Revenue Service has spent over a quarter of a million dollars.

The lawyers, paralegals, and IT professionals needed to complete discovery are expensive — even those of the lower-paid government variety. Offices that don’t have enough staff for this have hired contract lawyers, but they can’t afford to do that anymore because of the sequester. Lest you think it’s not a big deal to have government lawyers tied up or that the effect is minimal in the scope of things, consider one example contained in the declaration from the Department of Labor (DOL). The DOL’s Plan Benefits Security Division investigates and litigates cases of fraud or mismanagement in employee benefits. The division, which recovered $1.38 billion for U.S. workers in 2011, argues that the impact on the public interest of putting its attorneys on document review will be far greater than the financial loss.

The Archdiocese, which employs 10,000 people in programs receiving many millions of dollars in government grants each year, will never have to provide health plans with contraceptive coverage under the rule as proposed. Despite this, it is waging a legal battle that is imposing significant costs on the taxpayers who fund its work. And this is only one lawsuit. With the additional cases brought by secular for-profit corporations, over 60 lawsuits have been filed in this scorched earth litigation campaign — which we have to pay to defend.

On the same day the emergency motion was filed, Judge Cogan granted it in part, staying all discovery and proceedings until the contraceptive coverage rule is final. So the government lawyers can get back to other business for the moment. But once the rule is final, I expect we will see that some if not all of those 22 dismissed cases (the ones that haven’t already been appealed) will be refiled.

Back in February, with the sequester looming, the U.S. Conference of Catholic Bishops, which, like the Archdiocese of New York, is led by Cardinal Timothy Dolan, signed a statement by religious leaders urging legislators to protect the interests of the poor. The Bishops’ litigiousness does not reflect the same awareness of our limited resources nor concern for those who will be hurt most by the sequester. Instead, the Archdiocese seeks to deprive its employees of affordable contraception — provided by an outside company — that will enable employees to limit their families to the size they want and can support, using up resources that are needed elsewhere in a time of economic distress.

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Written by Dr. Linda Prine and Dr. Ruth Lesnewski for RH Reality Check. This diary is cross-posted; commenters wishing to engage directly with the author should do so at the original post.

In one of the clinics where we work, a 16-year-old girl came in with a sprained ankle.  She left with a prescription for birth control.

This turn of events is not as surprising as it seems:  As family physicians, we treat the whole person.  A quick update revealed that our 16-year-old patient had recently begun to have unprotected sex — and had no plan to get birth control. One of the reasons we love practicing family medicine is that we get to know our patients over time and provide the preventive care they need at every possible opportunity.

That is why we are dismayed that the Accreditation Council of Graduate Medical Education (ACGME) has proposed changes to the guidelines for family medicine residency programs removing the requirement that residents learn to provide contraception. These changes will go into effect in 2014 unless the ACGME is convinced otherwise, during an open comment period taking place this week.

A majority of U.S. women get their basic health care from a family physician or other primary care provider, and often that includes reproductive health care. Especially in rural and low-income areas, family physicians do it all! They not only provide birth control but also provide prenatal care, deliver babies, manage miscarriages, counsel patients about unintended pregnancies, and, increasingly, offer pregnancy termination so that their patients do not have to travel long distances and see unfamiliar doctors for these services.

ACGME’s motivations are legitimate:  It seeks to simplify the rules for the nation’s family medicine residency programs — numbering over 450 — and to allow for more creativity and flexibility. In some areas of practice, this makes sense. Many programs will continue to teach contraception; it will depend on the culture of the institution. However, residency programs based in religiously-affiliated hospitals (which operate nearly 20 percent of inpatient community-hospital beds in the U.S.), will most likely drop birth control training immediately.

Because the ACGME currently requires birth control training, religiously-affiliated institutions must figure out a way to comply. Many rotate their residents through external clinics to learn these skills — which are essential since 99 percent of women in the United States who have ever had sexual intercourse have used a method of contraception other than natural family planning at some point in their lives. Without this requirement, residents in religiously-affiliated programs may get no training at all in contraception.

Just last week, we attended a meeting where an assistant residency director expressed satisfaction at the prospect of no longer needing to teach residents how to counsel patients with unintended pregnancies of all of their options. This is our concern: Limiting the training of family medicine residents in birth control will have a disproportionate impact on the millions of low-income and rural women and teens who rely on their family doctors to provide the full-spectrum of reproductive health care. The Affordable Care Act greatly expands access to contraception for millions of women in the United States. But, if clinicians aren’t trained in providing contraception, then that access is meaningless, even if it is covered. We need to make sure all clinicians who provide primary health care for women are trained to provide high-quality contraceptive care.

Our next generation of family physicians must learn and practice more contraception, not less. Otherwise our shamefully high rate of unintended pregnancy (the highest in the developed world) will rise further.

There is time to make a difference. The ACGME is accepting comments on the proposed guidelines until April 25, 2013. Click here to download our suggested version of the official comment form.  Fill in your information and email it to familymedicine@acgme.org.  The Reproductive Health Access Project has an online campaign for all of us to tell the ACGME that their changes affect our health care.

Written by Kathy Bougher for RH Reality Check. This diary is cross-posted; commenters wishing to engage directly with the author should do so at the original post.

The women of El Salvador are denied life-saving access to abortion.

Beatriz wants to live. A 22-year-old Salvadoran from a poor, rural community, Beatriz (a pseudonym to protect privacy) suffers from chronic and severe medical conditions. She is the mother of an infant. And she is roughly 18 weeks pregnant with an anencephalic fetus, a fetus without a brain. Doctors at the Maternity Hospital determined that the pregnancy is life-threatening, and Beatriz requested that Salvadoran medical personnel perform an abortion, but a 1998 law in El Salvador prohibits all abortions, without exception.

The Salvadoran feminist organization Agrupación Ciudadana por la Despenalización del Aborto Terapéutico, Ético y Eugénesico (Citizen Group for the Decriminalization of Therapeutic, Ethical and Eugenic Abortion), which has been working to decriminalize abortion in the country since 2009, petitioned the Salvadoran Supreme Court on April 15 to intervene and to direct medical personnel to provide without fear of criminal prosecution the procedures Beatriz needs to save her life. Under current law, both Beatriz and any medical personnel involved in an abortion would face criminal charges and prison time. The court responded with a temporary directive that medical personnel provide the care necessary to guarantee her life and health while they make a decision regarding the petition for an abortion. Medical personnel were also directed to present to the court within five days a report on the condition of the mother and the fetus to inform their deliberations.

Within the past few days Amnesty International has initiated a petition asking for life-saving medical care, including an abortion; the United Nations has spoken; and the Salvadoran Minister of Health, Dr. Maria Isabel Rodriguez, has requested that the Supreme Court approve the request. Dr. Rodriguez emphasized that Beatriz’s kidney function continues to deteriorate as the pregnancy advances, and that the public health system is ready to perform an abortion. The Salvadoran Attorney General for Human Rights also supports the request.

At a press conference the Agrupación convened in San Salvador on April 18, Esther Major, an Amnesty International representative in El Salvador, characterized the way Beatriz is being treated as “nothing less than cruel and inhuman.”

“While we are talking, while the Court is thinking and the government is delaying, Beatriz is suffering. … The Salvadoran government has clear obligations, international as well as domestic, to protect Beatriz’s life, and to assure that Beatriz can access vital treatment as soon as possible.”

Legal reforms in 1998 in El Salvador, promulgated by conservative religious forces, outlawed  abortion without exception. Previously it was permitted if the pregnancy resulted from rape or incest, the mother’s life was in danger, or the fetus was not viable. In addition, a constitutional amendment was added declaring that life begins at conception, which means that prosecutors can charge women who seek abortions with aggravated homicide, punishable by 30 to 50 years in prison, rather than the lesser crime of abortion, which carries a term of two to eight years.

Threats of prosecution and prison terms are not to be taken lightly under the 1998 law. The Agrupación has mounted legal and educational campaigns to secure the release of six women from prison. Since no comprehensive data exist in the country, the Agrupación is conducting its own research, which reveals that currently at least 24 women are serving prison terms of up to 40 years for abortion or aggravated homicide related to abortion charges.

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Written by Jessica Mason Pieklo for RH Reality Check. This diary is cross-posted; commenters wishing to engage directly with the author should do so at the original post.

A court ruled communications with Tiller's killer to be covered by ministerial protections.

On Friday U.S. District Judge J. Thomas Marten handed anti-choice terrorist Angel Dillard a win, ruling Dillard doesn’t have to disclose “ministerial discussions” she had with Scott Roeder, the man convicted of murdering abortion provider Dr. George Tiller.

As reported in the Topeka Capital-Journal, Marten’s ruling reversed an earlier decision that Dillard’s communications with Roeder were not protected by the ministerial exception because Dillard is not an ordained minister. But Marten held that Dillard was acting as a lay minister and was therefore entitled to the protection. It’s an incredible expansion of the privilege and one which the radical anti-choice community is no doubt taking notice.

Dillard is accused of sending a threatening letter to Dr. Mila Means who was training to provide abortion services after Tiller’s murder. According to the Department of Justice complaint against Dillard, the letter to Means mentioned Tiller’s assassination and warned Means against providing abortion services in Wichita.

In the same ruling Marten said Dillard must disclose communications she had with another inmate, Robert Campbell. Campbell claims Dillard hired him to stalk Means, while Dillard denies this and claims Campbell is trying to blackmail her.

But just because those communications must be disclosed does not guarantee they will make it into evidence in the trial, currently slated for October. At the time of trial they can be excluded from evidence if a judge decides the statements are too unreliable, a fact judge Marten made clear in his ruling. At issue in the case is whether the letter Dillard wrote to Means was a “true threat” in violation of the federal law designed to protect access to abortion clinics. In the letter, Dillard allegedly wrote that thousands of people from across the nation were scrutinizing Means’ background and would know “your habits and routines.”

The letter is chilling. In it Dillard writes, “They know where you shop, who your friends are, what you drive, where you live,” the letter said. “You will be checking under your car every day — because maybe today is the day someone places an explosive under it.”

The Dillard trial has shed light on the violent underworld of radical anti-abortion activists and the last thing this community needs is any additional enabling by the federal courts. But that’s exactly what this ruling does. If someone like Dillard can claim to be a minister so as to shield communications with convicted assassins like Scott Roeder who have admitted to wanting to instigate more deadly violence against clinic workers, then we can expect to see a lot more ministers among the most violent actors in the anti-abortion movement.

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Written by Martha Kempner for RH Reality Check. This diary is cross-posted; commenters wishing to engage directly with the author should do so at the original post.

Ohio wants to define "gateway sexual behavior" and then ban teachers from educating about it.

Though most of us are still not quite sure what it is, the concept of “gateway sexual activity” is back, or at least a ban on teaching about it is back.This time it is Republicans on the Ohio House Finance Committee who are worried about our young people heading down the wrong sexual path. So worried, in fact, that they are willing to impose fines on anyone who teaches about such sexual activity. That’s right, an amendment to the budget passed by the committee yesterday would prohibit providing or distributing condoms or other contraceptives on school grounds and ban any instruction that promotes “gateway sexual activity.” Teachers or organizations that violate this ban could be subject to lawsuits by parents as well as a $5,000 fine.

Some of us remember the first time we heard this phrase; it was last year when Tennessee Republicans passed a similar law that became the butt of national jokes because no one knew what a “gateway” behavior would be — a kiss, a foot rub, an expensive dinner? The law didn’t define it but lawmakers in Tennessee promised that we would know it when we saw it. As I reported for RH Reality Check at the time, one legislator explained in testimony on the floor:

“Everybody in this room knows what gateway sexual activity is. Everybody knows there are certain buttons when you push them, certain switches when you turn them on, there’s no stopping, especially for undisciplined, untrained, untaught, and unraised children who just want to feel affection from somebody or anybody.”

I can’t say that this explanation helped enlighten me though it did infuriate me with all of its judgment and blame.  Like many others, I preferred comedian Steven Colbert’s snarky take on it:

“Kissing and hugging are just the last stop before the train pulls into Groin Central Station. We desperately need to intervene earlier to keep kids from engaging in… all the things that lead to the things that lead to sex.”

In an effort to avoid any similar confusion (and perhaps prevent being made fun of on Comedy Central), Ohio legislators provided a definition of “gateway sexual activity.”  And, because teenage sexual behavior is so bad as to be felonious, they took the language straight from the state’s criminal code. So schools cannot promote:

“…any touching of an erogenous zone of another, including without limitation the thigh, genitals, buttock, pubic region, or, if the person is a female, a breast, for the purpose of sexually arousing or gratifying either person.”

Despite this very clear definition of behaviors that Ohio lawmakers think will inevitably lead to teens boffing like bunnies, I imagine that teachers in the state are still confused as to what they can and can’t say. After all, sexuality education is not about promoting specific behaviors, it is (among many, many other things) about helping young people think critically about those behaviors they will and will not choose for themselves. I suppose, though, that such confusion, combined with a hefty fine, will have the exact effect that lawmakers want; teachers will play it safe and say nothing.

As Damon Asbury, a lobbyist for the Ohio School Boards Association told the Dayton Daily News:

“I don’t think we should have teachers put on trial for teaching a prescribed curriculum. It takes you back to the Scopes Trial.”

Kellie Copeland of NARAL Pro-Choice Ohio told the Dayton Daily News that she also opposed the ban noting the amendment appears to be an attempt to ban comprehensive sex education programs in schools. She added:

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Written by Jodi Jacobson for RH Reality Check. This diary is cross-posted; commenters wishing to engage directly with the author should do so at the original post.

In a long-awaited decision released early this morning, U.S. District Court Judge Edward Korman ordered the U.S. Food and Drug Administration (FDA) to make emergency contraception available over-the-counter to women of all ages, marking a major win for public health and women’s rights in a year that has seen science otherwise buried under an avalanche of anti-choice politics. In his decision, Judge Korman orders the FDA to make levonorgestrel-based emergency contraception available over-the-counter without an age or point-of-sale restriction.

Today’s order was issued in response to the Center for Reproductive Rights’ (CRR) renewed lawsuit against the agency seeking to expand over-the-counter access to all brands of the morning-after pill, including Plan B One-Step and Next Choice, to women of all ages.

The court has ordered the FDA to make emergency contraception available without a prescription and without point-of-sale or age restrictions within 30 days, with the option to limit the change to only Plan B One-Step if the agency “actually believes there is any significant difference between the one- and two-pill products” and to require new labeling if necessary.

Women’s rights groups are celebrating the decision.

“Today science has finally prevailed over politics,” said Nancy Northup, president and CEO of CRR, which brought this and other lawsuits. “This landmark court decision has struck a huge blow to the deep-seated discrimination that has for too long denied women access to a full range of safe and effective birth control methods. “Women all over the country will no longer face arbitrary delays and barriers just to get emergency contraception. It’s a true victory for all women, especially young women, women without government-issued identification, and those who live in areas with limited pharmacy hours,” she added.

Susannah Baruch, interim president and CEO of the Reproductive Health Technologies Project, which has been a leading advocate for emergency contraception, concurred: “Today we celebrate a long overdue victory for all women. Our decade long struggle is finally over. Emergency contraception will now sit on store shelves allowing timely access to this important product used to prevent unintended pregnancy. We urge Secretary Sebelius and the FDA to move swiftly to put emergency contraception on store shelves and into the hands of women and couples who need it.”

In a statement, the National Latina Institute for Reproductive Health applauded the ruling:

For Latinas in particular, expanded access to emergency contraception is critical for making the best decisions for our families and ourselves. For too long, this important backup birth control method has been kept behind the counter and out of reach. Immigrant women and new Americans of all ages have been hit particularly hard, since they are less likely to have government identification. This decision removes one barrier for Latinas who need contraception — though others, like poverty, discrimination, language and immigration status, remain.

This victory came after a long and unnecessarily difficult battle that was marred by politics, irrespective of the political party in charge. (See timeline following article.)

The FDA first approved emergency contraception (EC) for prescription use in 1999. Subsequently, study after study showed the safety of EC for women of all ages seeking to prevent an unplanned pregnancy after unprotected sex or contraceptive failure. In 2003, the first application was made to the FDA to approve EC for over-the-counter (OTC) sales. And thus began a long game of politics that has spanned both the Bush and Obama administrations. First, the Bush administration refused to act to make EC available OTC, resulting in the first successful lawsuit by advocates to ensure that science, rather than politics, governed women’s access to this method of basic preventive reproductive health care. EC was first made available OTC for women ages 18 and older, though the science clearly affirmed its safety for younger women.

After years of advocacy and further scientific proof of efficacy and safety, it seemed that finally EC would be made available over the counter for all women. However, in a deeply controversial move in December 2011, Kathleen Sebelius, secretary of the Department of Health and Human Services (HHS), overruled the decision by FDA Commissioner Margaret Hamburg to approve over-the-counter sales of Plan B One-Step. President Obama publicly supported Sebelius’ decision, in what was widely seen as a political move. Public health, medical, and legal groups went into overdrive, conducting a wide-ranging public education campaign, launching a citizen’s petition, releasing statements in support of EC OTC, and filing the lawsuit that led to today’s decision, in which Judge Korman called Sebelius’s actions “politically motivated, scientifically unjustified, and contrary to agency precedent.” Said Judge Korman, “The decisions of the Secretary with respect to Plan B One-Step and that of the FDA with respect to the Citizen Petition, which it had no choice but to deny, were arbitrary, capricious, and unreasonable.”

“It’s shameful it has taken over a decade and a federal court order for the U.S. government to implement in policy what studies and experience have proven time and time again — emergency contraception is safe and effective and should be available for women of all ages,” said Janet Crepps, senior counsel for CRR.

Currently, EC is available to women ages 17 and older without a prescription; young women under 17 are required to obtain a prescription from a physician. Even for women 17 and older, however, the medication is available only at health clinics or pharmacies, upon request and with adequate identification.

This unique and unnecessary dual scheme, notes CRR, has impeded access even for women who are allowed to obtain the drug without a prescription, as evidenced by several studies, including one published in the journal Pediatrics earlier this year. A total of 943 pharmacies in five major cities were contacted twice by researchers at Boston University — once the researchers posed as a 17-year-olds and another time as physicians. The study found that there misinformation was common regarding who can take EC and at what age it is available without a prescription, creating barriers to timely access. According to the research, nearly 20 percent of the drugstores contacted denied the “17-year-olds” access to the pill.

With the court’s ruling today, drug companies can now apply to make EC available to women of all ages and at stores other than just pharmacies — eliminating human error in determining who can and cannot purchase the medication.

#####

CRR Emergency Contraception Case Timeline

July 28, 1999: The U.S. Food and Drug Administration (FDA) approves Plan B, an emergency contraceptive medication, for prescription use.

February 14, 2001: The Center for Reproductive Rights files a Citizen Petition with the FDA on behalf of over 70 medical and public health organizations to make Plan B available without a prescription or over-the-counter (OTC).

April 21, 2003: Women’s Capital Corporation, the manufacturer of Plan B, files an application with the FDA to make Plan B available OTC.

Late December 2003/January 2004: After a panel of FDA experts recommends approval of the Plan B application, Dr. Steven Galson, the head of the office responsible for making the final decision, informs his staff that the regular procedures won’t be followed this time, and that that office won’t make the final decision. (Jenkins deposition)

December 2003 to Jan 17, 2004: Galson confesses to a co-worker that he has to reject the Plan B application because he’s afraid he’ll lose his job. (Jenkins deposition) Dr. Janet Woodcock, the second in command at the FDA, tells a colleague that the agency first has to reject the application, then approve the drug later with an age restriction in order to “appease the administration’s constituents.” (Houn deposition)

May 6, 2004: The FDA denies the manufacturer application and suggests Barr, the drug’s new manufacturer, amend the application to request an OTC switch only for women 16 and older. (Barr revises the application; the FDA schedules a decision for January.)

January 21, 2005: After the FDA fails to meet its deadline, the Center files a lawsuit against the agency for ignoring science and holding Plan B to a different standard than other drugs.

August 26, 2005: The FDA misses its second deadline to rule on Barr’s application. In a peculiar move, the agency requests the public provide input over an indefinite period of time on how to dispense the drug.

February 24, 2006: The Center is cleared to depose high-level FDA officials. The New York magistrate judge cites strong showing of “bad faith and improper behavior” by the FDA.

June 9, 2006: FDA denies Citizen Petition for the first time.

August 24, 2006: The FDA agrees to make Plan B available without a prescription, but only to women 18 and older who can provide government issued identification. The FDA also requires that Plan B be sold behind pharmacy counters.

March 30, 2007: Center files for summary judgment in the case, arguing that the undisputed facts found in evidence gathered through discovery make it unnecessary for the court to hold a trial, and that the court should order the FDA to make Plan B available without a prescription to women of all ages.

March 23, 2009: Court orders the FDA to approve Plan B for those 17 and older without a prescription and to reconsider the Citizen Petition and all age and other restrictions on OTC access.

July 10, 2009: The FDA approves Plan B OTC for those 17 and older. The FDA also approves Plan B One-Step, which is a product that consists of the same drug as Plan B but in one pill rather than two. Both Plan B and Plan B One Step are OTC for those 17 and older and prescription-only for those 16 and younger.

August 28, 2009: The FDA approves Next Choice, a generic version of Plan B, under the same regime: OTC for those 17 and older and prescription-only for those 16 and younger.

November 16, 2010: The Center files a motion for contempt of court against the FDA for failing to reconsider the Citizen Petition and the current restrictions on OTC access to Plan B.

December 1, 2010: After receiving FDA approval for prescription-only use, Watson Pharmaceuticals launches ella, another form of emergency contraception (ulipristal acetate).

February 7, 2011: Teva Pharmaceuticals, the manufacturer of Plan B One-Step, files a supplemental new drug application (sNDA) with the FDA so that the drug will be available OTC for women of all ages.

Dec. 7, 2011: HHS Secretary Sebelius takes an unprecedented step to block FDA Commissioner Hamburg’s approval of Plan B One-Step manufacturer’s application for OTC status, which included additional data that confirmed its safety for all-ages use. The next day, President Obama publicly supports Sebelius’s decision, “as a father of two daughters.”

Dec. 12, 2011: On the eve of a court hearing on the Center’s motion for contempt, the FDA denies the Citizen Petition for a second time based on a lack of teen-specific data for the two-dose medication, despite the volume of data before the FDA on two-pill emergency contraception products, which data for one pill products of emergency contraception confirmed.

Dec. 13, 2011: Judge denies contempt motion because FDA had ruled on the Citizen Petition the night before, but invites CRR to reopen the case. Judge notes striking similarities between recent actions and 2005-2009.

Feb. 8, 2012: CRR reopens its case, filing a motion for preliminary injunction and summary judgment for immediate relief that would allow OTC access for all levonorgestrel-based emergency contraceptives (both one and two pill versions) without any age or point of sale restrictions. CRR also adds Sebelius as a defendant and supplements the complaint.

February 16, 2012: Judge Korman issues Order to Show Cause to Defendants “why the FDA should not be directed to make Plan B available to those persons whom the studies submitted to the FDA demonstrate are capable of understanding when the use of Plan B is appropriate and the instructions for its due.”

March 9, 2012: Teva Women’s Health, Inc., the manufacturer of Plan B One-Step, files a motion to intervene in the case.

April 27, 2012: Hearing held on Court Order to Show Cause and Motion of Teva Women’s Health to Intervene.

April 5, 2013: Judge Korman orders FDA to make levonorgestrel-based emergency contraception available over the counter without age or point of sale restriction.

Written by Heather Sayette for RH Reality Check. This diary is cross-posted; commenters wishing to engage directly with the author should do so at the original post.

Progressive Ecuadorian President Rafael Correa wants to ease strict anti-abortion laws.

Rafael Correa, the popular and newly re-elected leftist president of Ecuador is driving a “citizens’ revolution” committed to progressive principles and economic growth. This week he voiced unconditional support for contraception, including emergency contraception. This unprecedented support for access to sexual and reproductive health care is particularly welcome, as women’s rights advocates were beginning to wonder what the president’s revolution would mean for them.

On paper, the most recent revision to Ecuador’s constitution included unprecedented guarantees of gender equality in education, health care, property rights, equal rights in the workplace, protections for female senior citizens, priority services for pregnant women, remuneration for homemakers, and explicit reproductive freedoms such as the right to decide when and how many children to bear.

Despite these recent advances and increases in social services spending, widespread disparities and inequalities in access to health care remain, and access to safe or legal abortion services is nonexistent.

Rates of adolescent pregnancy have skyrocketed in recent years — Ecuador has the highest rate in the Andean region — and poor, rural, and indigenous young women are the most likely to become pregnant before becoming adults.  Seventeen percent of teens between the ages of 15 and 19 are already moms, many because of sexual abuse. Complicating the issue even further, Ecuador’s current criminal code only allows abortion for victims of rape who are mentally disabled, significantly excluding millions of women in a country where one in four women has been the victim of sexual violence.

Despite significant advocacy by women all over Ecuador, a wealth of evidence illustrating the benefits of decriminalization, and a worldwide trend towards liberalizing abortion laws, the government of Ecuador has not responded with a commonsense policy.

In response, a coalition of indigenous women’s, women’s, and LGBTI rights groups have joined forces to call international attention to their plight. The coalition recently submitted an alternative report on the state of the sexual and reproductive rights in Ecuador to the United Nations Committee on Economic, Social and Cultural Rights (CESCR).

The committee clearly paid attention to this input. It recommended that Ecuador amend its laws by allowing all women to access abortion services when pregnancy is a result of rape, and by introducing legislation and best practices that safeguard sexual and reproductive health and rights. The committee also recommended that Ecuador improve access to contraceptives, including emergency contraception.

These recommendations follow a global trend of activists resorting to international mechanisms when governments fail to respect human rights and to implement the international human rights agreements that they have ratified. Other international court rulings and committee recommendations have called out governments for failing to expand abortion allowances and failing to guarantee access to legal procedures. Most recently, the United Nations special rapporteur on torture called on states to eliminate bureaucracy in women’s health care, specifically to ensure that abortion and post-abortion care services are available without adverse consequences to women or health professionals. A previous report authored by the United Nations special rapporteur for the right to health went a step further to establish that laws criminalizing abortion violate the right to health and should be eliminated.

These unprecedented reports and support from international human rights bodies are important, but effective activism requires a diverse toolbox. We in the reproductive rights movement must continue to keep up the pressure in international forums. But we cannot over-rely on these mechanisms as a panacea to unresponsive policymakers. This work must be coupled with sustained domestic pressure on governments. Ecuadoran women’s rights activists, those of us in the international sexual and reproductive health and rights movement, our allies in the government, funders, and others must organize, mobilize, and collaborate.

While the Ecuadoran government has made dramatic increases in health-care spending, large-scale improvements to eliminate health disparities and unequal access to services are still needed — and the restrictive abortion law has got to go.

The United Nations committee recommendations to the Ecuadoran government are an important step forward for champions of women’s health and rights. Both globally and within Ecuador, we must keep up the fight and make it unacceptable for this or any government to continue to ignore the rights of women.

After winning the recent election with an unprecedented 58 percent of the vote, Correa openly stated that he is done making changes and will do nothing new, particularly regarding access to safe and legal abortion. But new is exactly what poor and indigenous women and young people need.

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Written by Jessica Mason Pieklo for RH Reality Check. This diary is cross-posted; commenters wishing to engage directly with the author should do so at the original post.

Anti-abortion activists and the NRA teamed up to defeat Caitlin Halligan's court nomination.

There’s hardly a better snapshot of the modern-day conservative movement than the fight over the appointment of Caitlin Halligan. And it’s ugly. Anti-choicers joined with anti-gun reform advocates to defeat the nomination of Halligan just last week by threatening a filibuster.

President Obama originally nominated Halligan, general counsel for the Manhattan district attorney’s office and former solicitor general of New York, for a seat on the D.C. Circuit Court of Appeals. Halligan was supposed to fill the seat vacated by Chief Justice John Roberts’ Supreme Court appointment to the Supreme Court. Instead, the NRA and the anti-choice lobbies joined forces to block her.

Halligan is considered by all reasonable people to be a mainstream judicial candidate who even with the dysfunction in the Senate should have been approved. Born in Ohio, Halligan graduated with honors from Princeton, and then went on to earn a J.D. from Georgetown Law School. After graduation she landed two prestigious judicial clerkships. First for the United States Court of Appeals for the District of Columbia Circuit Judge Patricia Wald and then for Supreme Court Justice Stephen Bryer. She enjoyed broad support among members of both parties and in the legal community. Still, her nomination failed.

President Obama first nominated Halligan on September 29, 2010, but the Senate refused to take up her nomination that year. Halligan was then re-nominated in January of 2011. The following month the Senate Judiciary Committee held a hearing on the nomination and voted 10 to 8 to let the nomination advance. In December of the same year, shortly before the end of the Congressional session, Senate Republicans filibustered the nomination.

The fight was not over yet. Halligan was renominated in June of 2012 but two more attempts to gain cloture on her nomination failed, this despite the fact that a majority of Senators supported the nomination. Senate Republicans successfully blocked Halligan’s nomination again, and again President Obama renominated her. In the beginning of March, 2013 Senate Majority Leader Harry Reid again filed a motion to invoke cloture and again Republicans blocked the nomination. On March 22, 2013 Halligan requested President Obama withdraw her nomination to the court.

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Written by Eleanor J. Bader for RH Reality Check. This diary is cross-posted; commenters wishing to engage directly with the author should do so at the original post.

Plan B emergency contraception is available 24 hours a day via public vending machine at one college, much to consternation of anti-choice advocates.

A little more than a year ago, during the same week that the Susan G. Komen Foundation  announced that it would no longer provide funds to Planned Parenthood, Shippensburg University, a previously little-known state college in Pennsylvania’s Cumberland Valley, captured media attention throughout the United States. The sudden spotlight on Shippensburg came as a result of a decision administrators had made five semesters earlier — at the end of the fall 2009 term — to sell Plan B Emergency Contraception (EC) from a vending machine located in a remote corner of the campus.

According to Dr. Peter M. Gigliotti, Executive Director for University Communications and Marketing at Shippensburg, roughly 300 students a year had swiped their college IDs to obtain access to the machine in the two-and-a-half years it had been operating. Each was given an opportunity to confer with a counselor in person or by phone before inserting $25 to obtain Levonorgestrel, AKA Plan B, a medication that prevents fertilization, preventing pregnancy if taken with 72 hours of unprotected intercourse.

Gigliotti believes that someone on campus — he does not know if it was a disgruntled student, faculty member, or staff person — tipped off the press that Shippensburg had a Plan B vending machine and within hours the story was garnering headlines and energizing anti-choice and abstinence-only advocates across the country. “What we did by making Plan B available in a vending machine is very emotional for a lot of people,” he begins. “When the story broke we immediately received more than 1000 calls and emails. Right away it became clear to us that people were confused about what Plan B is and how it works. The largest number of contacts came from people who oppose Plan B on a moral or religious basis and they did not want to listen to facts. In their minds Plan B is an abortion and no amount of scientific information will change their minds. They told us that we were killing babies and were all going to go to Hell.”

In addition, impassioned callers berated college administrators, arguing that they were kowtowing to the demands of a misinformed student body, 85 percent of whom had previously indicated — through a 2008 student survey — that they wanted on-campus access to the drug. “My ‘favorite’ email asked us if we would give dynamite to our students if 85 percent of them wanted it,” he laughs. “It was absurd. What they failed to recognize is that Plan B is legal and available in most pharmacies, without a prescription, to anyone who is over the age of 17.”

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Written by Rabbi Dennis Ross and Rev. Tom Davis for RH Reality Check. This diary is cross-posted; commenters wishing to engage directly with the author should do so at the original post.

The Myth of Judeo-Christian Tradition by Arthur A. Cohen reminds us that no one group speaks for all members of these religions.

The U.S. Department of Health and Human Services (HHS) recently responded to the concerns of some religious groups and individuals by proposing yet another plan to provide prescription birth control insurance coverage under the Affordable Care Act (ACA). Although this HHS initiative respects religious concerns and ensures access to birth control, it received a negative response from the Catholic Bishops, just as the other initiatives had. New York’s Cardinal Timothy Dolan, who is president of the U.S. Conference of Catholic Bishops, explained the rejection, saying, “In obedience to our Judeo-Christian heritage, we have consistently taught our people to live their lives during the week to reflect the same beliefs they proclaim on the Sabbath.”

Now, it would be reasonable to come away from these words thinking that all Jews and Christians are of one mind about birth control — that is to say, opposed. On the contrary, many U.S. rabbis and ministers have long recognized the moral wisdom of ensuring wide availability of safe and effective birth control. Beginning in the late 1920s and the ’30s, many Jewish and Protestant groups formally endorsed access, including rabbis from Reform and Conservative Judaism, and ministers from Episcopal, Baptist, Congregational, Methodist, and Presbyterian churches. Clergy came forward with the support of their faith teachings, underscored by their real-life experience. The pastors were invited into the daily and private lives of congregants to witness, first-hand, that the ability to control one’s child-bearing makes for healthier children and mothers and for stronger families and communities. Today, one thing is certain: Differences in religious teachings remain, and no religious group or leader speaks for all of the nation’s faithful about birth control insurance coverage under ACA.

The recent HHS announcement affects employees of religiously-affiliated hospitals and the like; churches, synagogues, and mosques remain exempt. The reality is that these hospitals are not the same as houses of worship that conduct weddings or confirmations. They are not-for-profit businesses serving the larger public with secular services that are not specifically religious, like setting a broken ankle or performing an appendectomy. What’s more, a hospital employs staff from all walks of life, including faithful individuals in our communities whose fully informed moral decision may lead to a conclusion that differs from the faith of an employer. Besides, these workers earn their insurance along with wages and pension. The insurance belongs to the worker; an employer’s religious objection is irrelevant. A woman’s private decision about her birth control has a higher moral standing than her employer’s problem with her using it. And all we are talking about is insurance paperwork passing quietly through a human resources office — no one is being asked to use birth control.

Notably, the ACA’s birth control insurance provisions resemble those of New York state and California. These insurance requirements, tested in the highest courts of those states, were upheld as an equitable accommodation. And, as clergy, we emphasize that imposing a religious teaching about birth control into the private, personal home life of an American is an egregious violation of church-state separation. But all this is not enough to satisfy birth control opponents.

Arthur A. Cohen’s book, The Myth of the Judeo-Christian Tradition, encouraged a robust dialogue on our religious difference. He argues that the term “Judeo-Christian tradition” represents “a myth which buries under the fine silt of rhetoric the authentic, meaningful, and irrevocable distinction which exists between Jewish belief and Christian belief.” So let’s take Cohen’s advice and recognize that no one religious body or leader represents all Jewish belief — or Christian belief, for that matter. Where religions disagree, policymakers must not play umpire and pick their favorite “team.” Instead, they need to respect the boundary of church-state separation, leave it to the woman to decide about her health care, and ensure her access to the safe and legal preventive medicine she decides she needs.

Cohen calls our religious differences “meaningful.” So let’s ditch the rhetoric, embrace the wonder, grace, and strength of spiritual diversity, and enter a full-hearted and “meaningful” conversation across denominational lines and within religious groups about pressing issues, such as addressing the needs of the poor, the homeless, and immigrants. And let’s take the moral high ground by recognizing that women own their health insurance and deserve protection from the religious objections of others.