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Silencing Debate on Women’s Lives: It’s Happening In Wisconsin, Too, and the Catholic Church Is an Accomplice

11:37 am in Uncategorized by RH Reality Check

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

Redux – The personal is political

Wisconsin State Senator Mike Ellis (R)

Teaching children to understand and cope with bullies is essential, but bullying isn’t limited to elementary school. Bullying may not be physical or direct. It is persistent, intimidating, and it flourishes when victims and witnesses are afraid to speak up or speak out. It is time to identify reproductive coercion for what it is and call the bullies what they are.

Reproductive coercion” includes sabotage of birth control by abusive partners and occurs in all social and economic groups and most frequently to unmarried sexually active women. Male partners seek control over their partner’s reproductive options, even whether and when to have sex, to assert and maintain power.

Just as the pattern of intimidation, harassment, aggression and control is not limited to schools, reproductive coercion is not limited to interpersonal relations. It is ubiquitous at public forums, health care settings, legislative discourse, and campaign politics. This bullying is intended to intimidate, to silence people who disagree, to deny people access to health care they want or need, to pass legislation that denies reproductive justice, and to maintain power by opposing reproductive rights and justice.

Last week, one of Family Planning Health Services’ (FPHS) employees was participating in a health fair sponsored by our local United Way and county health department. It happened to be hosted at a Catholic hospital. One of the medical directors required the employee to remove information on emergency contraception. The doctor then used post-it notes to obscure “prescription contraception” and “non-prescription contraception” on the FPHS display.

The hospital has been recognized for its work with sexual assault victims and the hospital president is on the state attorney general’s sexual assault task force. We can assume the hospital is in compliance with state law to provide emergency contraception in the emergency room and we know that many of the physicians provide prescription and non-prescription contraception to their patients. But, like the classic elementary school bully, the physician used position and status to censor and deny information to participants.

Victims and bystanders might excuse the bully; “I should have known this would provoke him,” or “I should have known better than to be in this neighborhood,” but motivation does not excuse intimidation, bullying and harassment.  On a public level we may understand religious objections, but using status, position, power, volume or force to control someone else’s reproductive health and behavior must be challenged and condemned if the culture of sexual coercion is to change.

Several days ago, Wisconsin’s State Senator Mike Ellis used the power of the majority and the gavel to silence debate and fast-track a bill that requires women to undergo a medically unnecessary ultrasound procedure and morality message before they can have an abortion. In our state assembly, our state representative shared her experience as a child rape victim and spoke very personally to how she felt as a victim and as the mother of three daughters, to a law requiring victims to undergo a re-invasion of privacy and self-control. On-line bullies vilified and harassed her for speaking out as a victim against the “pro-life” legislation.

There are self-styled “prayer warriors” standing outside our family planning clinics for a few months each year. They know that many of our patients and WIC participants/children are intimidated by their presence, but they justify the bullying on the basis of their religious beliefs about abortion, which we do not provide.

Victims and witnesses to reproductive coercion, intimidation and bullying must try to speak up, seek help, or intervene as the situation requires. When it comes to public and political behavior, calling reproductive coercion what it is the first step to ending it.

Obama Administration Ordered to Make Some Forms of EC Available Without Restrictions

6:38 am in Uncategorized by RH Reality Check

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.

Plan B contraceptive wrapper

Judge: Plan B must be available without restrictions.

The Second Circuit Court of Appeals ruled Wednesday that the U.S. Food and Drug Administration (FDA) must immediately comply with an earlier order by U.S. District Court Judge Edward Korman to make some forms of levonorgestrel-based emergency contraception available without a prescription and without point-of-sale or age restrictions.

The ruling came in response to the administration’s request for a stay while it appeals Korman’s order. The Second Circuit’s order, only two pages, is a partial win for women’s health advocates; while it lifts restrictions on two-pill variants of emergency contraception, it grants the Obama administration’s request to stay, or pause, Judge Korman’s order as it applies to one-pill products, such as Plan B One-Step, pending the outcome of the government’s appeal. That appeal will be placed on an expedited schedule as requested by the administration.

In a statement, Nancy Northup, president and CEO of the Center for Reproductive Rights, said: “Today’s decision from the 2nd Circuit marks a historic day for women’s health. Finally, after more than a decade of politically motivated delays, women will no longer have to endure intrusive, onerous, and medically unnecessary restrictions to get emergency contraception.”

The Obama administration appealed Korman’s decision earlier this month, just one day after the Food and Drug Administration (FDA) approved Plan B One-Step to be sold over-the-counter to consumers ages 15 and up. But even that approval was limited, restricting sales to stores that have an on-site pharmacy and only to those with identification. The Plan B approval was in direct conflict with Judge Korman’s April order requiring all emergency contraception be made available over-the-counter and without point-of-sale restrictions.

“Medical experts, the FDA’s own scientists, and a federal court have all agreed: there are no medical grounds to keep emergency contraception behind the counter for any woman” Northrup said. “Expanding access to this safe and effective way of preventing pregnancy after failed birth control or unprotected sex is the among the very best decisions our federal government can make for women’s health.”

A schedule for the full-appeal is not yet available.
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Administration Again Fails on Over-the-Counter Emergency Contraception

10:47 am in Uncategorized by RH Reality Check

Editor’s Note: The Justice Department filed suit to block Judge Korman’s ruling.

The Obama administration said Wednesday that girls under 15 should not have access to the most common morning-after contraceptive pill as the Justice Department filed a notice to appeal a judge’s order that would make the drug available without a prescription for girls and women of all ages.

Written by Editor-in-Chief 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.

This article was amended at 10:16 am, Wednesday, May 1, to correct the date of the amended application by TEVA to the FDA. It was resubmitted in 2012, not 2011.

See all our coverage of EC Over-the-Counter here.

Plan B contraceptive wrapper

New FDA emergency contraception regulations still do not go far enough.

Today, in a proposal that can best be described as adding insult to injury, the Food and Drug Administration (FDA) approved making emergency contraception (EC) available over-the-counter for teens and women ages 15 and up. This convoluted proposal from the Obama administration comes despite a court order in early April by U.S. District Court Judge Edward R. Korman to make EC available over-the-counter to all ages within 30 days of his decision. It comes from an administration which pledged to make science the cornerstone of public policy and instead has consistently flouted a wealth of accumulated evidence on emergency contraception. It also comes after several studies showing that current policy requiring prescriptions for some groups and not others has confused so many pharmacists that access to EC has been denied to many who were in fact legally eligible to obtain it quickly. In practice, the new policy will almost certainly perpetuate, not resolve, that confusion.

The battle to make EC available over-the-counter has gone on for over a decade and spanned both the Bush and Obama administrations. Judge Korman’s ruling was issued in response to the Center for Reproductive Rights’ (CRR) renewed lawsuit against the FDA seeking to expand over-the-counter access for all women to all brands of the morning-after pill, including Plan B One-Step and Next Choice. The most recent CRR lawsuit was filed after Kathleen Sebelius, secretary of the Department of Health and Human Services, overruled a 2011 FDA decision to make emergency contraception available over-the-counter to all ages, underscoring that the Obama administration, like its predecessor, has difficulties dealing with the realities of sex and pregnancy prevention.

The administration’s newest plan is to make EC available over-the-counter to individuals ages 15 and up, but still require prescriptions for those under age 15. While pharmacies can stock it in the family planning section of main store shelves, people seeking to buy EC will have to show identification with a birth date to a cashier. The plan comes after approval this week by the FDA of an amended application submitted by Teva, the manufacturer of Plan B One-Step, to allow OTC sale to those ages 15 and over, after an earlier request to do so had been denied by FDA in December 2011. The amended application was in any case superceded by the scientific evidence that led the FDA to rule in 2011 on making emergency contraception available OTC to all ages, the decision that was, as noted above, subsequently overturned by Sebelius. So in using the approved Teva application as the reason for this newest decision, the FDA is essentially reversing itself and ignoring the science on which its 2011 decision was based. Confused yet? Me too. It’s a complete circus, and I have no doubt that leadership at the FDA, which tried to make evidence-based policy in 2011, came under pressure from the White House to find the “fix” it announced today.

According to the FDA press release:

The product will now be labeled “not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified.” Plan B One-Step will be packaged with a product code prompting a cashier to request and verify the customer’s age. A customer who cannot provide age verification will not be able to purchase the product. In addition, Teva has arranged to have a security tag placed on all product cartons to prevent theft.

In addition, Teva will make the product available in retail outlets with an onsite pharmacy, where it generally, will be available in the family planning or female health aisles. The product will be available for sale during the retailer’s normal operating hours whether the pharmacy is open or not.

NPR reported that “the FDA said … Plan B One-Step will be packaged with a product code that prompts the cashier to verify a customer’s age. Anyone who can’t provide such proof as a driver’s license, birth certificate or passport wouldn’t be allowed to complete the purchase. In most states, driver’s licenses, the most common form of identification, are issued at age 16.”

There are several serious problems with this approach, apart from the fact that it ignores scientific and medical findings that call unequivocally for over-the-counter access for all.

First, the policy is not in compliance with the court ruling and therefore may in fact be thrown out. The Department of Justice will have to bring it before Judge Korman for approval and potentially seek a stay of his ruling altogether, throwing EC once again back to the courts.

Second, it still requires a prescription for a subset of the population potentially in need of EC, and therefore creates a significant barrier, especially for low-income teens under 15 years of age or those without ID who “look” younger and are denied access. Emergency contraception is for emergencies. It prevents unintended pregnancy by preventing ovulation, and is therefore most effective when taken within 72 hours of unprotected intercourse (including in cases when another contraceptive method may have failed). The need to see a physician to obtain a prescription that the public health and medical communities have deemed unnecessary is both time-consuming and expensive, and will entail additional indirect costs in terms of loss of time at school and work, likely on the part of both teens and their parents. This requirement serves the interests of no one except anti-choice opponents of birth control, and those in the Obama administration who still seem unable or unwilling to think beyond their own fears of teens and sex, or to go beyond personalizing policy to accommodate their own paternalistic fears of their daughters as sexual beings.

Third, language, lack of identification, and other potential barriers will remain an obstacle for many communities. Many 15- and 16-year-olds do not have IDs that display birth dates, and those who are well above the age limit but “look younger” to a clerk will be required to produce identification, documentation that many people in this country still do not have readily available or that, in a hurry, some might not remember to bring with them to the store.

Latinas, for example, face many of these barriers to access. In reaction to the decision, Jessica González-Rojas, executive director of the National Latina Institute for Reproductive Health, stated:

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Emergency Contraception and Moral Panic: Dissecting the Newest Misinformation Campaign

1:53 pm in Uncategorized by RH Reality Check

Written by Sidra Zaidi 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 contraceptive wrapper

Plan B emergency is under attack by religious conservatives again.

Reproductive rights advocates have something to cheer about: A federal judge ruled last week that the U.S. Food and Drug Administration (FDA) must allow universal access to Plan B over-the-counter for all ages. But anti-choice proponents want to have the last word on emergency contraception (EC), also known as the morning-after pill. Their strategy to limit access includes claiming that EC is unsafe for adolescents.

After Judge Edward Korman’s ruling, Charmaine Yoest of Americans United for Life said: “This decision allows the abortion industry to gamble with young girls’ health in distributing a life-ending drug, with no real understanding of the long-term implications on their bodies.”

A spokeswoman for the U.S. Conference of Catholic Bishops stated that the court’s action “undermines parents’ ability to protect their daughters … from the adverse effects of the drug itself.”

Once again, the anti-choice community is using inaccurate information to limit women’s and girl’s reproductive rights. There is no evidence that Plan B is a “life-ending drug:” EC is not the abortion pill. It works by preventing or delaying ovulation and does not interfere with implantation of a fertilized egg or with an existing pregnancy.

Nor do any studies demonstrate that EC has “adverse effects” let alone “long-term implications” for girls’ bodies. Plan B is safer than aspirin: It has few or no immediate side effects and no long-term side effects. In fact, the drug meets all of the FDA’s objective criteria for switching a drug from prescription to non-prescription status: It is non-toxic, it is impossible to overdose on it, it has no harmful effects on a woman or teen or a possible pregnancy, and it is not addictive. Girls and women are able to self-diagnose their risk and understand how to use EC from simply reading the label. Finally, Plan B does not require any medical screening or intervention from a health care worker to use it safely.

FDA Commissioner Margaret Hamburg recognized EC’s safety in December 2011 when she confirmed evidence of Plan B’s suitability for all ages without requiring a prescription. What’s more is that her approval for universal over-the-counter EC access has been endorsed by the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the Society of Adolescent Health and Medicine.

Judge Korman also took compelling scientific evidence for Plan B’s safety into account. He wrote in his opinion that Secretary of Health and Human Services Kathleen Sebelius’ countermand of FDA decision-making was “politically motivated, scientifically unjustified, and contrary to agency precedent.”

In 2011, Secretary Sebelius claimed her actions were based on lack of evidence that the drug was safe for girls as young as eleven. Judge Korman was right to counter that “the number of 11-year-olds using these drugs is likely to be miniscule.” A study published last week in Pediatrics bolsters his assertion: According to author Lawrence Finer, only 0.6 percent of 10-year-olds, 1.1 percent of 11-year-olds and 2.4 percent of 12-year-olds have ever had sex.

In the words of the federal judge, claiming that Plan B is unsafe for 11-year-olds is an “excuse to deprive the overwhelming majority of women of their right to obtain contraceptives without unjustified and burdensome restrictions.”

Curiously enough, Secretary Sebelius has made no move to impose an age limit on purchasing aspirin, an over-the-counter drug that is linked to Reye’s syndrome in children under age 16. Nor has the FDA restricted children’s access to energy drinks, despite the fact that over a dozen deaths have been linked to highly-caffeinated beverages that are marketed to youth.

There is no doubt, then, that Secretary Sebelius’ actions to limit EC, one of the safest drugs on the market, were political. The timeline of events indicates as much: The secretary’s FDA override took place in December 2011 immediately before she announced President Obama’s controversial contraceptive mandate one month later

When responding to Judge Korman’s decision, anti-choicers perhaps sensed that evidence-based arguments are effective in the courts. As a result, their offensive tactics have slightly shifted gears from making claims about EC’s safety to arguing that universal EC access potentially coerces girls and increases the risk of untreated STDs.

For example, Anna Higgins, director of the Center for Human Dignity at the Family Research Council, said, “There is a real danger that Plan B may be given to young girls, under coercion or without their consent.”

Donna Harrison of the American Association of Pro-Life Obstetricians and Gynecologists said in a statement, “You’re taking girls at highest risk of STD and isolating them from medical care.”

Harrison’s statement, however, misses the crux of why emergency contraception is important: It is to be used in an emergency. STD education, screening, and treatment are obviously vital components of sexual and reproductive health. Girls who have been sexually violated and potentially exposed to HIV are especially in dire need of HIV prophylaxis. But there is no conclusive evidence that providing EC to adolescents increases their risk of STDs or contributes to a rise in risk-taking behavior. Moreover, if a girl fears that she may become pregnant, she must be able to access EC as soon as possible — Plan B is most effective within 72 hours, and only up to five days, after unprotected sex.

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Court Orders FDA to Make Emergency Contraception Available Over-the-Counter for All Ages

11:42 am in Uncategorized by RH Reality Check

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.

Plan B Vending Machine Survives Anti-choice Misinformation Campaign

2:09 pm in Uncategorized by RH Reality Check

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 contraceptive wrapper

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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No Plan B: Why Is the Indian Health Service Denying Native American Women Access to Emergency Contraception?

7:17 pm in Uncategorized by RH Reality Check

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

Published in partnership with the American Independent.

Plan B contraceptives

Why is Levonorgestrel (Plan B) contraception unavailable to Native American women?

“No, ma’am,” says the pharmacy tech over the phone at the Choctaw Nation’s health clinic in Hugo, Okla., when I ask if the clinic carries emergency contraception.

At the Pokagon Band of Potawatomi Health Services clinic in Dowagiac, Mich., the pharmacy tech who answers the phone tells me the clinic does not carry Plan B or any other emergency contraceptive that can prevent pregnancy up to 72 hours following unprotected sex, failed contraception, or sexual assault. And no, she doesn’t know the nearest place to get any.

The person filling in at the Black Hawk Health Center in Stroud, Okla., after checking with staff, tells me the clinic does not carry any emergency contraceptive. He suggests trying Stroud Drug or the Walgreens or CVS in Edmond, about an hour drive from Stroud. I could also try the Walmart in Shawnee, he says.

I learn from the Citizen Potawatomi Nation tribal clinic in Shawnee that it does not carry emergency contraception either; though again, I’m referred to Walgreens, CVS, and Walmart.

Were I a Native American woman — which I’m not — I would have less incentive to go to a retail pharmacy like one at Walmart or CVS. Because at a pharmacy affiliated with the Indian Health Service — a federal agency that provides health services for American Indians and Alaska Natives — emergency contraception, like most medication, would be free. And even if I did have the fifty or so dollars it might cost for the so-called “morning-after pill,” I might not have a way to get to a retail pharmacy, if I don’t have a car or if I live on an isolated reservation.

About a month ago, I reproduced an informal phone survey originally conducted last September by the Native American Women’s Health Education Resource Center, based in Lake Andes, South Dakota. I called the same 63 centers (though I was not able to reach every one), all funded by IHS, asking the questions asked in the original survey: Does your pharmacy carry Plan B or another emergency contraceptive? And is it offered over the counter? I did not identify myself as a reporter.

Though some of the pharmacies contacted in that original survey, and in my own reproduction, said they offered emergency contraception over the counter, more often pharmacy techs or pharmacists said that either their clinics offered the drug by prescription-only, or not at all. In all, the NAWHERC study found that only 11 percent of the pharmacies surveyed carried emergency contraception over the counter, about half carried emergency contraception but required a prescription and a doctor’s visit, and about 43 percent of the pharmacies contacted did not carry Plan B at all.

In 2006, the Food and Drug Administration approved the over-the-counter use of Plan B for women 18 and older. In 2009, the FDA approved the over-the-counter use of Plan B and the updated Plan B One-Step, as well as a generic version of Plan B called Next Choice, for women 17 and older. And last year, the agency approved the generic Next Choice One Dose to be taken without a prescription for the same age group. (Other, prescription-only forms of emergency birth-control have been approved by the FDA, as well.)

According to the Centers for Disease Control and Prevention, if taken within 72 hours of unprotected sex, Plan B reduces the risk for pregnancy by at least 75 percent.

But for many Native American women, it can be difficult to obtain emergency contraception over the counter, which can in turn diminish the chances that the drug will prevent an unintended pregnancy. The time to schedule a doctor’s appointment, attend the appointment, obtain a prescription, and fill that prescription — and the fact that many IHS and tribal clinics close after 5 p.m. and during weekends — further reduces access to the drug.

A 2012 study assessing the accuracy of information on emergency birth control provided to teens and their physicians, published in the journal Pediatrics, noted that “with every 12-hour delay in taking the first EC dose after unprotected intercourse, the odds of pregnancy increase by nearly 50 percent. Therefore, even minor delays in obtaining EC substantially increase the likelihood of pregnancy.”

Native women’s advocates spent the better part of 2012 calling for the Indian Health Service to implement a standardized policy on obtaining emergency contraception without a prescription. The agency has made no official move on this requested policy and has remained largely silent on the issue, repeatedly giving me and other reporters vague responses, to the effect that IHS is “in the process” of standardizing its procedures, without confirming any specific plans.

However, communications provided to me reveal that IHS claimed to be working on a policy months ago.

In the face of silence on when women can expect improved access to emergency contraception on tribal lands, Native women’s advocates — led by NAWHERC Executive Director Charon Asetoyer and consultant Pamela Kingfisher — have taken it upon themselves to help tribal communities learn more about their right to a reproductive health service enjoyed by the rest of the country. They have been collaborating with tribal groups across the nation, hosting workshops and roundtables with women’s shelter workers and community leaders, and pestering government officials for answers on any upcoming policies.

“I think it’s upon us women now to challenge our leadership, to step up and stand up for women, especially if the federal government is not going to do it,” said Kingfisher, a member of the Cherokee Nation in Oklahoma.

‘Moccasin telegraph’

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Political “Science:” The Ongoing Battle Over Emergency Contraception

8:56 am in Uncategorized by RH Reality Check

(photo: us-mission/flickr)

(photo: us-mission/flickr)

Written by Claire Cooper for RH Reality Check. This diary is cross-posted; commenters wishing to engage directly with the author should do so at the original post. This article is published as part of our 2012 Back Up Your Birth Control series.

The influence of politics on science and women’s health was once again on full display late last year. In December 2011, Secretary of Health and Human Services (HHS) Kathleen Sebelius blocked the U.S. Food and Drug Administration’s (FDA) approval of Plan B One-Step’s over-the-counter (OTC) status. It would have been the first time emergency contraception (EC) would be available without a prescription for women of all ages. Instead, it was the first time a HHS secretary overrode the FDA’s decision to approve a medication.

While Secretary Sebelius’ decision to intervene and block Plan B One-Step’s OTC status was shocking on several fronts—given the mounds of scientific evidence proving EC as safe and effective for adolescents and this Administration’s pledge to scientific integrity—those of us at the Center for Reproductive Rights saw it as “déjà vu all over again.”

We’ve been battling the FDA’s politicization of EC for over a decade—trying to hold the FDA accountable in federal court for treating EC differently than any other medication.

The Center initially filed a Citizen Petition with the FDA in 2001, on behalf of over 70 medical and public health organizations, asking the agency to grant OTC status to all levonorgestrel-based emergency contraception products available at the time.

Because the FDA failed to respond appropriately to both the Citizen Petition and applications from EC drug manufacturers, the Center filed a lawsuit in 2005 asserting that the FDA violated its own procedures, as well as statutory and regulatory mandates, by refusing OTC status for EC.

After the suit was filed, the FDA finally agreed to make Plan B, the leading two-pill EC brand at the time, available to women 18 and older without a prescription. But it remained behind the pharmacy counter and required government-issued identification.

By this time, it had become clear that politics was dictating the FDA’s decisions regarding EC. Four years after our lawsuit was filed, the federal court agreed and ordered the FDA to immediately grant OTC status to Plan B for women age 17 and older, and ordered the agency to reconsider the 2001 Citizen Petition.

It took another two years (and a motion for contempt) before the FDA asserted that it would resolve the issues raised by the Citizen Petition by reviewing a supplemental new drug application (SNDA) for Plan B One-Step, a one-pill EC brand submitted for OTC approval in February 2011. The SNDA sought to switch Plan B One-Step to OTC status for women of all ages. That application’s approval was blocked by Secretary Sebelius in December, even though the FDA had concluded: Read the rest of this entry →

Teen Immaturity Is Not the Problem with Plan B. The Immaturity of Politicians Is.

11:56 am in Uncategorized by RH Reality Check

Plan B (photo: vixyview/flickr)

Plan B (photo: vixyview/flickr)

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

Teenagers get a lot of crap for going above, under, and around the laws that are established to keep them “safe.” Some of these laws are completely well-founded. Others are not.  President Obama and Kathleen Sebelius, betrayed millions of teens and young people (along with their doctors, parents, and supportive adults) by telling them that they were not mature enough to decide to prevent a pregnancy.

As a recent teenager, I want to set the record straight on some things that our politicians may not have realized. Teenagers do have the maturity to know how and when to take Plan B. Teenagers know that emergency contraception is what you use when the condom breaks, when pulling out doesn’t go as planned, when contraception wasn’t available. They know it can stop pregnancy from occurring and that they shouldn’t wait until Monday when they MAY be able to go to the doctor to get a prescription.

Because let’s face it, sex for teenagers happens more often when their parents are out for the night, when they don’t have school the next morning, and when they have the most free time. Monday isn’t going to cut it and while teenagers may want to go to the pharmacy and pick up Plan B because they want to protect themselves or their partners from becoming pregnant, they can’t. Not because they are going to abuse it, not because they don’t know how to use it, not because they lack the maturity to know what consequence the lack of action could have, but because politicians have deemed that it’s immoral to let teenagers to access Plan B. They are denying teenagers access to something that could help them continue being teenagers, because isn’t that what every parent, neighbor, and president wants?

Teenagers under 17, who can’t legally access Plan B, do sometimes have access to it. The majority of people that I know who have used Plan B were not 17 and they didn’t go to a doctor to get a prescription to get emergency contraception. Teenagers know that there are faster ways to get Plan B and so, while millions of adults don’t have the maturity to admit simple (or big) mistakes, teenagers admit to their friend, their sibling, their cousin that they messed up and they need that person to buy them or their partner emergency contraception. These teenagers use their birthday, babysitting, or lawn- mowing money to buy a $50 pill that will prevent a pregnancy and enable them to continue being teens. Read the rest of this entry →

After the EC Decision, A Lifelong, Third Generation Democrat Wonders Where She Belongs

11:50 am in Uncategorized by RH Reality Check

Kathleen Sebelius (Photo: americanprogress, flickr)

Kathleen Sebelius (Photo: americanprogress, flickr)

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

See all our coverage of Kathleen Sebelius’ 2011 Emergency Contraception Reversal here.

President Obama visited Osawotamie, KS on Tuesday and gave a speech about the economy.  His speech focused on fair play, fair shares and fair shots for all citizens.  I went to Osawotamie to ask the President to extend that message of fairness to the women of the nation, regardless of the religious affiliation of their employer.  I went to the speech to represent the interests of a coalition consisting of Planned Parenthood of Kansas and Mid-Missouri, MoveOn.org and Kansas NOW.  The following is from our press release…

President Obama has continually spoken out about his administration’s commitment to women and women have supported the President in many of his initiatives, including the passage of the Affordable Care Act.

We stand united in Kansas, encouraging the President to honor his commitment to all women by standing in firm opposition to the expansion of the conscience clause of the birth control mandate within the Affordable Care Act.

Peter Brownlie, President and CEO of Planned Parenthood of Kansas and Mid-Missouri said, “President Obama should reject efforts to take away the birth control coverage benefit from millions of Americans who work at religiously-affiliated hospitals, universities, schools, or organizations.  These are nurses, teachers, janitors, and other workers who should not be discriminated against and denied a benefit that the vast majority of Americans will receive.”

Kari Ann Rinker, State Coordinator of Kansas NOW stated, “We ask the President to stand up to the U.S. Conference of Catholic Bishops and other opponents of contraception and just say no to the continued bullying of corporate religious interests, whose demands run counter to the individual conscience of the millions of women who could potentially be effected by this expansion. The President’s vague answers and lack of official statement on this subject is disconcerting.” Read the rest of this entry →