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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.

Texas Abortion Drug Bill Could Mean More Side Effects and Higher Costs

12:51 pm in Uncategorized by RH Reality Check

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

CORRECTED December 20, 2012, 12:41PM ET: This story originally said the mifepristone drug label was last revised in 2005. In fact, minor revisions were made to the label in 2009, but the FDA’s protocol for using the medication wasn’t changed.

Published in partnership with The American Independent.

A GOP lawmaker is looking to make Texas the latest state to restrict the use of abortion medications in a way that some experts warn could increase the drugs’ side effects while making them more expensive.

Anti-choice activists and legislators can’t enact an outright ban on abortion-inducing drugs like mifepristone (formerly known as RU-486). Instead, they have sought to force doctors to strictly adhere to U.S Food and Drug Administration guidelines that appear to be significantly out of step with the current scientific understanding of how the medications should be used.

Lawmakers have passed abortion drug restrictions in Arizona and Ohio, overcoming legal challenges. The Oklahoma Supreme Court recently ruled that similar legislation in that state was unconstitutional. A North Dakota bill is currently tied up in litigation.

In Texas, state Sen. Dan Patrick’s bill, which mirrors model legislation drafted by anti-choice group Americans United for Life, would require doctors who prescribe an abortion drug to follow the protocol outlined in the official drug label approved by the FDA. He introduced similar legislation in 2011 — with the AUL’s support — but it didn’t pass. Patrick also authored the state’s controversial pre-abortion sonogram law.

In most state’s, doctors aren’t required to abide by the FDA guidelines. And since the FDA only regulates the drug market and not the practice of medicine, “off-label” treatment isn’t against federal law either. In fact, the FDA itself notes that physicians may prescribe a medication off-label as long as they are well informed about the product and “base its use on firm scientific rationale and on sound medical evidence.”

AUL insists that off-label use of mifepristone “can be deadly.” While Patrick did not respond to interview requests from The American Independent, he “said the intent of [the bill] is to improve the doctor-patient relationship” in an email to the Texas Tribune. But the legislation’s strict adherence to the FDA guidelines worries reproductive health care advocates and medical experts. They say a substantial body of recent research shows that the mifepristone drug label is outdated, potentially creating unnecessary burdens, financial costs, and health risks for women.

During a medical abortion, mifepristone is given to the woman at the clinic. The second round of medicine, misoprostol, is taken a day or two later to help end the pregnancy.

The FDA guidelines say that women should take 600 milligrams of mifepristone. But 2012 World Health Organization guidelines recommend a lower dose of mifepristone. Citing several studies, the report states that “200 mg of mifepristone is the dosage of choice, since it is as effective as 600 mg, and reduces costs” when it is followed by a dose of misoprostol.

Some of the language in Patrick’s bill is ambiguous, but it appears that it would also require women to receive their second dose of abortion pills — the misoprostol — in the presence of her doctor rather than at home, where it is typically taken. A number of reproductive health advocates find that rule troubling.

According to the National Abortion Federation, the majority of women who take mifepristone will abort within four hours of using misoprostol. Because of this, most women choose to take the misoprostol dose in the comfort of their own home due to painful side effects such as cramping and excessive bleeding that can also occur within the first few hours. Nausea, vomiting, and fever are among the other side effects women may experience, according to NAF.

“Women want to plan for the expelling of this fluid and blood tissue at their own time and they want to be in a comfortable place,” said Elizabeth Nash, state issues manager with the reproductive health and policy-based Guttmacher Institute. “So you can understand why a woman would want to take the medicine at home, especially if she has a fair distance to travel, which could happen in a place like Texas.”

The FDA guidelines and, apparently, Patrick’s bill do not give women the option of taking the second drug at home.

But the medical consensus has evolved in recent years. Unlike the old FDA guidelines, the 2012 WHO guidelines say that “[h]ome use of misoprostol is a safe option for women.”

Similarly, abortion drug guidelines set forth in 2005 by the American Congress of Obstetricians and Gynecologists say that the lower 200-milligram dose of mifepristone is as effective as the higher, FDA-approved dosage and that “multiple large studies in the United States have demonstrated that a patient can safely and effectively self-administer the misoprostol … in her home.” The ACOG guidelines note that the alternate drug regimens were developed in an effort to “reduce side effects” and “make medical abortion less expensive, safer, and more rapid.”

Dr. Mitchell Creinin, who worked on the ACOG guidelines and currently chairs the Department of Obstetrics and Gynecology at the UC-Davis, says the FDA-approved regimen is “outdated” and that the “vast majority” of providers follow the updated protocol.

The FDA guidelines don’t just stipulate when and where the woman can take the abortion drugs, but how. Misoprostol is only approved by the FDA for oral use, says Creinin, whereas research has shown that ingesting a higher dose of the medicine buccally (placing the pill in between your teeth and cheek) or vaginally can, in some instances, decrease side effects and work faster and more effectively — especially as the pregnancy advances.

According to ACOG, the new protocol is effective for women who have been pregnant for up to 63 days; by contrast, the FDA guidelines limit the use of mifepristone to the first 49 days of pregnancy.

The proposed law could also place significant financial and logistical burdens on women. At roughly $100 for each 200-milligram pill, the FDA’s higher mifepristone dosage is expensive. Moreover, Texas already mandates an ultrasound at least 24 hours before an abortion, so the legislation would actually require four separate trips to the doctor (for the ultrasound, the mifepristone, the misoprostol, and a follow-up visit.)

Texas OB-GYN and abortion provider Dr. Bernard Rosenfeld says the FDA guideline requiring women to take the misoprostol in a clinic was meant to standardize a variable in the trial and that several subsequent studies have shown women can safely take it at home.

Rosenfeld, who has practiced medicine for more than three decades, says the rule goes against “good medical practice” and advises all his patients to take the pills at home.

“There is zero medical basis or benefit to take the pills in the clinic,” he said. “To make a woman come back to the doctor’s office and then find a way to get back home after taking the drug is really just mean and cruel and puts them at medical risk.”

“It’s really just meant to give women a hard time,” he added.

The bill also compels doctors to create a contract with another physician who promises to treat the woman should an emergency arise from the drug. The doctor must have “active admitting, gynecological and surgical privileges at the hospital designated to treat the emergency.” But because some women, especially those in rural areas, may have to travel far to receive an abortion, the hospital in which the admitting doctor works may not be the closest to the woman in the event of a medical emergency.

“Living in a small, rural town can be really problematic for a woman seeking an abortion under these rules,” said Nash. “This part is not well thought out. It does not think through what actual steps will be best for the patient.”

The legislation seeks to penalize doctors who do not follow the requirements. According to the bill, the Texas Medical Board may take disciplinary action, such as revoking a medical license, or assess an administrative penalty, which can mean a fine of up to $5,000 if a doctor fails to comply.

‘More dangerous and more expensive’

Anti-choice lawmakers promote the use of outdated FDA rules when it comes to abortion-inducing drugs as a way to stigmatize doctors, says Nash.

“Whenever you invoke the FDA guidelines you are essentially making it wrong to do something that doesn’t abide by them. But in reality, what we are talking about is off-label protocol that is less expensive and has fewer side effects,” she said.

Anti-choice advocates disagree. Dr. Donna Harrison, a pro-life doctor and director of research and public policy at the American Association of Pro-Life Obstetricians and Gynecologists, says the rigorous FDA process should be followed.

“The FDA guidelines are the only real safeguard for the American people,” she said.  ”So when you go off-label with the drug, you are experimenting on women.”

But doctors in many medical fields routinely prescribe off-label drugs. A 2006 study found that an estimated one-in-five drug prescriptions were off-label.

A 2007 study found that 79 percent of pediatric patients discharged from the hospital received off-label drugs. Off-label drugs are also commonly used in cancer treatments. According to a 1997 survey of 200 cancer doctors conducted by the American Cancer Society and the American Enterprise Institute, 60 percent of them prescribed off-label drugs to patients.

“Off-label use is pretty much the mainstay of how we use medicine in the U.S.,” says Creinin, pointing to everything from birth control regimens to anxiety medication. “Just because a drug is approved by the FDA doesn’t mean there aren’t better ways to use it after approval. Research continues on the drug and finding new uses and assigning different dosages is normal.”

“The bill is really about trying to make providers look as though they are not following the rules when in fact, [the more recent protocol] is just as safe and effective and actually has additional benefits,” said Nash.

Creinin is skeptical of legislators’ intentions.

“The question here is: why would lawmakers, who say they are looking out for the health and welfare of their constituents, want to legislate that women must follow the label when sufficient medical literature shows the old guidelines are more dangerous and more expensive?” he said. “What they’re really trying to say is that they know more than the doctor – but they really need to be getting out of this business.”

‘No medical benefit whatsoever’

Dr. Lisa Perriera, a fellow with Physicians for Reproductive Choice and Health in Ohio, is familiar with the legislation. She says that after her state passed its own law in 2004 restricting use of mifepristone, she began to see unfortunate consequences. For example, patients have reported back that after receiving their misoprostol dose in the clinic, they begin to experience uncomfortable side effects while driving home from the clinic.

“We have patients that have to travel as far as five hours in a car while the abortion process starts – that’s just not fair,” said Perriera.

Based on her experience, Perriera says the legislation has not deterred her patients from having abortions; it has simply affected how they have them. As a result of the seven-week gestational limit, more of them have switched to surgical abortions.

“Some women want to have abortions naturally, without medical instruments, but this bill would eliminate that option for them,” she said. “Legislating the way women have to take their medicine is taking choices away from them.”

In the end, the rules have made it “more inconvenient for patients and more costly,” said the Ohio physician.

“It is also forces women to undergo more visits for no medical benefit whatsoever,” said Perriera. “So this is really not about their health and safety.”

Vulnerable Women and Contraception: Obama Turns Clock Back Nearly 100 Years

3:31 pm in Uncategorized by RH Reality Check

Written by Carole Joffe 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 the Administration’s 2011 Emergency Contraception Reversal here.

“For a woman to ‘ask her physician’ for a safe and effective contraceptive  presupposed that she had a physician, that she could afford a contraceptive, and that the physician would be willing to give it to her, regardless of her marital status.”

These are the words of the historian Sheila Rothman, writing about the setbacks Margaret Sanger faced in the 1920s and 1930s in trying to realize her vision of making birth control widely available to all women, including the poorest—and about the ultimate “ownership” of contraceptive services during that era by physicians. Sanger’s original vision was a fleet of clinics, to be run by public health nurses. But as Rothman and others have documented, when she attempted to open such clinics, she experienced repeated arrests and the closures of her facilities, as contraception was then illegal. In the years leading up to the 1965 Supreme Court Griswold decision, which legalized birth control for married persons, only physicians were legally permitted to provide such services, and as the quote from Rothman implies, this situation put poor women at a tremendous disadvantage.

Rothman’s critique, written in the 1970s about events in the ‘20s and ‘30s,  is remarkably relevant to today’s leading reproductive controversy: the Obama administration’s overruling of the FDA decision to allow over-the-counter status of Plan B, an Emergency Contraceptive product, for young women under the age of seventeen. If one substitutes “teenager” for “woman” and “Plan B” for “a safe and effective contraceptive” in Rothman’s quote, one can readily appreciate how, once again in America’s longstanding reproductive wars, the needs of the most vulnerable are willfully neglected.

Secretary of Health and Human Services Kathleen Sebelius and President Obama justified the Administration’s action because of concerns about pre-teens’ ability to use EC correctly. But as been repeatedly observed, only a tiny portion of this age group is sexually active.  It is 15- and 16-year-olds who are sexually active in far greater numbers, and therefore, far likelier to have need of EC (and to be able to use it correctly). But many in this group do not have a primary health care provider to whom they can go for a prescription.  Some of those who do have a relationship with a provider may be too embarrassed, or afraid of a breach of confidentiality, to ask for such a prescription.

To be sure, some things have improved in the contraceptive world since the dominance of private practice physicians in Margaret Sanger’s time. In 1970, Congress authorized the Title X program, which made federal funds available for family planning services for poor women including, notably, teenagers. (As a sign of how much the reproductive battle lines have hardened in the last 30 years, Title X was signed by a Republican president, Richard Nixon, and one of its most enthusiastic sponsors in Congress was a future Republican president, George H.W. Bush). A number of contraceptive products are available on the shelves of drugstores.

And it is no longer just physicians who can advise and dispense contraception. In public health clinics and Planned Parenthood facilities, nurses are in fact the main providers of contraception. We can hope that some portion of those teenagers who need EC can find their way to a Planned Parenthood or other Title X site in the three day window in which the drug is most effective.

But this recent decision of the Obama administration on EC occurs, of course, in an atmosphere in which Republicans in Congress are attempting to abolish Title X, and various states have defunded Planned Parenthood, leading to a closing of numerous clinics. The reproductive wars drag drearily on—and in our times, as in Sanger’s, the most vulnerable of women pay the greatest price.

“For a woman to ‘ask her physician’ for a safe and effective contraceptive  presupposed that she had a physician, that she could afford a contraceptive, and that the physician would be willing to give it to her, regardless of her marital status.” “For a woman to ‘ask her physician’ for a safe and effective contraceptive  presupposed that she had a physician, that she could afford a contraceptive, and that the physician would be willing to give it to her, regardless of her marital status.”

Denying OTC Access to Plan B Disproportionately Affects Latina Teens

3:25 pm in Uncategorized by RH Reality Check

Written by Jessica Gonzalez-Rojas 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 the Administration’s 2011 Emergency Contraception Reversal here.

This article was changed at 12:05 pm on Tuesday, December 13th.  The original mis-identified the author. It is Jessica Gonzales-Rojas. We apologize for the error.

Last month a ten-year-old girl in Puebla, Mexico gave birth, via c-section, to a premature infant. The girl says her stepfather raped her repeatedly. She only spoke out about the abuse after she gave birth when the glare of public attention gave her some measure of safety. Her stepfather immediately disappeared. This story has received wide attention in the Spanish language press and has sparked anger across Latin America.

I immediately thought of the girl from Puebla last week when President Obama expressed concern that an 11-year-old might go to a drugstore and purchase emergency contraception along with “bubble gum and batteries” because the drug could “have an adverse effect.” The image of a young child casually purchasing birth control was used to describe the “common sense” reasoning behind his administration’s refusal to allow the FDA to make emergency birth control available to young women below the age of seventeen. President Obama invoked the image of his daughters when discussing the drug store scenario, but I imagined the girl from Puebla, standing at the checkout counter with birth control, bubble gum and batteries in her hands. The profound injustice of her life brought me to tears, and the trivialization of her situation, as if girls at age ten would be purchasing birth control with the same weight that they would purchase the bubble gum, is enraging.

Whether President Obama was compelled to weave the bubble gum narrative for political gain or because it truly reflects his thinking, the result is the same. Complex sexual health issues get overly simplified, society focuses on stigma more than solution, and young people are left with policy decisions that don’t begin to match the weight of their lived experiences nor keep them “safe.”

What is repeatedly lacking in our narratives about adolescent sexual health is a human rights perspective. If our society were to seriously contemplate how to help children who are victims of sexual abuse, it would not be to make birth control access harder for teens. This tunnel vision ignores the complex social factors that foster abusive environments, and ignores the dignity and justice that every child deserves.

A real discussion about emergency contraception would focus on addressing the real needs of teens. Yet due to the structural barriers that our politicians and healthcare industry have erected, most Latina teens will not realistically be given this last chance to prevent an unintended pregnancy. More than any other racial or ethnic group, Latinas lack health insurance and their households struggle economically. Teens without health insurance or money will need to seek out a healthcare provider to write a prescription, collect the $50 for the co-payment to fill the prescription, and to take the pills within three days of unprotected intercourse. Furthermore, Latina teens that encounter additional barriers due to their immigration status or limited English-language proficiency are even more isolated. No one reasonably believes this is a recipe for success.

There has always been strong political interference in FDA rule making about emergency contraception. Politicians simply can’t let scientists and public health experts do what’s best for our young people. That’s why years ago the National Latina Institute for Reproductive Health was a plaintiff in a federal lawsuit (Tummino v. Hamburg), which resulted in the court directing the FDA to make emergency contraception available to teens age seventeen and above. And that’s why today our lawyers from the Center for Reproductive Rights will be back in federal court fighting against the continued political interference in healthcare access for younger teens.

A Young Doctor’s Response to President Obama’s Plan B Failure: Where Is the Scientific Integrity?

11:34 am in Uncategorized by RH Reality Check

Broken Caduceus (Photo: truthout/flickr)

Broken Caduceus (Photo: truthout/flickr)

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

Cross-posted in partnership with Amplify Your Voice. See all our coverage of Kathleen Sebelius’ 2011 Emergency Contraception Reversal here.

Like most of the pro-choice community, I was shocked by Secretary Sebelius of the Department of Health and Human Services overruling the FDA’s decision to make Plan B over-the-counter and available for all ages. This was unexpected, unprecedented, and extremely unfortunate.

Experts, who we count on for guidance and sound evidence-based medicine, have repeatedly shown Plan B to be not only extremely effective, but incredibly safe. Although the experts in the FDA agreed with the well-researched and well-presented data on Plan B, Secretary Sebelius and President Obama chose to ignore their expertise and base their decision on politics, not science.

Not only is this infuriating, but hypocritical. A certain document found on WhiteHouse.gov by The Obama Administration dated March 9, 2009 expresses quite the different sentiment. Interestingly, this release from The White House Press Secretary is entitled “Scientific Integrity” and the first line states “[s]cience and the scientific process must inform and guide decisions of my Administration on a wide range of issues, including improvement of public health…”

I suppose I missed the footnote that implied exceptions for family planning.

As I read the press releases on Secretary Sebelius’ decision and the news about President Obama’s unwavering support of her overruling, I could not help but pick apart their few but telling remarks:

President Obama stated that ten- to 11-year-olds would be able to buy Plan B next to “batteries and bubble gum,” potentially putting these young girls at risk for adverse events if they did not use Plan B correctly. Interestingly, Tylenol is over-the-counter and far more dangerous with far more potential for adverse outcomes. Oh, and pregnancy in a ten- to 11-year-olds also has FAR more adverse outcomes than a small, but effective dose of Plan B. Read the rest of this entry →

Disappointed Doesn’t Cut It Anymore: A Mother’s Rebuttal of President Obama’s Plan B Politics

1:38 pm in Uncategorized by RH Reality Check

Written by Kate Stewart 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.

Disappointed doesn’t cut it anymore.

Disappointed, angry, dismayed — these are only some of the emotions I am feeling this afternoon after hearing President Obama’s poor excuse for restricting access to Plan B One Step.

I am also scared.

Scared about the health of my daughters.  As the mother of two daughters, just like President Obama, I try to use “common sense” as much as possible. But, also like President Obama, I am not a doctor; I am not a scientist. I use my own judgment when it comes to things I am confident I can handle — a case of the sniffles, a little cold.

But, I also understand that it is my responsibility as a parent to know when I don’t know all the answers and it’s time to turn to experts. And that, apparently, is where the President and I disagree.

When my daughter’s pediatrician gives me medical advice, I listen. Carefully. American Academy of Pediatrics and the Society of Adolescent Health and Medicine make recommendations about my daughters’ health, that matters to me. A lot. And I believe it should.

Today, President Obama has made the irresponsible – and nearly incomprehensible — decision to support HHS Secretary Kathleen Sebelius’ move to block the FDA from expanding access to Plan B One-Step emergency contraception. Whether the President’s decision was motivated by well-intentioned ignorance or political cowardice is beside the point. Either way, this move will adversely impact millions of women, particularly young women, across the country.

President Obama has decided to ignore scientific research and medical advice and has sacrificed the health of young women. And I want to know why. Why, Mr. President? Why would you reject years of research and the best scientific thinking the medical community has to offer? Why, for the first time in U.S. history, did your administration intervene to overrule the FDA’s ability to make decision about medical science? 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 →

Denying Access to Plan B: An Act of Political Cowardice

11:43 am in Uncategorized by RH Reality Check

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

Fool me twice. I’m an idiot.

I keep thinking someone in this administration is going to take a stand that will mean something.

It’s a small thing, really, but a huge thing when you’re a teenager. You need access to emergency contraception and you can’t get it because your government is controlled by fundamentalist body haters who think that sex is for procreation only.

*****

I’m still hunting for the right words to say. Nearly 40 years after abortion was made legal in this country, 50 years since we’ve had the Pill, and women are still told, day-after-day, that the only thing that matters about them is their ability to bear children. And if bearing a child costs you your life, well, what greater sacrifice can you make? (And besides, there are plenty of women to replace you.)

*****

To visit the local cemeteries is to see this philosophy carved in stone–acres of stones that tell the same story. One man will be buried with two, often three, wives. He died in his 80s. The first two wives died in their 20s or early 30s, but the third wife grew old with him. Frequently, there are newborns whose death dates approximate the death dates of their mothers.

We tell ourselves that this was before modern medicine. That puerperal fever, or ruptured uteri, or hearts weakened by childhood diseases and then too weak to bear the strains of pregnancy, that these things are all things of the past.

But, we maintain maternal mortality statistics because pregnancy is still potentially deadly. And lest any American think that we have the best health care system in the world, ask yourself why our rates of maternal death are among the highest in the industrialized world?

****

The FDA cannot find a single reason why Plan B contraception can’t be on a shelf where anyone can buy it. Katherine Sebelius, and her boss, Barack Obama, they moved the football again.

We were all so happy when Obama chose a pro-choice champion to head HHS. But, it turns out, just like her boss, she’s a political coward.

So what, the right wing thinks teenagers shouldn’t be having sex? How has that changed in all the years that we’ve been talking about it?

Sebelius, no doubt ordered to by her boss, overruled the FDA, denied scientific evidence, to make moralistic assholes happy.

I really thought you were going to hold the football steady this time, Obama. I really did.

I’m an idiot. I keep hoping against hope that you’re not going to throw women under the bus. That you can stand up to the ladies who swoon at the Concerned Women for America. You think they’re going to vote for you because you said no to Plan B?

I know you’re not stupid.

You’re a coward.

Pushing the Boundaries for Women’s Health: Why Over-the-Counter Access for the Pill Makes Sense… Now

6:56 am in Uncategorized by RH Reality Check

Written by Kirsten Moore and Aimee Thorne-Thomsen for RHRealityCheck.org – News, commentary and community for reproductive health and justice.

RH Reality Check is partnering with key sexual and reproductive health and justice organizations to examine the facts on birth control methods.  See also the article by Erica Sackin, "Just Facts: Will the Pill Make me Fat?"

In recent weeks, the blogosphere has been buzzing over the prospect of an over-the-counter (OTC) switch for a daily oral contraceptive regimen. Amanda Marcotte recently took on the topic in “The Pill: A Counter to "Over-the-Counter," raising many valid questions about the timing, purpose, and effects of an OTC switch. This is an issue that the Reproductive Health Technologies Project and other women’s health advocates have examined for more than a decade. The decision to move forward at this point in time in support of a switch comes after thoughtful discussion and careful examination of the scientific evidence and other relevant considerations.

The bottom line is this: we believe an OTC switch for a birth control pill would increase access to contraception by providing a highly effective, woman-controlled option that can be obtained without a trip to the doctor’s office, and the difficulties that often entails. We think this will be good for women. And it may even have the potential to transform the way we think about birth control by decreasing stigma and normalizing contraceptive use.

Medically speaking, the case is strong for OTC access. Birth control pills are a safe, effective medication used by over 10 million women in the United States alone, and the pill has 50 years of global data backing it up. Women can easily decide whether they are candidates for pill use (“Do I want to get pregnant or not?”). Birth control pills aren’t addictive, and you can’t overdose. While contraindications, especially hypertension, present a concern, labeling, advertising, and public education campaigns could be used to close the information gap and encourage women to seek regular preventive care. A recent study shows that with the proper information and support women can screen themselves for contraindications nearly as well as providers do.

Most concerns about contraindications apply specifically to combined oral contraceptives, making a progestin-only pill (POP) the most likely candidate for a switch. As Kelly Blanchard points out in “Let the Pill Go Free,” POPs have fewer and rarer contraindications and potential complications. This is confirmed by the newly released CDC guidelines on medical eligibility for contraceptive use. In fact, one formulation of a progestin-only pill is already available over-the-counter for women 17 and older—as emergency contraception (EC) products Plan B® and Next ChoiceTM.

But there is more to a switch than medical statistics. In fact, for many advocates the most important question is: How would an OTC switch make a difference in women’s lives?

Let’s look at young women for example. For young women, an OTC option could be a game-changer. It would begin to close the gap in contraceptive access created by the stigma and shame associated with being sexually active. This stigma can prevent young women, and young women of color in particular, from seeking or continuing medical care with a doctor or other provider. We know from research by the Pro-Choice Public Education Project that many young women do not feel comfortable talking with their doctors about their sexual and reproductive health, and “may be more inclined to forgo a checkup than risk the possible humiliation or stress of a doctor’s visit.” Prescription-only access means that forgoing a checkup may also mean interrupting use of birth control pills, or never starting them at all.

Societal stigma also acts as a barrier to access for young women or any woman who feels she may be judged for being sexually active. When you don’t want to be “found out,” it can be difficult or impossible to access birth control from an on-campus health center, Planned Parenthood clinic, or local family doctor for fear that “everyone will know” the reason. The ability to buy a pill pack from nearly any pharmacy or grocery store could be transformative for women for whom other sources are not acceptable or available.

An OTC option could also help to close the gaps in contraceptive use created by changing circumstances in a woman’s life. A survey by the Guttmacher Institute found that for more than half of women who had a gap in contraceptive use of at least one month, the gap in use “coincided with an important life event, such as the beginning or ending of a relationship, a move to a new home, a job change or a personal crisis.” Understandably, getting an appointment with a provider can be especially difficult in these situations, and an OTC birth control pill would provide a highly-effective method that is easier to start or continue during chaotic times.

We know that an OTC switch will not meet the needs of every woman, and that both prescription and over-the-counter options have benefits and limitations. Ultimately, it is difficult to predict all the outcomes of an OTC switch. This is partially because the causes of contraceptive nonuse and unplanned pregnancy are incredibly complex, and partially because we won’t know until we try.

Maybe it isn’t the perfect time to pursue an OTC switch. But in our experience, there is rarely a perfect moment to initiate change. We are in the business of transforming women’s lives for the better, and we cannot afford to wait for policymakers to roll out the red carpet or for the opposition to step out of the way. Improving women’s access to reproductive health care is not easy, and not always popular: that’s exactly why it’s so important.

We hope health care reform will mean more women have better health insurance coverage, including coverage for reproductive health care and contraception, though the reality remains to be seen. Yet, even under the most optimistic implementation scenario, there will still be problems with access. Our health care system is already overburdened, under resourced, and precariously reliant on a workforce aging toward retirement. As millions of newly-insured Americans become eligible for care, it is unclear whether this system will be able to meet the demand.

The OC OTC Working Group recognizes that a successful path for a switch involves tackling the policy question of how OTC products are covered (or not covered) by public and private insurance. The Working Group also takes seriously the importance of women’s access to a full range of preventive health services and information. Confronting these challenges will require successful partnerships between insurers and advocates, significant legislative or administrative policy change, and the allocation of public and private resources in a manner that prioritizes women’s health. We also recognize that these questions are much bigger than an OTC switch for a single pill formulation.

We know it won’t be easy. We bring to this campaign the lessons learned from the fight for an OTC switch for Plan B. Women’s health advocates, led by the inspiration of Sharon Camp, made that happen. Most people didn’t believe it would actually go over-the-counter and of course, for some, it still hasn’t. But for many women, we were able to expand access. Just as important, we were able to advance a positive message about being sexually active and taking charge of your life. We anticipate that pushing for an OTC birth control pill with further test the boundaries of our society’s comfort and sense of normalcy around sex—and we welcome the challenge.

FDA Committee Agrees Ella is Safe and Effective

7:10 am in Uncategorized by RH Reality Check

Written by Jodi Jacobson for RHRealityCheck.org – News, commentary and community for reproductive health and justice.

This afternoon, the Advisory Committee for Reproductive Health Drugs of the Food and Drug Administration confirmed that, based on the evidence, a new emergency contraceptive method, known as ella, is safe and effective at pregnancy prevention up to 120 hours after unprotected sex or contraceptive failure.

The committee also recommended that labeling not restrict access to the method.

In a statement, Planned Parenthood Federation of America (PPFA) applauded the committee’s vote.

According to PPFA:

The full FDA approval of UPA, a medication that can be used safely and effectively up to five days after unprotected intercourse, would provide women with more options to prevent unplanned pregnancies. This promising new emergency contraception, which, if approved, will be sold under the brand name “ella,” is already being used in Europe by women to prevent pregnancy up to five days after unprotected intercourse.

“Today’s vote by the FDA advisory committee that ella is safe and effective as a form of emergency contraception is a commonsense recommendation made by scientific experts,” said Cecile Richards, president of PPFA. “There are many reasons why a woman may face the risk of unintended pregnancy — from failure or improper use of birth control, to sexual assault — and every woman deserves every option available to prevent an unplanned pregnancy.”

“At Planned Parenthood, doctors, nurses and clinicians encourage women and men to consider their health and lifestyle factors when determining which contraceptive method is best for them and their partners.  We know that birth control is most effective when women and men make informed decisions and get the contraceptive method that is most appropriate for them,” said PPFA Vice President of Medical Affairs, Dr. Vanessa Cullins.

“We want all of our patients to have as many safe and effective options to chose from as possible when they are either trying to prevent pregnancy over the long term or in emergency situations.”

"Ella, or UPA, is safe and effective at preventing ovulation and therefore pregnancy in the five days after unprotected intercourse,” added Cullins. “Given the fact that half of all pregnancies in the U.S. are unintended, it is vital that women have an array of choices available to prevent unplanned pregnancy. Ella will become an important option for women.”

Kirsten Moore, President and CEO of the Reproductive Health Technologies Project, stated:

"We appreciate the committee’s unanimous consensus that labeling should not contain restrictions on access to the product. The ball is now in FDA’s court to quickly complete their review and approve this safe and effective product that gives women a chance to prevent unintended pregnancy."

Read more about ella in Alicia Johnson’s article "FDA Should Act Quickly to Approve New Emergency Contraceptive."