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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.

Read the rest of this entry →

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.

Emergency Contraception Should Be Available Over The Counter. And You Can Make That Happen

11:56 am in Uncategorized by RH Reality Check

Written by Kirsten Moore 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 on the shelf - in Canada.

Last week’s announcement from the esteemed American College of Obstetricians and Gynecologists (ACOG), suggesting it’s time to make oral contraceptives accessible without a prescription, is the perfect way to re-ignite and re-engage public conversation about making emergency contraception (EC) available without restriction. We cannot afford another decade of political delays when it comes to common sense measures to improve women’s health.

Doctors are taking the lead by acknowledging they’ve become unnecessary obstacles between women and their birth control. That is an example politicians need to follow. Medical science, not political ideology, should govern which products are safe and effective. It is clear women of all reproductive ages will be better off when emergency contraception is easily accessible and in their hands.

One year ago next week the Food and Drug Administration was poised to announce that EC had been approved for on-the-shelf access, such that it could appear at your local pharmacy between condoms and pregnancy test kits. But Health and Human Services (HHS) Secretary Kathleen Sebelius stepped in at the last minute and ruled that Plan B One-Step and its generic equivalent must remain behind-the-counter. That decision led to confusion and unnecessary obstacles for women, teens, and couples at the very moment clarity was needed most. For example, we know that:

  • Doctors and teens have been given misinformation about the age restrictions applied to emergency contraception over the counter (currently 17) or told that teens could not get the product at all (not true). This confusion helps no one.
  • Men have been told by pharmacists in several states around the country that they could not buy EC (not true), presenting obstacles and delays when timing matters.
  • Rape survivors have been denied access to EC by doctors and prison staff.
  • Individuals without government issued identification may have difficulty accessing EC because of the restrictions.

In addition to the practical confusion the Sebelius ruling created, it also set a dangerous policy precedent. Never before has HHS overruled the FDA on a product that had been as thoroughly vetted and researched as EC. To the extent the concern about teens accessing EC was something the Obama Administration didn’t want to have to deal with during the election, they should clearly understand now that the women, young voters, and communities of color who stood in line at the polls did so in part because access to contraception, and the choice it represents in all our lives, is important.

For example, today 82 percent of teen pregnancies are unintended. Seventy percent of  teens in New York City who became pregnant between 2011-2012, dropped out of school Increased, evidence-based access to EC  could give these teens a second chance to prevent pregnancy and stay in school. But research reveals that because of widespread confusion, 50 percent of teens seeking EC were told the wrong age requirements for buying it. 

The science supporting EC hasn’t changed, but the politics sure have. We need to send a clear signal to Secretary Sebelius that women’s reproductive health and medical science should be the driving force behind public policy. A broad coalition of medical professionals and advocates is launching a petition today to urge Secretary Sebelius to revisit the evidence and remove the restrictions.

Please sign it and share it with your friends. Engage people in conversation about the important issues on social media and help demonstrate the strong consensus for common sense public policy that puts health and science over political ideology. We want to get as many signatures as possible before the one-year anniversary of the Sebelius decision on December 7th, please sign, share, and continue to make your voice heard.

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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 →