News Contraception

In Astounding Move, HHS Secretary Kathleen Sebelius Overrules FDA Recommendation to Make Plan B Over-the-Counter

Jodi Jacobson

In what can only be called an astounding move, today Kathleen Sebelius, Secretary of the Department of Health and Human Services (HHS) overruled a much-awaited decision by the U.S. Food and Drug Administration (FDA) to make emergency contraception (EC) available over-the-counter (OTC) to women of all ages. No HHS Secretary has ever before overruled an FDA decision, according to the New York Times.

See all our coverage of the Administration’s 2011 Emergency Contraception Reversal here.

This article was corrected at 1:15 pm, Thursday, December 8th, 2011.  The earlier version incorrectly stated that EC was available for women ages 18 and older without prescription.  It is available without prescription for women 17 and older.

In what can only be called an astounding move by an Administration that pledged on inauguration day that medical and health decisions would be based on fact not ideology and for which women are a major constituency, today Kathleen Sebelius, Secretary of the Department of Health and Human Services (HHS) overruled a much-awaited decision by the U.S. Food and Drug Administration (FDA) to make emergency contraception (EC) available over-the-counter (OTC) to women of all ages.

According to the New York Times, “no health secretary has ever [overruled an FDA decision] before.”

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EC has been available over-the-counter for women ages 17 and older for at least two years.  The FDA has been further reviewing data on whether the method should be available OTC without a prescription to those age 17 and younger at risk from unprotected intercourse.

In a statement this afternoon FDA underscored that it “had been carefully evaluating for over a decade whether emergency contraceptives containing levonorgestrel, such as Plan B One-Step, are safe and effective for nonprescription use to reduce the chance of pregnancy after unprotected sexual intercourse.”

Experts, noted the statement, “including obstetrician/gynecologists and pediatricians, reviewed the totality of the data and agreed that it met the regulatory standard for a nonprescription drug and that Plan B One-Step should be approved for all females of child-bearing potential.”

“I reviewed and thoughtfully considered the data, clinical information, and analysis provided by the Center for Drug Evaluation and Research (CDER),” wrote Dr. Margaret Hamburg, head of the FDA and author of the statement, “and I agree with the Center that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.”

However, she wrote:

[T]this morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential. Because of her disagreement with FDA’s determination, the Secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved.  Following Secretary Sebelius’s direction, FDA sent the complete response letter to Teva today.  Plan B One-Step will remain on the market and will remain available for all ages, but a prescription will continue to be required for females under the age of 17.

Why?

I have one word. P.O.L.I.T.I.C.S.

If we have been reminded of one thing in the past several months, it is that politicians and religious leaders alike will, when it suits them, marginalize the rights and needs of women to advance their own interests and need for power. And somewhere, someone in the Obama Administration, perhaps the president himself, gave the cue to HHS to overrule the FDA decision. And clearly, as she sometimes did as governor of Kansas, Sebelius did the deed.

Because apparently the health and rights of women do not matter, but placating the far right does. Because apparently helping teens actually prevent unintended pregnancies isn’t an authentic a goal of this administration. Perhaps it was among the topics on which President Obama came to “understand the concerns of Catholics [read the 281 bishops],” as Archbishop Timothy Dolan assured the New York Times after his private meeting with the president.

Because the evidence is indisputably in favor of the FDA’s decision

CDER reviewed all the evidence on use of EC by younger women. Its findings?

CDER carefully considered whether younger females were able to understand how to use Plan B One-Step.  Based on the information submitted to the agency, CDER determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.  [Emphasis added.]

But no amount of proof it seems can make up for the fact that, despite all the evidence, even President Obama and Secretary Sebelius appear to think young women are too stupid to make their own decisions or that they are just chum to be thrown to the religious right in an election year.

As the saying goes, with friends like these, who needs the far right?

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Follow Jodi Jacobson on Twitter: @jljacobson

News Contraception

Native American Women Still Don’t Have Access to OTC Emergency Contraception

Martha Kempner

It's been two years since the FDA made certain types of emergency contraception available without a prescription to women of all ages, but Indian Health Service has yet to update its policy.

When the Food and Drug Administration (FDA) in 2013 approved over-the-counter access to certain emergency contraceptive pills without any age restrictions, Indian Health Service (IHS) promised that it would update its policies to make this pregnancy-prevention method available in the pharmacies it runs.

Two years later, the IHS policy remains the same, and a group of U.S. senators last week sent a letter to the secretary of Health and Human Services, Sylvia Mathews Burwell, urging her to look into the matter.

Emergency contraception (EC) is a high dose of hormones that can prevent pregnancy by preventing ovulation if taken within three to five days of unprotected intercourse. The sooner it is taken, the better it works, which is why immediate access without a prescription is so important.

Efforts to win FDA approval for over-the-counter status, however, took the better part of a decade with opponents falsely suggesting that emergency contraception causes abortions (it will not, in fact, affect an established pregnancy) and arguing that making it readily available—especially to teens and young women—will increase promiscuity.

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One of the available versions of EC—marketed as Plan B One-Step—was approved in July 2009 for over-the-counter sale, but such sales were limited to women 17 and older. Younger women still needed a prescription.

The age restriction was dropped to 15 in April 2013. Finally, in June 2013 the FDA—complying with a district court ruling—declared that Plan B One-Step would be available without a prescription for “all women of reproductive potential,” regardless of age.

At the time, a group of lawmakers led by Sen. Barbara Boxer (D-CA) reached out to then U.S. Secretary of Health and Human Services (HHS) Kathleen Sebelius urging her to create a long-term solution that would ensure EC was available over the counter in pharmacies run by the IHS.

Sebelius and her staff replied, promising that they were already working on updates to IHS pharmacy policy. So far, however, no policy has been released.

Boxer’s staff recently conducted a survey of 20 IHS pharmacies and found that EC was not readily available. Some pharmacies did not offer EC at all, others still required a prescription, and others wouldn’t provide it to certain women based on their age.

A similar survey by the Native American Women’s Health Education Resources found that access to EC varied widely at 69 IHS centers.

This is particularly disturbing because Native American women who rely on these health centers often live in rural areas where access to other health care and even pharmacies is limited. As the American Civil Liberties Union (ACLU) points out, “The nearest commercial pharmacy may be hundreds of miles away.”

The ACLU also notes that access to EC is particularly important to Native American women because they face rates of sexual assault that are more than twice as high as other women in this country. EC is often given to sexual assault survivors to reduce the chance that they will become pregnant from their attack.

Last week, to try to spur action, Sens. Boxer, Patty Murray (D-WA), Jon Tester (D-MT), Richard Blumenthal (D-CT), Tammy Baldwin (D-WI), and Maria Cantwell (D-WA) wrote another letter to HHS.

“We request that you share the steps your Department has taken towards updating its policy and provide a clear timeline for when that process will be completed,” the letter reads. “Further, we ask that you share with us data from surveys of pharmacies the IHS has undertaken in order to assess access to emergency contraception and the steps that the Department and IHS plan to take to monitor patient access moving forward. We appreciate your consideration of this request.”

“Native American women have waited too long for access to emergency contraception, which is now much more easily available to women across the country,” the ACLU wrote. “The federal government is legally and morally obligated to ensure that these women and communities are not left behind.”

Commentary Abortion

11 Pro-Choice Successes of 2013

Rewire Staff

Though 2013 might have brought an array of new abortion restrictions and other setbacks for reproductive rights, there were also a number of reasons for pro-choice allies around the country to be proud this year. The staff of Rewire notes some of the top pro-choice successes of 2013.

Though 2013 might have brought an array of new abortion restrictions and other setbacks for reproductive rights, there were also a number of reasons for pro-choice allies around the country to be proud this year. Below, the staff of Rewire notes some of the top pro-choice successes of 2013.

1. The “feminist army” rose up in Texas.

How could a steamy Texas summer that saw the passage of some of the harshest abortion restrictions in the country be considered a great moment in reproductive rights? Because of the thousands of Texans who descended upon the state capitol building, clad in orange, to speak out against a bill that, when fully implemented, is expected to close all but six abortion clinics in the state. Average Texans took time off work and made the sometimes hours-long trip to Austin, day after day. They organized a “people’s filibuster,” testifying through the night in front of occasionally hostile right-wing legislators, paving the way for state Sen. Wendy Davis (D-Fort Worth) to pull off her remarkable 13-hour filibuster. Davis forced Gov. Rick Perry to call a third special session to force the law’s passage, but even today, the “orange army” doesn’t let up: Nearly 20,000 Texans refused to back down in the face of callous conservative politics and asked state health officials to mitigate the impact of the laws, continuing the fight for reproductive autonomy in the Lone Star State. —Andrea Grimes

texas listicle

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2. North Carolina residents turned out in droves—and in costume—to fight anti-choice legislation.

This year, some plucky progressives in very-red North Carolina pushed back against the idea that there’s anything “moral” about denying women birth control or safe abortion care. Under the thunderously charismatic leadership of North Carolina NAACP President William Barber, “Moral Monday” protesters came every week to give legislators headaches over voter restrictions, their refusal to expand Medicaid, and attacks on workers and public schools. But rolling back women’s rights really took the cake, and a few dozen protesters soon swelled to over 2,000 when state legislators snuck onerous abortion restrictions into a motorcycle safety bill. To top that off, protesters dressed as Mad Men characters to remind legislators that it’s total turn-back-the-clock crazy-talk to argue over whether women should have full access to birth control in 2013. —Emily Crockett

Picture via Planned Parenthood of Central North Carolina.

Picture via Planned Parenthood of Central North Carolina.

3. The Obamacare birth control benefit allowed many U.S. women to access contraception without a co-pay.

A whole lot of people stopped paying “lady taxes” for birth control in 2013.

Because of the Affordable Care Act, the number of privately insured individuals who don’t have a co-pay for birth control pills went from 15 percent to 40 percent! (And the percent of those women who are sluts stayed at zero.)

Thanks, Obama! —Erin Matson

4. Judge Edward R. Korman issued a smackdown on emergency contraception.

Despite a mountain of evidence on the safety of emergency contraception and the public health benefits to making it widely available, for at least a decade the federal government caved to pressure from the religious right and refused to make emergency contraception available over-the-counter and without age restrictions. But the Obama administration took political posturing on emergency contraception (EC) to a new level when Secretary of Health and Human Services Katherine Sebelius overruled the Food and Drug Administration’s own recommendation under the Obama Administration to lift sales restrictions and blocked widespread EC access. In April, a federal district court judge called the administration out on it in one of the most searing legal opinions of the year. Comparing the administration’s efforts to restrict the sale of emergency contraception to voter identification efforts, and accusing them of basing political decisions on their discomfort with the idea of teenagers having sex, Judge Edward Korman’s decision not only held the administration accountable for playing politics with women’s health—it was the first step in ending the protracted legal and political battle with the government over EC access. —Jessica Mason Pieklo

5. California expanded abortion access with new legislation.

Amid a sea of legislation restricting access to safe, legal abortion around the country this year, there was one state that bucked the national trend: California. In October, Gov. Jerry Brown signed a law allowing nurse practitioners, certified nurse midwives, and physician assistants to perform first-trimester abortions in the state, greatly expanding access to abortion care for women. —Lauren Kelley

California grungy stamp shutterstock_151919099 [Converted]

6. Albuquerque residents and grassroots organizers defeated anti-choice ordinance.

Last month, Albuquerque residents voted down an ordinance that would have banned all abortions after 20 weeks’ gestation in the city. The real-world impact of the ordinance would have been much broader, however, as Albuquerque is home to one of only four clinics in the entire country that openly provides later abortions. Credited with defeating the ordinance is a broad coalition of grassroots organizers, who worked to inform and connect with voters, and get as many folks to the polls as possible. —Lauren Kelley

respect ABQ women

7. Reproductive rights supporter Nina Pillard was confirmed to the D.C. Circuit Court of Appeals.

It only took changing the way the Senate did business for over 100 years in response to obstruction efforts unheard of even by Republican standards, but pro-choice advocates finally have an answer to far-right Judge Janice Rogers Brown on the D.C. Circuit Court of Appeals. Georgetown Law professor Cornelia “Nina” Pillard, who has been called the next Ruth Bader Ginsburg, has a history of fighting for reproductive autonomy and gender equality. And considering the D.C. Circuit Court of Appeals is often a stepping-stone to a Supreme Court gig, the impact of Pillard’s confirmation could last for decades. —Jessica Mason Pieklo

Nina Pillard during Sen. Ted Cruz’s Q&A at her nomination hearing.

8. SCOTUS stays out of Oklahoma’s medication abortion and ultrasound laws.

The U.S. Supreme Court punted in Oklahoma this year by refusing to hear appeals of blocks to two high-profile laws that would have piled on abortion restrictions in the Sooner State. In early November, the Court dismissed the state’s appeal to reinstate a law the Oklahoma Supreme Court ruled unconstitutional because it would have effectively banned medication abortion. About a week later, it refused to hear a challenge to the Oklahoma Supreme Court’s decision blocking the state’s ultrasound law, which would have forced every Oklahoman seeking an abortion to undergo a narrated ultrasound exam and to have the ultrasound image placed in front of her. The decision to leave in place the Oklahoma Supreme Court decisions blocking those restrictions suggests the Roberts Court is inclined to stay out of many of the fights over incremental restrictions on abortion rights. That’s good news for Oklahoma, but may not be such good news for places like Texas. —Sofia Resnick

9. Several states saw at least temporary legal wins against anti-choice laws.

2012 and 2013 may have seen a flood of draconian anti-choice restrictions, but it also saw a flood of litigation in response. In states like Arkansas and North Dakota, lawmakers passed blatantly unconstitutional laws that would ban abortion in some cases as early as six weeks. In Mississippi and Wisconsin, lawmakers attacked abortion access in targeted regulation of abortion providers (TRAP) laws designed to close clinics and drive providers out of the state. So far, courts have blocked those laws from going into effect while a lawsuit over their constitutionality proceeds. So we’re filing this one away in the “it could have been worse” category and keeping our eyes on these cases for 2014. —Jessica Mason Pieklo

10. West Virginia pro-choice advocates came out strong going into what could be a brutal year for reproductive rights attacks.

Hundreds of West Virginians protested this summer against what they see as Attorney General Patrick Morrissey’s brewing assault on reproductive rights. Morrissey, who is openly anti-choice, appears to be gearing up for an assault on abortion clinics in 2014’s legislative session. But local pro-choice groups have mounted a strong fight, which has already led to some embarrassing setbacks, including prominent anti-choice activists losing lawsuits they’d brought against doctors. “We’ve seen what’s happened in Texas, North Carolina, and Ohio,” said Margaret Chapman Pomponio, executive director of WV Free, a nonprofit organization that promotes reproductive rights and justice. “We’re saying the buck stops here.” —Sharona Coutts

11. Arizona abortion ban was permanently blocked.

In May, the Ninth Circuit Court of Appeals permanently blocked an Arizona law that would have banned all abortions at 20 weeks, except in cases of life-threatening medical emergencies. Passed in 2012, the law was intended to test the strength of viability as the point at which a state can restrict or ban access to abortion under Roe v. Wade. Sharply criticizing the district court, which had found that the law does not prohibit all abortions after 20 weeks’ gestation, but merely regulates them, the Ninth Circuit called the law unconstitutional. The court further pointed out that any ability of fetuses to feel pain at 20 weeks’ gestation did not give Arizona an overriding interest to prohibit pre-viability abortions. —Imani Gandy