Over-the-Counter Emergency Contraception? The FDA Saga Continues

Jodi Jacobson

Are you tired of waiting for the FDA to get its head out of you-know-where and finally approve over-the-counter sales of emergency contraception?  Then let them know.

Editor’s note: Portions of this article were edited at 9:15 pm, Thursday February 10th, 2011 to cut out repetitive paragraphs.

Are you tired of waiting for the FDA to get its head out of you-know-where and finally approve over-the-counter sales of emergency contraception without restrictions?

Me too. 

After all, every scientific finding out there supports OTC sales without age restrictions.

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Did you think that this would have been done already, given our President promised in his very inaugural speech to restore “scientific integrity” to policy in the United States?  After 8 long years of hocus pocus?

Me too.

After all, we’re ostensibly all on board with the plan to reduce unintended pregnancies and the need for abortion, right?  (Yes, I know, not all of us, but the ones that voted for this Administration.)

Then why are we still waiting for the FDA to approve this method?  And why are politics still involved in women’s health care under an ostensibly pro-choice, pro-science administration also ostensibly committed to reducing unintended pregnancies??

Why are we still fighting the government for our rights to access effective methods of birth control?

Two years ago, a court found that the FDA’s decision to limit access to EC was based on politics rather than science and ordered the agency to reconsider its decision.

According to the Center for Reproductive Rights (CRR), in March 2009, Judge Edward Korman of the U.S. District Court for the Eastern District of New York found that the FDA’s prior decision to limit access to Plan B was based on politics rather than science and ordered the agency to reconsider that decision.  The FDA ignored this court order and continues to do so. On November 16, 2010, the Center asked the court to hold the agency in contempt for ignoring the court’s ruling and to order the FDA to make a decision within a specified amount of time.  The FDA acknowledged the court order, but subsequently took the position that the best way for it to comply with the order is to wait for a new application from the drug manufacturer.

Today, Teva, the manufacturer of one form of emergency contraceptive known as Plan B filed an application with the FDA requesting that Plan B be made available over-the-counter without a prescription for women of all ages.  That sounds very nice but since Teva’s application will only apply to Plan B, advocates fear the FDA will take a piecemeal approach, requiring that companies file a separate application for every other type of emergency contraception (there are four kinds) to be eligible for over-the-counter, all-ages status, rather than ending all  restrictions on all forms of emergency contraception once and for all as the science indicates should be done.

CRR has been fighting this fight for ten years

Work started on this case in 2001 and CRR officially sued the FDA in 2005 for failing to grant over-the-counter status to EC against the advice of its scientific experts and in violation of its own procedures and regulations. But that was during the Bush Administration. The FDA later agreed to make EC available without a prescription, but only to women 18 and over and only behind the pharmacy counter. The Center continued to pursue its case because there are no medical grounds for denying young women access to emergency contraception.

In a statement today, CRR called out the FDA–again–for balking:

While the Center supports all actions to make emergency contraception more readily available to women, we want to make it clear to the FDA that Teva’s application doesn’t mean that they’re off the hook. While we support any action to increase access to EC, let us be clear: Teva’s application does not excuse the FDA of its responsibility to women and the law.

This is a medical and public health no-brainer.

Each year, about six million pregnancies occur in the United States. About half occur among women who did not plan on having a baby, otherwise known as unintended pregnancies.  Half the time, according to Princeton University, it is because birth control failed, meaning that the contraceptive itself didn’t work or that a woman and her partner made a mistake when they were using it. The other half of the time, the couple wasn’t using any method of birth control.

Using emergency contraceptive pills (also known as “morning after pills” or “day after pills”) in the first few days after sex reduces the risk of getting pregnant by at least 75%, giving a woman a second chance to prevent pregnancy if her birth control failed, she had sex without using contraception, or she was forced to have sex.

Making emergency contraception available and informing women about it can help them prevent an unintended pregnancy and reduce the need for abortion.

Like I said: No-brainer.

Who or what is the FDA afraid of?

The Center wants your help to make them very afraid…. of you.

Go to their petition page to send a message to the FDA.

Analysis Politics

The 2016 Republican Platform Is Riddled With Conservative Abortion Myths

Ally Boguhn

Anti-choice activists and leaders have embraced the Republican platform, which relies on a series of falsehoods about reproductive health care.

Republicans voted to ratify their 2016 platform this week, codifying what many deem one of the most extreme platforms ever accepted by the party.

“Platforms are traditionally written by and for the party faithful and largely ignored by everyone else,” wrote the New York Times‘ editorial board Monday. “But this year, the Republicans are putting out an agenda that demands notice.”

“It is as though, rather than trying to reconcile Mr. Trump’s heretical views with conservative orthodoxy, the writers of the platform simply opted to go with the most extreme version of every position,” it continued. “Tailored to Mr. Trump’s impulsive bluster, this document lays bare just how much the G.O.P. is driven by a regressive, extremist inner core.”

Tucked away in the 66-page document accepted by Republicans as their official guide to “the Party’s principles and policies” are countless resolutions that seem to back up the Times‘ assertion that the platform is “the most extreme” ever put forth by the party, including: rolling back marriage equalitydeclaring pornography a “public health crisis”; and codifying the Hyde Amendment to permanently block federal funding for abortion.

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Anti-choice activists and leaders have embraced the platform, which the Susan B. Anthony List deemed the “Most Pro-life Platform Ever” in a press release upon the GOP’s Monday vote at the convention. “The Republican platform has always been strong when it comes to protecting unborn children, their mothers, and the conscience rights of pro-life Americans,” said the organization’s president, Marjorie Dannenfelser, in a statement. “The platform ratified today takes that stand from good to great.”  

Operation Rescue, an organization known for its radical tactics and links to violence, similarly declared the platform a “victory,” noting its inclusion of so-called personhood language, which could ban abortion and many forms of contraception. “We are celebrating today on the streets of Cleveland. We got everything we have asked for in the party platform,” said Troy Newman, president of Operation Rescue, in a statement posted to the group’s website.

But what stands out most in the Republicans’ document is the series of falsehoods and myths relied upon to push their conservative agenda. Here are just a few of the most egregious pieces of misinformation about abortion to be found within the pages of the 2016 platform:

Myth #1: Planned Parenthood Profits From Fetal Tissue Donations

Featured in multiple sections of the Republican platform is the tired and repeatedly debunked claim that Planned Parenthood profits from fetal tissue donations. In the subsection on “protecting human life,” the platform says:

We oppose the use of public funds to perform or promote abortion or to fund organizations, like Planned Parenthood, so long as they provide or refer for elective abortions or sell fetal body parts rather than provide healthcare. We urge all states and Congress to make it a crime to acquire, transfer, or sell fetal tissues from elective abortions for research, and we call on Congress to enact a ban on any sale of fetal body parts. In the meantime, we call on Congress to ban the practice of misleading women on so-called fetal harvesting consent forms, a fact revealed by a 2015 investigation. We will not fund or subsidize healthcare that includes abortion coverage.

Later in the document, under a section titled “Preserving Medicare and Medicaid,” the platform again asserts that abortion providers are selling “the body parts of aborted children”—presumably again referring to the controversy surrounding Planned Parenthood:

We respect the states’ authority and flexibility to exclude abortion providers from federal programs such as Medicaid and other healthcare and family planning programs so long as they continue to perform or refer for elective abortions or sell the body parts of aborted children.

The platform appears to reference the widely discredited videos produced by anti-choice organization Center for Medical Progress (CMP) as part of its smear campaign against Planned Parenthood. The videos were deceptively edited, as Rewire has extensively reported. CMP’s leader David Daleiden is currently under federal indictment for tampering with government documents in connection with obtaining the footage. Republicans have nonetheless steadfastly clung to the group’s claims in an effort to block access to reproductive health care.

Since CMP began releasing its videos last year, 13 state and three congressional inquiries into allegations based on the videos have turned up no evidence of wrongdoing on behalf of Planned Parenthood.

Dawn Laguens, executive vice president of Planned Parenthood Action Fund—which has endorsed Hillary Clinton—called the Republicans’ inclusion of CMP’s allegation in their platform “despicable” in a statement to the Huffington Post. “This isn’t just an attack on Planned Parenthood health centers,” said Laguens. “It’s an attack on the millions of patients who rely on Planned Parenthood each year for basic health care. It’s an attack on the brave doctors and nurses who have been facing down violent rhetoric and threats just to provide people with cancer screenings, birth control, and well-woman exams.”

Myth #2: The Supreme Court Struck Down “Commonsense” Laws About “Basic Health and Safety” in Whole Woman’s Health v. Hellerstedt

In the section focusing on the party’s opposition to abortion, the GOP’s platform also reaffirms their commitment to targeted regulation of abortion providers (TRAP) laws. According to the platform:

We salute the many states that now protect women and girls through laws requiring informed consent, parental consent, waiting periods, and clinic regulation. We condemn the Supreme Court’s activist decision in Whole Woman’s Health v. Hellerstedt striking down commonsense Texas laws providing for basic health and safety standards in abortion clinics.

The idea that TRAP laws, such as those struck down by the recent Supreme Court decision in Whole Woman’s Health, are solely for protecting women and keeping them safe is just as common among conservatives as it is false. However, as Rewire explained when Paul Ryan agreed with a nearly identical claim last week about Texas’ clinic regulations, “the provisions of the law in question were not about keeping anybody safe”:

As Justice Stephen Breyer noted in the opinion declaring them unconstitutional, “When directly asked at oral argument whether Texas knew of a single instance in which the new requirement would have helped even one woman obtain better treatment, Texas admitted that there was no evidence in the record of such a case.”

All the provisions actually did, according to Breyer on behalf of the Court majority, was put “a substantial obstacle in the path of women seeking a previability abortion,” and “constitute an undue burden on abortion access.”

Myth #3: 20-Week Abortion Bans Are Justified By “Current Medical Research” Suggesting That Is When a Fetus Can Feel Pain

The platform went on to point to Republicans’ Pain-Capable Unborn Child Protection Act, a piece of anti-choice legislation already passed in several states that, if approved in Congress, would create a federal ban on abortion after 20 weeks based on junk science claiming fetuses can feel pain at that point in pregnancy:

Over a dozen states have passed Pain-Capable Unborn Child Protection Acts prohibiting abortion after twenty weeks, the point at which current medical research shows that unborn babies can feel excruciating pain during abortions, and we call on Congress to enact the federal version.

Major medical groups and experts, however, agree that a fetus has not developed to the point where it can feel pain until the third trimester. According to a 2013 letter from the American Congress of Obstetricians and Gynecologists, “A rigorous 2005 scientific review of evidence published in the Journal of the American Medical Association (JAMA) concluded that fetal perception of pain is unlikely before the third trimester,” which begins around the 28th week of pregnancy. A 2010 review of the scientific evidence on the issue conducted by the British Royal College of Obstetricians and Gynaecologists similarly found “that the fetus cannot experience pain in any sense prior” to 24 weeks’ gestation.

Doctors who testify otherwise often have a history of anti-choice activism. For example, a letter read aloud during a debate over West Virginia’s ultimately failed 20-week abortion ban was drafted by Dr. Byron Calhoun, who was caught lying about the number of abortion-related complications he saw in Charleston.

Myth #4: Abortion “Endangers the Health and Well-being of Women”

In an apparent effort to criticize the Affordable Care Act for promoting “the notion of abortion as healthcare,” the platform baselessly claimed that abortion “endangers the health and well-being” of those who receive care:

Through Obamacare, the current Administration has promoted the notion of abortion as healthcare. We, however, affirm the dignity of women by protecting the sanctity of human life. Numerous studies have shown that abortion endangers the health and well-being of women, and we stand firmly against it.

Scientific evidence overwhelmingly supports the conclusion that abortion is safe. Research shows that a first-trimester abortion carries less than 0.05 percent risk of major complications, according to the Guttmacher Institute, and “pose[s] virtually no long-term risk of problems such as infertility, ectopic pregnancy, spontaneous abortion (miscarriage) or birth defect, and little or no risk of preterm or low-birth-weight deliveries.”

There is similarly no evidence to back up the GOP’s claim that abortion endangers the well-being of women. A 2008 study from the American Psychological Association’s Task Force on Mental Health and Abortion, an expansive analysis on current research regarding the issue, found that while those who have an abortion may experience a variety of feelings, “no evidence sufficient to support the claim that an observed association between abortion history and mental health was caused by the abortion per se, as opposed to other factors.”

As is the case for many of the anti-abortion myths perpetuated within the platform, many of the so-called experts who claim there is a link between abortion and mental illness are discredited anti-choice activists.

Myth #5: Mifepristone, a Drug Used for Medical Abortions, Is “Dangerous”

Both anti-choice activists and conservative Republicans have been vocal opponents of the Food and Drug Administration (FDA’s) March update to the regulations for mifepristone, a drug also known as Mifeprex and RU-486 that is used in medication abortions. However, in this year’s platform, the GOP goes a step further to claim that both the drug and its general approval by the FDA are “dangerous”:

We believe the FDA’s approval of Mifeprex, a dangerous abortifacient formerly known as RU-486, threatens women’s health, as does the agency’s endorsement of over-the-counter sales of powerful contraceptives without a physician’s recommendation. We support cutting federal and state funding for entities that endanger women’s health by performing abortions in a manner inconsistent with federal or state law.

Studies, however, have overwhelmingly found mifepristone to be safe. In fact, the Association of Reproductive Health Professionals says mifepristone “is safer than acetaminophen,” aspirin, and Viagra. When the FDA conducted a 2011 post-market study of those who have used the drug since it was approved by the agency, they found that more than 1.5 million women in the U.S. had used it to end a pregnancy, only 2,200 of whom had experienced an “adverse event” after.

The platform also appears to reference the FDA’s approval of making emergency contraception such as Plan B available over the counter, claiming that it too is a threat to women’s health. However, studies show that emergency contraception is safe and effective at preventing pregnancy. According to the World Health Organization, side effects are “uncommon and generally mild.”

News Law and Policy

Supreme Court Rejects Challenge to Washington Law Requiring Pharmacies to Stock Plan B

Jessica Mason Pieklo

On Tuesday the Roberts Court turned away a challenge by a pharmacy-owning family who claimed a Washington state law that requires pharmacies to stock Plan B or other emergency contraception violated their religious beliefs.

The Supreme Court on Tuesday refused to hear a challenge by a pharmacy owner who claimed religious objections to a Washington law requiring pharmacies to stock and dispense Plan B or other emergency contraception.

In 2007, the Washington State Board of Pharmacy adopted rules governing the mandatory stocking and delivery of emergency contraception. The rules do not require any individual pharmacist to dispense medication in conflict with their religious beliefs. Instead, if a pharmacy employs a pharmacist who objects to dispensing emergency contraception for religious reasons, the pharmacy must keep on duty at all times a second pharmacist who does not object to dispensing those drugs.

The Stormans family—who own a local grocery store and pharmacy in Olympia, Washington—challenged the rules in 2012, arguing that the rules required them to violate their religious beliefs. Those beliefs, they said, include a conviction that life begins at conception; therefore, emergency contraception acts as an abortifacient, which they also object to providing.

The medical community does not consider emergency contraception to be an abortifacient.

A district court agreed with the Stormans that the rules could force them to violate their religious beliefs by stocking the medication. But in 2015, the U.S. Court of Appeals for the Ninth Circuit reversed and rejected the Stormans’ claim.

On Tuesday the Supreme Court let stand that Ninth Circuit ruling. However, Chief Justice John Roberts and Justices Samuel Alito and Clarence Thomas dissented from that decision. Writing for the dissenting justices, Alito called the case “an ominous sign” for religious liberties protections in the country.

“There are strong reasons to doubt whether the regulations were adopted for—or that they actually serve—any legitimate purpose,” wrote Alito. “And there is much evidence that the impetus for the adoption of the regulations was hostility to pharmacists whose religious beliefs regarding abortion and contraception are out of step with prevailing opinion in the State. Yet the Ninth Circuit held that the regulations do not violate the First Amendment, and this Court does not deem the case worthy of our time,” continued Alito.

“If this is a sign of how religious liberty claims will be treated in the years ahead, those who value religious freedom have cause for great concern,” he continued.

American Civil Liberties Union Deputy Legal Director Louise Melling disagreed with Justice Alito’s assessment of the case. “The court properly refused to take this case,” Melling said in a statement following the order. “When a woman walks into a pharmacy, she should not fear being turned away because of the religious beliefs of the owner or the person behind the counter. Open for business means opens for all,” said Melling.

“Refusing someone service because of who they are—whether a woman seeking birth control, a gay couple visiting a wedding catering company, or an unwed mother entering a homeless shelter—amounts to discrimination, plain and simple. Religious freedom is a core American value and one that we defend, but religious freedom does not mean a free pass to impose those beliefs on others,” Melling wrote.

Meanwhile, Alliance Defending Freedom Senior Counsel Kristen Waggoner, who represented the plaintiffs in the case, expressed disappointment in the decision. “All Americans should be free to peacefully live and work consistent with their faith without fear of unjust punishment, and no one should be forced to participate in the taking of human life,” said Waggoner in a statement after the denial. “We had hoped that the U.S. Supreme Court would take this opportunity to reaffirm these long-held principles.”

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