News Law and Policy

Obama Administration Throws Science and Public Health Out the Window in Appeal of Plan B Ruling

Jessica Mason Pieklo

The Obama administration announced it was appealing a federal court order that lifted age-restrictions on the sale of emergency contraception.

Just one day after the Food and Drug Administration (FDA) announced it would allow one brand of emergency contraception to be sold over-the-counter and without a prescription to people ages 15 and up, the Obama administration capitulated further to anti-choice conservatives and appealed a lower court ruling directing the agency to make emergency contraception available over-the-counter and without prescription to anyone who needs it, regardless of age.

On April 5, U.S. District Court Judge Edward Korman ordered the FDA to make levonorgestrel-based emergency contraception available without a prescription and without point-of-sale or age restrictions within 30 days. The ruling, a significant victory for science-supported public health policy, was in response to the Center for Reproductive Rights’ renewed lawsuit against the agency to expand over-the-counter access to the morning-after pill to women of all ages. In his 59-page decision, Judge Korman specifically called out the government’s stalling tactics, noting the “FDA has engaged in intolerable delays” amounting to an “administration agency filibuster” that plainly put politics before science.

The Obama administration has also asked Judge Korman to stay his April court order pending the outcome of the appeal.

Nancy Northup, president and CEO at the Center for Reproductive Rights, said in a statement:

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Women who urgently need emergency contraception have been delayed in getting it or denied access entirely for more than a decade because of the political maneuverings of the last two presidential administrations.

The federal court has made clear that these stalling tactics were based purely on politics, not science.

We are deeply disappointed that just days after President Obama proclaimed his commitment to women’s reproductive rights, his administration has decided once again to deprive women of their right to obtain emergency contraception without unjustified and burdensome restrictions.

The appeal will not affect the FDA’s decision on Plan B but instead will likely address the broader issue of whether the agency acted arbitrarily and capriciously in setting the age restrictions to begin with and could challenge the precedent of a federal judge striking down an order by Department of Health and Human Services Secretary Kathleen Sebelius, a sitting White House cabinet member. With the administration in the end stages of negotiating a final compromise on the contraception benefit in Obamacare, the decision to appeal the emergency contraception ruling could have as much to do with the contraception benefit as the FDA.

It’s also unclear what, if any, explanation the administration can offer in its decision to advocate for limiting access to emergency contraception, beyond the belief—expressed by the president but wholly unsupported by science—that individuals younger than 15 would be potentially harmed by having access to it. And while administrative agencies like the FDA have broad rule-making authority, Judge Korman, a conservative judge, decimated the administration’s purported concerns in a scathing opinion that detailed the politics and utter disregard for settled science exhibited by HHS in over-ruling the FDA’s original decision. The science is not on the administration’s side in this decision, and the politics shouldn’t be either.

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Commentary Contraception

Hillary Clinton Played a Critical Role in Making Emergency Contraception More Accessible

Susan Wood

Today, women are able to access emergency contraception, a safe, second-chance option for preventing unintended pregnancy in a timely manner without a prescription. Clinton helped make this happen, and I can tell the story from having watched it unfold.

In the midst of election-year talk and debates about political controversies, we often forget examples of candidates’ past leadership. But we must not overlook the ways in which Hillary Clinton demonstrated her commitment to women’s health before she became the Democratic presidential nominee. In early 2008, I wrote the following article for Rewirewhich has been lightly edited—from my perspective as a former official at the U.S. Food and Drug Administration (FDA) about the critical role that Clinton, then a senator, had played in making the emergency contraception method Plan B available over the counter. She demanded that reproductive health benefits and the best available science drive decisions at the FDA, not politics. She challenged the Bush administration and pushed the Democratic-controlled Senate to protect the FDA’s decision making from political interference in order to help women get access to EC.

Since that time, Plan B and other emergency contraception pills have become fully over the counter with no age or ID requirements. Despite all the controversy, women at risk of unintended pregnancy finally can get timely access to another method of contraception if they need it—such as in cases of condom failure or sexual assault. By 2010, according to National Center for Health Statistics data, 11 percent of all sexually experienced women ages 15 to 44 had ever used EC, compared with only 4 percent in 2002. Indeed, nearly one-quarter of all women ages 20 to 24 had used emergency contraception by 2010.

As I stated in 2008, “All those who benefited from this decision should know it may not have happened were it not for Hillary Clinton.”

Now, there are new emergency contraceptive pills (Ella) available by prescription, women have access to insurance coverage of contraception without cost-sharing, and there is progress in making some regular contraceptive pills available over the counter, without prescription. Yet extreme calls for defunding Planned Parenthood, the costs and lack of coverage of over-the-counter EC, and refusals by some pharmacies to stock emergency contraception clearly demonstrate that politicization of science and limits to our access to contraception remain a serious problem.

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Today, women are able to access emergency contraception, a safe, second chance option for preventing unintended pregnancy in a timely manner without a prescription. Sen. Hillary Clinton (D-NY) helped make this happen, and I can tell the story from having watched it unfold.

Although stories about reproductive health and politicization of science have made headlines recently, stories of how these problems are solved are less often told. On August 31, 2005 I resigned my position as assistant commissioner for women’s health at the Food and Drug Administration (FDA) because the agency was not allowed to make its decisions based on the science or in the best interests of the public’s health. While my resignation was widely covered by the media, it would have been a hollow gesture were there not leaders in Congress who stepped in and demanded more accountability from the FDA.

I have been working to improve health care for women and families in the United States for nearly 20 years. In 2000, I became the director of women’s health for the FDA. I was rather quietly doing my job when the debate began in 2003 over whether or not emergency contraception should be provided over the counter (OTC). As a scientist, I knew the facts showed that this medication, which can be used after a rape or other emergency situations, prevents an unwanted pregnancy. It does not cause an abortion, but can help prevent the need for one. But it only works if used within 72 hours, and sooner is even better. Since it is completely safe, and many women find it impossible to get a doctor’s appointment within two to three days, making emergency contraception available to women without a prescription was simply the right thing to do. As an FDA employee, I knew it should have been a routine approval within the agency.

Plan B emergency contraception is just like birth control pills—it is not the “abortion pill,” RU-486, and most people in the United States don’t think access to safe and effective contraception is controversial. Sadly, in Congress and in the White House, there are many people who do oppose birth control. And although this may surprise you, this false “controversy” not only has affected emergency contraception, but also caused the recent dramatic increase in the cost of birth control pills on college campuses, and limited family planning services across the country.  The reality is that having more options for contraception helps each of us make our own decisions in planning our families and preventing unwanted pregnancies. This is something we can all agree on.

Meanwhile, inside the walls of the FDA in 2003 and 2004, the Bush administration continued to throw roadblocks at efforts to approve emergency contraception over the counter. When this struggle became public, I was struck by the leadership that Hillary Clinton displayed. She used the tools of a U.S. senator and fought ardently to preserve the FDA’s independent scientific decision-making authority. Many other senators and congressmen agreed, but she was the one who took the lead, saying she simply wanted the FDA to be able to make decisions based on its public health mission and on the medical evidence.

When it became clear that FDA scientists would continue to be overruled for non-scientific reasons, I resigned in protest in late 2005. I was interviewed by news media for months and traveled around the country hoping that many would stand up and demand that FDA do its job properly. But, although it can help, all the media in the world can’t make Congress or a president do the right thing.

Sen. Clinton made the difference. The FDA suddenly announced it would approve emergency contraception for use without a prescription for women ages 18 and older—one day before FDA officials were to face a determined Sen. Clinton and her colleague Sen. Murray (D-WA) at a Senate hearing in 2006. No one was more surprised than I was. All those who benefited from this decision should know it may not have happened were it not for Hillary Clinton.

Sometimes these success stories get lost in the “horse-race stories” about political campaigns and the exposes of taxpayer-funded bridges to nowhere, and who said what to whom. This story of emergency contraception at the FDA is just one story of many. Sen. Clinton saw a problem that affected people’s lives. She then stood up to the challenge and worked to solve it.

The challenges we face in health care, our economy, global climate change, and issues of war and peace, need to be tackled with experience, skills and the commitment to using the best available science and evidence to make the best possible policy.  This will benefit us all.

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.”

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