Judge Edward Korman tonight approved the Obama Administration’s plan to make emergency contraception (EC) available over the counter, a necessary step required by the court in the ongoing saga to make a simple, effective, and safe method of contraception accessible to all who need it. But he did not conceal his frustration with the administration’s approach to complying with his order.
In his original order, Judge Korman instructed the administration to make two-pill levornogestrel products available over-the-counter. The administration responded with a plan to make Plan B One-Step (PBOS), the brand-name one-pill form of emergency contraception manufactured by Teva Corporation, available instead.
In a letter to Judge Korman protesting the administration’s plan prior to its approval, the Center for Reproductive Rights noted several problems with the administration’s plan. First, in making only PBOS available over-the-counter, the administration was actually ignoring the Judge’s order focusing on making two-pill levornogestrel available without point-of-sale or age restrictions. In doing so, the administration also failed to provide evidence requested by the Judge as to “significant differences” in data between the safety or usage of one- and two-pill versions of EC. Indeed, neither the Department of Justice or the FDA offered any such evidence.
Second, making PBOS available OTC requires a change in labeling by the FDA, something for which the administration failed to provide a definitive timeline. And third, PBOS is far more expensive than generic forms of two-pill emergency contraception, meaning that an extremely time-sensitive contraceptive method for which it will be difficult to obtain insurance coverage will cost upwards of $50.00 over the counter, a cost barrier many teens and low-income women will find difficult to overcome. Judge Korman clearly recognized these problems. “The real problem relating to cost deals
with the potential period of marketing exclusivity that the FDA may grant to Teva [in making PBOS available],” the Judge wrote in his latest order. “Specifically, the defendants’ letter states that, “[i]f FDA grants Teva marketing exclusivity, the scope of that exclusivity may affect the labeling that could be approved for generic equivalents of [Plan BOne-Step].” He then stated that the administration’s course of action “obfuscates the true effect of the FDA’s grant of marketing exclusivity to Teva,” and confers “a near-monopoly that will only result in making a one-pill emergency contraceptive more expensive and thus less accessible to many poor women.”
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It is only because of the extraordinary efforts by the plaintiffs in pursuing their Citizen Petition that Teva is able to seek approval of an SNDA that will permit it to market its product with no point-of-sale or age restriction. Such approval, if given, will be nothing more than a reward to Teva for playing along with the defendants’ efforts to maintain their legally and scientifically unjustified restrictions on the marketing of levonorgestrel-based emergency contraceptives. It is the plaintiffs, rather than Teva, who are responsible for the outcome of this case, and it is they, and the women who benefitted from their efforts, who deserve to be rewarded.
The bottom line is that before Plan B One-Step is widely available, the FDA must go through a re-labeling process, which it has said will happen “without delay.” That promise, however, comes from an agency within an administration that has played politics with EC now for several years. And even once the labeling process is over, making EC accessible in the truest sense means that the administration will need to act to work assiduously to counter all the confusion on EC (in the public, among pharmacists and salespeople) to which it has contributed and act expeditiously to make generic forms of the method available.
Nancy Northup, president and CEO of the Center for Reproductive Rights, which has led the fight for emergency contraception for years, stated “We are tremendously gratified that this lawsuit has resulted in a historic victory to bring emergency contraception out from behind the pharmacy counter for millions of women across the United States. We agree with Judge Korman that women deserve the full range of available emergency contraception, including lower cost generic options. [And] we will continue our advocacy on all fronts to ensure widespread availability of affordable birth control for all women in the United States and beyond.”
In short, women’s rights groups will keep watching. The ongoing effort to ensure accountability of an ostensibly pro-choice administration’s commitment to public health and evidence-based policy is probably not where many such groups expected to be spending their time.
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 theNew 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 equality; declaring 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 Rewireexplained 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.
Pressure is mounting on Congress to send President Obama a sufficient spending bill to combat the Zika virus’ spread.
The House and Senate recently passed their own measures, both proposing less than the $1.9 billion the president requested. But now they must work out their differences for the sake of our public health. Currently, none of these proposals include funding for Title X, the federal program that provides low-income people with family planning services, birth control, and other preventive reproductive health services. With the potentially life-changing outcomes that can result from contracting Zika, federal and state action is urgently needed to support prevention efforts and increase access to the full range of contraception available nationwide.
There’s no time to waste. More than 600 people in the continental United States, including at least 150 pregnant women, have already been infected with Zika. This month, a New Jersey infant exposed to Zika was born with the birth defect microcephaly, where a baby’s head is smaller than expected. Many more Americans have been affected in Puerto Rico and other U.S. territories. Local transmission is expected to spike as warmer weather approaches and climate conditions become more favorable to the virus’s primary vector, the Aedes aegypti mosquito.
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The Centers for Disease Control and Prevention (CDC) have reported significant evidence showing links between Zika and adverse pregnancy and birth outcomes, including miscarriage, stillbirth, and fetal abnormalities. Brain damage in Zika-infected babies is proving to be far worse than doctors initially thought. Zika has been found to attack lobes of the fetal brain that control thought, vision, and movement. Exposure to Zika was first considered to be a threat for women in the first trimester only, but there is growing concern about the possibility of maternal-fetal transmission throughout pregnancy.
It has also been discovered that men infected with Zika can transmit the virus to their sexual partners through semen, where the virus is stored much longer than in the blood.
As more individuals learn about the potential health risks linked to the virus, many will want and need services and information to help them effectively avoid or postpone pregnancy. Extensive research already shows the public health value and taxpayer savings associated with preventing unintended pregnancy.
Now with Zika, the stakes are even higher.
Congressional leaders must act without delay to pass a comprehensive Zika funding and preparedness package that includes additional resources for Title X to expand access to reliable birth control, related services, and counseling to low-income and uninsured people. Increased funding for these essential services is needed on the ground now, especially in regions expected to be disproportionately affected by the virus. The threat is particularly worrisome in areas that experience the warmer weather that’s conducive to Zika-carrying mosquitoes.
On the state level, elected leaders across the country should require public and commercial health plans to cover all—not just some—FDA-approved birth control. After the passage of the Affordable Care Act (ACA), California was one of the first states to approve a contraceptive-coverage equity law that codified the spirit of the ACA’s contraceptive mandate, also known as the birth control benefit, by requiring health plans to cover all methods of contraception without cost sharing or restrictions. Marylandrecently enacted a similar measure that also requires coverage for vasectomies, and several other states are considering legislation with the same intent. The Zika threat makes passage of these kinds of laws across the country time-sensitive. State Medicaid programs must also adopt reimbursement and coverage policies that break down barriers enrollees may face in accessing the full range of effective contraceptive methods.
Patientsmust be able to get the method they can use safely and consistently. That means health-care professionals across the country, including those in primary-care settings, must offer all forms of available birth control. Providers need training to support their patients in accessing the contraceptive method that is best suited for their health and reproductive life goals. Even some OB-GYNs can use training on newer methods and updated best practices.
Many unknowns remain regarding the Zika virus, which has quickly become one of the world’s greatest public health challenges. But a concerted and proactive response—that includes improved access to contraception—must be implemented before Zika becomes a national public health crisis here in the United States.