Commentary Contraception

Administration Again Fails on Over-the-Counter Emergency Contraception

Jodi Jacobson

The Obama administration's newest plan to make emergency contraception over-the-counter to some groups and not others only creates more confusion and a new set of barriers to access. I guess this administration would rather play Russian Roulette with teen pregnancy than make it easier to prevent.

Update: 8:59 pm, Wednesday, May 1. Tonight the Obama Administration announced it would appeal Judge Korman’s ruling that emergency contraception be made available over-the-counter for everyone, putting science and public health aside for political reasons that are difficult, at best, to discern. More to come.

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.

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.

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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:

For too long, this important backup birth control method has been kept out of reach. Immigrant women and aspiring citizens of all ages have been hit particularly hard, since they are less likely to have government-issued identification. Putting emergency contraception on store shelves is a step in the right direction, but this decision still means another unneeded barrier for many Latinas who need contraception. Latinas already face far too many barriers, like poverty, discrimination and language, which prevent Latinas from accessing care.

For Latinas in particular, expanded access to emergency contraception is critical for making the best decisions for our families and ourselves. It’s disappointing that the FDA decided to undermine the recent court victory for immigrant women and young Latinas by introducing more unnecessary obstacles to emergency contraception, which is safe and necessary.

In a press release, Nancy Northup, president and CEO of the Center for Reproductive Rights, also pointed to the barriers to access left unaddressed by the policy:

The FDA is under a federal court order that makes it crystal clear that emergency contraception must be made available over the counter, without restriction to women of all ages by next Monday.

Lowering the age restriction to 15 for over-the-counter access to Plan B One-Step may reduce delays for some young women—but it does nothing to address the significant barriers that far too many women of all ages will still find if they arrive at the drugstore without identification or after the pharmacy gates have been closed for the night or weekend.

These are daunting and sometimes insurmountable hoops women are forced to jump through in time-sensitive circumstances, and we will continue our battle in court to remove these arbitrary restrictions on emergency contraception for all women.

It seems these days that no matter the administration in power, ensuring women have access to basic reproductive health care remains fraught with bias and mismanagement. On one hand, after going to ridiculous lengths to placate the United States Conference of Catholic Bishops (USCCB) on something as basic as including coverage for contraception under health insurance, the administration is fighting the USCCB and others in court over a policy to which the litigants are not even subject because these religious groups so hate the idea of women accessing contraception they are willing to empty collection plates to pay for court battles. On the other, advocates are now fighting the same administration in court on access to EC. And meanwhile, many pharmacies and pharmacists refuse to stock or dispense EC, no matter what, claiming personal religious objections.

The only thing that is clear is that the last chapter of this fight has yet to be written. Janet Crepps, a senior counsel for the Center for Reproductive Rights, told NPR Tuesday night that absent a stay, “we will want to go back to court as quickly as possible and ask the judge to hold them in contempt.”

So teens of any age can now buy prescription-strength drugs such as cough syrup and cold medicine over-the-counter without a prescription, but still cannot buy without hassles and barriers a drug that has been found to be safer than a wide array of other OTC drugs, and which has a small window of usefulness. I guess this administration would rather play Russian Roulette with teen pregnancy than make it easier to prevent.

Roundups Sexual Health

This Week in Sex: The Sexually Transmitted Infections Edition

Martha Kempner

A new Zika case suggests the virus can be transmitted from an infected woman to a male partner. And, in other news, HPV-related cancers are on the rise, and an experimental chlamydia vaccine shows signs of promise.

This Week in Sex is a weekly summary of news and research related to sexual behavior, sexuality education, contraception, STIs, and more.

Zika May Have Been Sexually Transmitted From a Woman to Her Male Partner

A new case suggests that males may be infected with the Zika virus through unprotected sex with female partners. Researchers have known for a while that men can infect their partners through penetrative sexual intercourse, but this is the first suspected case of sexual transmission from a woman.

The case involves a New York City woman who is in her early 20s and traveled to a country with high rates of the mosquito-borne virus (her name and the specific country where she traveled have not been released). The woman, who experienced stomach cramps and a headache while waiting for her flight back to New York, reported one act of sexual intercourse without a condom the day she returned from her trip. The following day, her symptoms became worse and included fever, fatigue, a rash, and tingling in her hands and feet. Two days later, she visited her primary-care provider and tests confirmed she had the Zika virus.

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A few days after that (seven days after intercourse), her male partner, also in his 20s, began feeling similar symptoms. He had a rash, a fever, and also conjunctivitis (pink eye). He, too, was diagnosed with Zika. After meeting with him, public health officials in the New York City confirmed that he had not traveled out of the country nor had he been recently bit by a mosquito. This leaves sexual transmission from his partner as the most likely cause of his infection, though further tests are being done.

The Centers for Disease Control and Prevention (CDC)’s recommendations for preventing Zika have been based on the assumption that virus was spread from a male to a receptive partner. Therefore the recommendations had been that pregnant women whose male partners had traveled or lived in a place where Zika virus is spreading use condoms or abstain from sex during the pregnancy. For those couples for whom pregnancy is not an issue, the CDC recommended that men who had traveled to countries with Zika outbreaks and had symptoms of the virus, use condoms or abstain from sex for six months after their trip. It also suggested that men who traveled but don’t have symptoms use condoms for at least eight weeks.

Based on this case—the first to suggest female-to-male transmission—the CDC may extend these recommendations to couples in which a female traveled to a country with an outbreak.

More Signs of Gonorrhea’s Growing Antibiotic Resistance

Last week, the CDC released new data on gonorrhea and warned once again that the bacteria that causes this common sexually transmitted infection (STI) is becoming resistant to the antibiotics used to treat it.

There are about 350,000 cases of gonorrhea reported each year, but it is estimated that 800,000 cases really occur with many going undiagnosed and untreated. Once easily treatable with antibiotics, the bacteria Neisseria gonorrhoeae has steadily gained resistance to whole classes of antibiotics over the decades. By the 1980s, penicillin no longer worked to treat it, and in 2007 the CDC stopped recommending the use of fluoroquinolones. Now, cephalosporins are the only class of drugs that work. The recommended treatment involves a combination of ceftriaxone (an injectable cephalosporin) and azithromycin (an oral antibiotic).

Unfortunately, the data released last week—which comes from analysis of more than 5,000 samples of gonorrhea (called isolates) collected from STI clinics across the country—shows that the bacteria is developing resistance to these drugs as well. In fact, the percentage of gonorrhea isolates with decreased susceptibility to azithromycin increased more than 300 percent between 2013 and 2014 (from 0.6 percent to 2.5 percent).

Though no cases of treatment failure has been reported in the United States, this is a troubling sign of what may be coming. Dr. Gail Bolan, director of CDC’s Division of STD Prevention, said in a press release: “It is unclear how long the combination therapy of azithromycin and ceftriaxone will be effective if the increases in resistance persists. We need to push forward on multiple fronts to ensure we can continue offering successful treatment to those who need it.”

HPV-Related Cancers Up Despite Vaccine 

The CDC also released new data this month showing an increase in HPV-associated cancers between 2008 and 2012 compared with the previous five-year period. HPV or human papillomavirus is an extremely common sexually transmitted infection. In fact, HPV is so common that the CDC believes most sexually active adults will get it at some point in their lives. Many cases of HPV clear spontaneously with no medical intervention, but certain types of the virus cause cancer of the cervix, vulva, penis, anus, mouth, and neck.

The CDC’s new data suggests that an average of 38,793 HPV-associated cancers were diagnosed each year between 2008 and 2012. This is a 17 percent increase from about 33,000 each year between 2004 and 2008. This is a particularly unfortunate trend given that the newest available vaccine—Gardasil 9—can prevent the types of HPV most often linked to cancer. In fact, researchers estimated that the majority of cancers found in the recent data (about 28,000 each year) were caused by types of the virus that could be prevented by the vaccine.

Unfortunately, as Rewire has reported, the vaccine is often mired in controversy and far fewer young people have received it than get most other recommended vaccines. In 2014, only 40 percent of girls and 22 percent of boys ages 13 to 17 had received all three recommended doses of the vaccine. In comparison, nearly 80 percent of young people in this age group had received the vaccine that protects against meningitis.

In response to the newest data, Dr. Electra Paskett, co-director of the Cancer Control Research Program at the Ohio State University Comprehensive Cancer Center, told HealthDay:

In order to increase HPV vaccination rates, we must change the perception of the HPV vaccine from something that prevents a sexually transmitted disease to a vaccine that prevents cancer. Every parent should ask the question: If there was a vaccine I could give my child that would prevent them from developing six different cancers, would I give it to them? The answer would be a resounding yes—and we would have a dramatic decrease in HPV-related cancers across the globe.

Making Inroads Toward a Chlamydia Vaccine

An article published in the journal Vaccine shows that researchers have made progress with a new vaccine to prevent chlamydia. According to lead researcher David Bulir of the M. G. DeGroote Institute for Infectious Disease Research at Canada’s McMaster University, efforts to create a vaccine have been underway for decades, but this is the first formulation to show success.

In 2014, there were 1.4 million reported cases of chlamydia in the United States. While this bacterial infection can be easily treated with antibiotics, it often goes undiagnosed because many people show no symptoms. Untreated chlamydia can lead to pelvic inflammatory disease, which can leave scar tissue in the fallopian tubes or uterus and ultimately result in infertility.

The experimental vaccine was created by Canadian researchers who used pieces of the bacteria that causes chlamydia to form an antigen they called BD584. The hope was that the antigen could prompt the body’s immune system to fight the chlamydia bacteria if exposed to it.

Researchers gave BD584 to mice using a nasal spray, and then exposed them to chlamydia. The results were very promising. The mice who received the spray cleared the infection faster than the mice who did not. Moreover, the mice given the nasal spray were less likely to show symptoms of infection, such as bacterial shedding from the vagina or fluid blockages of the fallopian tubes.

There are many steps to go before this vaccine could become available. The researchers need to test it on other strains of the bacteria and in other animals before testing it in humans. And, of course, experience with the HPV vaccine shows that there’s work to be done to make sure people get vaccines that prevent STIs even after they’re invented. Nonetheless, a vaccine to prevent chlamydia would be a great victory in our ongoing fight against STIs and their health consequences, and we here at This Week in Sex are happy to end on a bit of a positive note.

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.”