Inaccurate language—which resulted from a 2006 compromise between anti-abortion activists and the FDA—has been removed from emergency contraceptive Plan B.
The U.S. Food and Drug Administration (FDA) has finally changed the labeling of the emergency contraceptive Plan B One-Step, removing an inaccurate statement that the medication may function by blocking a fertilized egg from implanting in the womb. Reproductive health advocates have for years called on the FDA to remove the incorrect language, which has fueled anti-abortion claims that emergency contraception causes abortion.
“We are very glad that the FDA acknowledged the very solid science that exists and has existed for several years,” said Kelly Cleland, executive director of the American Society for Emergency Contraception. “I hope this will help to bolster access to emergency contraception and remove some of the barriers to use and access.”
Plan B One-Step’s “drug facts” label has since 2006 stated that the pill might prevent “attachment of a fertilized egg to the uterus.” Numerous studies since then have shown that Plan B does not prevent implantation of a fertilized egg or in any way harm an existing pregnancy, according to the American College of Obstetricians and Gynecologists. Instead, the medication works by delaying ovulation and preventing sperm from fertilizing an egg.
In FAQs on their website, the FDA clearly states that Plan B One-Step does not cause abortion: “Plan B One-Step will not work if a person is already pregnant, meaning it will not affect an existing pregnancy. Plan B One-Step prevents pregnancy by acting on ovulation, which occurs well before implantation. Evidence does not support that the drug affects implantation or maintenance of a pregnancy after implantation, therefore it does not terminate a pregnancy.”
Research shows that close to one-quarter of heterosexually-active, reproductive-age women have used emergency contraception. Increased access to emergency contraception has contributed to decreasing abortion rates.
The inaccurate language resulted from a compromise with anti-abortion science advisers to the FDA when the medication was approved for over-the-counter-sales in 2006. Anti-abortion advocates, who claim that “life” begins at the moment of fertilization, have used the FDA label to justify their belief that emergency contraception causes abortion.
“Even if Plan B prevented implantation, it still wouldn’t be an abortifacient because there’s no pregnancy,” said Cleland, who notes the consensus of medical professionals defining pregnancy as beginning at implantation of a fertilized egg in the uterus, which occurs six to 12 days after fertilization.
“Now, with this language removed, we can very clearly say that Plan B does not interrupt pregnancy, no matter how you define it. That’s helpful,” said Cleland.
The FDA correction is critical because of widespread misunderstanding of how emergency contraception functions, which may discourage its use. A 2021 study found that over 60 percent of 1,443 people surveyed believed that emergency contraception works by preventing the implantation of a fertilized egg.
“The label has been used to create confusion and barriers to access,” said Cleland. “Having this clarified will help take away all of that ambiguity so people can know this is a contraceptive.”
The anti-abortion movement has for years tried to conflate emergency contraception and the abortion pill mifepristone, which are completely different medications that function entirely differently. Emergency contraception prevents pregnancy and does not affect an ongoing pregnancy. Mifepristone ends a pregnancy.
Plan B contains the hormone levonorgestrel — a progestin — which can prevent ovulation and block fertilization when taken within 72 hours after unprotected sex. The abortion pill mifepristone functions by blocking the pregnancy-sustaining hormone progesterone.
The label change applies only to Plan B and similar generic progestin-based emergency contraceptive, but does not apply to ella, a form of EC that contains ulipristal acetate and is only available by prescription. Studies suggest ella also does not prevent implantation of a fertilized egg. Ella is more effective than Plan B, especially for people weighing over 165 pounds.
The FDA label correction is important because anti-abortion advocates and lawmakers have used the claim that emergency contraception causes abortion to refuse to justify restrictions on the medication.
Nine states refuse to cover emergency contraception in government family planning programs and contraception coverage mandates. Six states allow pharmacists to refuse to dispense emergency contraception. Pennsylvania allows hospitals to refuse to provide emergency contraception to sexual assault survivors.
After the Obama administration instituted a contraceptive mandate under the Affordable Care Act in 2012, conservative groups fought for years to win religious exemptions from having to cover emergency contraception in their health insurance plans. In the 2014 ruling in Burwell v. Hobby Lobby Stores, the Supreme Court actually cited the FDA’s webpage about Plan B to support Hobby Lobby’s religious objection claim. Similar misunderstandings underlay the Trump administration’s 2017 moral and religious exemptions to the contraception mandate and the 2020 Supreme Court case of Little Sisters of the Poor v. Pennsylvania.
In floor debates in June of 2021 about a bill to require the Department of Veterans Affairs to cover the cost of all forms of contraception, including emergency contraception, U.S. Rep. Marjorie Taylor Greene (R-Ga.) incorrectly stated, “The Plan B pill kills a baby in the womb once a woman is already pregnant.”
Since the Supreme Court has overturned Roe v. Wade, reproductive rights advocates fear that lawmakers in red states will now try to ban emergency contraception or even hormonal contraception more generally.
“The label change is important because they can no longer cite the FDA as the authoritative source to support this position,” said Cleland.
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