FDA changes Plan B label to remove warning that it may cause abortion

pill, plan b

The Plan B One-Step emergency contraception label has been overhauled by the U.S. Food and Drug Administration (FDA), which has removed a warning disclosing that the emergency contraception aimed at preventing ovulation may secondarily function as an abortifacient.

The move comes just months after the Supreme Court overturned Roe v. Wade, allowing states to pass laws protecting preborn children from abortion, though Plan B first requested the change nearly a decade ago. Plan B has been available over the counter since 2013, and as early as 2014, Plan B requested that the FDA alter the label to state that it does not prevent the implantation of a newly formed human being — despite evidence that it has the potential to do so.

According to the FDA‘s new label, the drug used in Plan B — levonorgestrel (LNG) — “does not terminate an established pregnancy and does not affect a continuing pregnancy.” The government agency stated that it “determined the current science supports a conclusion that Plan B One-Step works by inhibiting or delaying ovulation and the mid-cycle hormonal changes.” It concluded, “In summary, LNG-EC is shown to act primarily by interfering with ovulation (delay or inhibition of follicle rupture and/or the midcycle LH and related hormonal changes) and not to act through direct effect on fertilization or on the endometrium to impede implantation.”

It noted, “The evidence also supports the conclusion that there is no direct effect on fertilization or implantation.”

But questions remain.

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Board-certified OB/GYN Dr. Donna Harrison, executive director of the American Association of Pro-Life Obstetricians and Gynecologists explained back in 2014 how Plan B could function as an abortifacient (cause the death of an embryo). In a 2014 piece for the National Review, she said:

When ovulation does occur after [Plan B] has been given, most of those ovulations show luteal-phase defect (see hereherehereherehere, and here).

That’s the term for when the ovary does not produce enough progesterone to allow the embryo to survive. If the LH surge is blunted […] then the ovary will release the egg, which can be fertilized but not produce enough progesterone […]. So, the embryo formed would not survive long enough to produce a positive pregnancy test. And interference with the LH surge is precisely how Plan B works.

If Plan B is taken five to two days before egg release is due to happen, the interference with the LH signal prevents a woman from releasing an egg, no fertilization happens, and no embryo is formed. Current studies do not demonstrate a harmful effect on the embryo if Plan B is taken after egg release.

Many authors focus on these two facts to make the sweeping claim that Plan B has no effect on a human embryo. What they are forgetting is Plan B’s effect [during…] the two-day window in which embryos can form but positive pregnancy tests don’t occur. That’s the window during which the studies mentioned above suggest that Plan B has a likely embryocidal effect in stopping pregnancy.

The luteal-phase occurs after ovulation — which is triggered by the luteinizing hormone (LH) — but before menstruation. The hormone progesterone is released at this time to thicken the uterine lining in preparation for implantation. According to the Fertility Center of San Antonio, a luteal-phase defect inhibits the growth of the uterine lining, which is required for embryo implantation and fetal development. It’s responsible for repeat early miscarriages, according to Ava Women. According to Dr. Harrison, when Plan B is taken and ovulation does occur, it can cause a luteal-phase defect and therefore prevent the thickening of the uterine lining that is necessary for the newly formed human being to survive.

Studies have shown that all forms of emergency contraception, including Plan B, can function as abortifacients. According to the Charlotte Lozier Institute’s assessment of the studies, “All point to Plan B’s having a predominantly post-fertilization (abortifacient) MOA [mechanisms of action] when it is given during a woman’s fertile period.”

Interestingly, as some retailers put caps on how many boxes of Plan B can be ordered at once, the FDA ensured Plan B customers that the fall of Roe will have no impact on access to the emergency contraception. “Plan B is not in any way connected to Roe v Wade,” stated the FDA. “Plan B will continue to be made available at all major retailers without a prescription, ID or age restriction regardless of any rulings on abortion restrictions.

“Foundation Consumer Healthcare [owner of Plan B] will continue to advocate that no legal barriers should limit a woman’s access to Plan B emergency contraception.”

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