Wording about fertilization and implantation will be removed from the Drug Facts label for Plan B One-Step and other emergency contraceptives, the U.S. Food and Drug Administration announced Friday.
According to the FDA, the applicant for Plan B One-Step requested the change. An administration review confirmed that over-the-counter medication has “no direct effect on fertilization or implantation.”
While the FDA did not directly mention the Dobbs v. Jackson Women’s Health Supreme Court decision that overturned Roe v. Wade reproductive rights protections in the U.S. this summer, there has been confusion about Plan B in the wake of the unpopular Dobbs opinion.
Shortly after the decision in June, The Wall Street Journal reported that Plan B pills were hard to find and getting pricier. The New York Times reported that people who began stocking up on emergency contraception medication after the Dobbs opinion leaked in May were concerned that the medication would be banned.
“In Dobbs v. Jackson, the Supreme Court held that emergency contraceptives like Plan B… are not affected by the court’s ruling that overturned the constitutional right to abortion – but ‘the ambiguity of the law’ and uncertainty around what it prohibits continues to cause confusion on whether Plan B can be legally accessed in certain states,” said Advisory Board.
Some states do have restrictions on access to emergency contraception, as outlined by the Guttmacher Institute.
According to the FDA, Plan B One-Step is a backup method of birth control not intended for regular use. An initial two-dose form of the medication was first approved by the FDA in 1999. A decade later, Plan B One-Step was approved, and in 2013 it was approved for nonprescription use without age restrictions.
In its current form, Plan B One-Step includes one levonorgestrel pill (1.5 mg) to be taken within 72 hours of intercourse. Levonorgestrel is a synthetic hormone that has been used in birth control pills for over 35 years, said the FDA. It works by stopping or delaying the release of an egg from the ovary and does not impact existing pregnancies.
“Plan B One-Step prevents pregnancy by acting on ovulation, which occurs well before implantation,” said the FDA. “Evidence does not support that the drug affects implantation or maintenance of a pregnancy after implantation, therefore it does not terminate a pregnancy.”
Although mechanism of action information is “rarely included” and not required in nonprescription drug labeling or the Drug Facts portion of labels, it was included for Plan B One-Step, the FDA explained. Therefore, after careful consideration the administration “determined that the most appropriate placement of mechanism of action information was primarily in the Consumer Information Leaflet rather than in the Drug Facts label,” going forward.
“Also, both the Drug Facts label and Consumer Information Leaflet retain statements that are consistent with the mechanism of action – that the product will not work if the woman is already pregnant,” said the FDA.
It said that there are 11 generics of Plan B One-Step. Labels for these medications are also expected to be updated.
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