The FDA said it made the change now because it had completed a review of a 2018 application to change the label filed by Foundation Consumer Healthcare, a company that bought the Plan B brand from Teva Pharmaceutical Industries in 2017. Agency officials said the pandemic has delayed the review process and the timing was not dictated by political considerations.
A spokeswoman for the company, Dani Hirsch, said in an interview that for its 2018 filing, the company had not conducted any new studies, but submitted “whatever was already there.”
In a statement, the company’s director of marketing, Tara Evans, said that “the misconception that plan B works by interfering with implantation may be a barrier to wider access to emergency contraception. The Plan B labeling correction helps protect continued access to over-the-counter emergency contraception and reduce confusion about how Plan B works and further clarify that Plan B does not affect implantation.
Plan B One-Step and its generic versions — including brands like Take Action, My Way, and Option 2 — contain levonorgestrel, a class of hormones called progestins that are also found in lower doses in birth control pills and IUDs. The pills are most effective at preventing pregnancy if taken within 72 hours of intercourse, although they can sometimes work if taken within five days.
Another type of morning-after pill, marketed as Ella that contains a substance called ulipristal acetate, is available by prescription only and is not affected by the FDA’s label change. Less research has been done on this type of pill, but studies suggest it is highly unlikely to prevent implantation of a fertilized egg. In 2009, after months of research, Ella was approved for sale in predominantly Catholic Italy, where laws would have banned it if it had been considered to cause abortions.
According to data published in 2021 by the Centers for Disease Control and Prevention, nearly a quarter of women of childbearing age who have sex with men answered yes to the question, “Have you ever used emergency contraception, also known as ‘Plan B, ‘Preven’, ‘Ella’, ‘Next Choice’ or ‘Morning after’ pills?” The agency did not break down the data by the type of pills taken.
Back in the 1999 approval process, the maker of Plan B — Barr Pharmaceuticals, later acquired by Teva — asked the FDA not to list an implantation effect on the label, The Times reported in 2012.