FDA Updates Guidance on 'Morning After' Pill, Making Clear It Does Not Cause Abortions

New revised leaflets now clearly state that Plan B and its kin work 'before release of an egg from the ovary'

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TUESDAY, Dec. 27, 2022 (HealthDay News) -- On Friday, the U.S. Food and Drug Administration revised the language on "morning after" pills' packaging to make it clear that the pills are not abortion drugs.

For many years, Plan B One-Step and its generic equivalents -- collectively known as "morning after" pills to prevent a pregnancy -- included information in packaging that suggested that the pill might work by interrupting the implantation of a fertilized egg into the womb.

There was, however, no scientific evidence that was the case, experts have long contended. With the guidance in place, some anti-abortion activists made the erroneous claim that women who took the "morning after" pill were triggering an abortion.

Plan B was first approved in 1999 and can be obtained without a prescription. However, on Friday, the FDA removed language on implantation from the pills' packaging and instead added language that explicitly states that the pills are not abortion drugs, The New York Times reported.

New revised leaflets now clearly state that Plan B and its kin work "before release of an egg from the ovary," The Times reported. It goes on to say that the pill "will not work if you're already pregnant, and will not affect an existing pregnancy." And in a question-and-answer segment now posted on the FDA website, the question "Is Plan B One-Step able to cause an abortion?" is answered by "No," followed by "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 pregnancy after implantation; therefore, it does not terminate a pregnancy."

The FDA said its decision to change package labeling was not spurred by political considerations but was instead triggered by a review of a 2018 application from Foundation Consumer Healthcare, a company that bought the Plan B brand from Teva Pharmaceutical Industries in 2017. The pandemic delayed the ability of the FDA to process the application until now, it said.

Speaking in a company statement, Foundation Consumer Healthcare Marketing Director Tara Evans said "the misconception that Plan B works by interfering with implantation can present barriers to broader emergency contraception access. The Plan B labeling correction will help protect continued over-the-counter emergency contraception access and reduce confusion about how Plan B works and further clarify that Plan B does not affect implantation."

The New York Times Article

Physician’s Briefing Staff

Physician’s Briefing Staff

Published on December 27, 2022

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