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

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 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 U.S. Food and Drug Administration 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,” meaning that the egg is not yet fertilized, 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’s 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 change in wording comes soon after the U.S. Supreme Court overturned the historic Roe vs. Wade decision made in the 1970s, effectively rendering abortion illegal in many states.

Advocates for abortion rights have warned that, partially based on the former language included in morning after pill packaging, anti-abortion foes might seek to outlaw or restrict access to the pills.

Currently, some conservative states do allow pharmacies the right to refuse to carry pills such as Plan B. And one recent study found that more than 60% of the more than 1,400 people surveyed say they believed the pill worked by stopping the implantation of an already fertilized egg.

That is not the case, according to scientific research conducted over the past decade.

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 FDA’s ability to process the application until now, it said.

Speaking in a company statement, Foundation Consumer Healthcare’s 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.”

Teva Pharmaceutical Industries had previously requested that reference to implantation be deleted from Plan B’s labeling back in 2009 to 2010, the Times reported.

More information:

Find out more about the morning after pill at the FDA.

SOURCE: The New York Times

Source: HealthDay