FDA updates Plan B product labelling, clarifies it is not an abortion pill

SAN ANSELMO, CA - APRIL 05: A package of Plan B contraceptive is displayed at Jack's Pharmacy on April 5, 2013 in San Anselmo, California. A federal judge in New York City has ordered the Food and Drug Adminstration to make Plan B contraceptive, also known as the morning after pill, available to younger teens without a perscription within 30 days. The judges ruling overturns a December 2011 decision by the FDA to restrict access to the contraceptive to any girl under 17 years of age. (Photo Illustration by Justin Sullivan/Getty Images)
A package of Plan B contraceptive is displayed at a pharmacy in California in 2013. (Photo Illustration by Justin Sullivan/Getty Images)

The Food and Drug Administration (FDA) on Friday announced it had approved a request by the makers of Plan B to update how information about the drug is presented.

Along with several changes, the agency also specified that Plan B does not cause abortions.

“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 a pregnancy after implantation, therefore it does not terminate a pregnancy,” said the FDA.

Levonorgestrel, better known under the brand name Plan B One-Step or colloquially as the morning-after pill, is an over-the-counter medication used to prevent the chance of pregnancy following unprotected sex or when contraceptive methods failed or were not used.

Plan B prevents pregnancies by temporarily delaying the release of an egg from an ovary, thus stopping an egg from becoming fertilized by a sperm. The drug works best when taken within three days of unprotected sex, with the manufacturer advising that it works better the sooner it is taken.

The pill does not work if someone is already pregnant and will not terminate a pregnancy.

The FDA also moved the explanation of how the morning-after pill works from the drug facts label to the consumer information leaflet included with the product, and removed wording from the description of how the drug works that the agency said was “not supported by scientific evidence.” Specifically, wording that suggested Plan B could have affected processes that occurred after ovulation was removed.

“The evidence also supports the conclusion that there is no direct effect on postovulatory processes, such as fertilization or implantation. Accordingly, FDA updated the mechanism of action information in the Consumer Information Leaflet, which included removing references to the mechanisms not supported by the best available scientific evidence (that is, effects on fertilization and implantation),” the agency said.

After the Supreme Court struck down Roe v. Wade earlier this year, reproductive rights activists feared that some state legislatures may go after contraceptives, as Supreme Court Justice Clarence Thomas suggested in his concurring opinion.

Some state politicians have indicated their desire to potentially block access to Plan B. Matthew DePerno, the Republican candidate for Michigan attorney general, received backlash after a recording was obtained of him comparing Plan B to fentanyl and further saying it should be banned.

In the recording obtained by Heartland Signal, a progressive reporting site, DePerno appeared to not know what Plan B is, though he later said in an interview that the conversation had been taken out of context.

“Life begins at conception, and is the Plan B pill being used at that time as a contraceptive, or is it being used to terminate a pregnancy?” DePerno later asked “That’s the kind of conversation we were having. I think that’s a difficult question to answer.”

The White House condemned DePerno’s initial remark, with press secretary Karine Jean-Pierre calling it “another extreme and backwards proposal from Republican officials that will strip women of their rights.”

Georgia Gov. Brian Kemp (R) was also heard in a recording earlier this year discussing the possibility of banning contraception, saying it depended on “where the legislators are.” When asked about the recording during a debate with Democratic Georgia gubernatorial candidate Stacey Abrams, he said he did not wish to push any new legislation on abortions or birth control.

Tags Brian Kemp Clarence Thomas Contraception emergency contraceptive fda FDA Food and Drug Administration morning after pill Plan B.

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