FDA advisory panel backs over-the-counter birth control pill

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In a unanimous vote, norgestrel (Opill; HRA Pharma) has been backed by an FDA advisory panel as an over-the-counter birth control pill.

FDA advisory panel backs over-the-counter birth control pill | Image Credit: © JHVEPhoto - © JHVEPhoto - stock.adobe.com.

FDA advisory panel backs over-the-counter birth control pill | Image Credit: © JHVEPhoto - © JHVEPhoto - stock.adobe.com.

The first over-the-counter (OTC) birth control pill has been backed by a panel of advisors to the FDA in a unanimous vote of 17 individuals.1,2

The prescription-free pill, norgestrel (Opill; HRA Pharma) is a progestin-only pill (POP) which prevents pregnancy by administering a synthetic version of the hormone progesterone. Unlike most pills, norgestrel does not contain estrogen.

Panel members explained their reasons for backing the pill after the vote. Deborah Armstrong, MD, professor of oncology, gynecology, and obstetrics at Johns Hopkins, stated the risk of unintended pregnancy is lower with the pill than with any alternative method of contraception available to women without seeking aid from a health care provider.

Armstrong also expressed a belief that patients would recognize if they had health conditions incompatible with the pill.

"I voted yes because the evidence demonstrates that the benefits clearly exceed the risks," said Kathryn Curtis, a health scientist with the CDC’s division of reproductive health. Access to effective birth control, increased reproductive autonomy, and reductions in unintended pregnancies and associated risks are all benefits the pill offers.

HRA Pharma initially submitted norgestrel to the FDA in July 2022.3 In 1973, the FDA approved norgestrel as a prescription option for preventing pregnancy. When submitting the application for an Rx-to-OTC switch, the manufacturer stated it would remove hurdles to accessing the pill and improve access to contraception.

The application was also supported by the American College of Obstetricians and Gynecologists, the American Medical Association, and the American Academy of Family Physicians. Investigators have estimated the rate of unintended pregnancies would be reduced by 81% through solely using an OTC POP.4

“It may surprise some clinicians that even with the most conservative model inputs, there is still a demonstrated benefit of a reduced number of unintended pregnancies with the use of an OTC POP, compared to what women currently use,” said Helene Guillard, PharmD, global Rx-to-OTC switch director at HRA Pharma.

“Clinicians also need to realize that 90% of the pregnancies prevented by the use of an OTC POP in the model occurred among women previously using either no contraception or one of the least effective methods,” Guillard added.

Reference

1. Hensley S, Stein R. Advisers to the FDA back first over-the-counter birth control pill. National Public Radio. May 10, 2023. Accessed May 10, 2023. https://www.npr.org/sections/health-shots/2023/05/10/1175255611/advisers-to-the-fda-back-over-the-counter-birth-control-pill

2. US Food and Drug Administration. 2023, May 10.May 9-10, 2023 Joint Meeting of the NDAC and the ORUDAC - Day 2. Video. YouTube. https://www.youtube.com/watch?v=LO65CZ_PDeM

3. Petronelli M. Application submitted to FDA for first-ever OTC birth control pill. Contemporary OB/GYN. July 11, 2022. Accessed May 10, 2022. https://www.contemporaryobgyn.net/view/application-submitted-to-fda-for-first-ever-otc-birth-control-pill

4. Kronemyer B. Preventing unintended pregnancies with an OTC progestin-only pill. Contemporary OB/GYN. November 8, 2022. Accessed May 10, 2022. https://www.contemporaryobgyn.net/view/preventing-unintended-pregnancies-with-an-otc-progestin-only-pill

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