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Updated: Jul 11, 2025

Reproductive Techniques for Ovarian Monitoring and Control in Amphibians

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Published on: May 12, 2019

Opill: The Over-the-Counter Contraceptive Pill.

Rebecca H Allen¹, Deborah Bartz

¹Warren Alpert Medical School of Brown University, Providence, Rhode Island; and Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

Obstetrics and Gynecology

|November 9, 2023

Summary

The U.S. Food and Drug Administration approved the first daily progestin-only oral contraceptive pill (OCP) for over-the-counter access. This advancement aims to improve contraceptive accessibility, particularly for marginalized populations, by removing prescription barriers.

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Published on: November 11, 2022

Area of Science:

Reproductive Health
Pharmacology
Public Health Policy

Background:

Prescription requirements for oral contraceptive pills (OCPs) limit access for many individuals.
Improved access to contraception is crucial for public health and reproductive autonomy.
Over-the-counter (OTC) availability can address healthcare disparities.

Purpose of the Study:

To announce and discuss the FDA approval of the first OTC progestin-only oral contraceptive pill.
To highlight the potential impact of this approval on contraceptive accessibility and unintended pregnancy rates.
To examine the safety profile and contraindications of the newly approved OTC OCP.

Main Methods:

Review of the FDA approval process for the norgestrel 0.075 mg progestin-only pill.
Analysis of the pill's safety profile, including contraindications.
Evaluation of the Pearl Index as a measure of contraceptive efficacy (estimated at 4.4).

Main Results:

The U.S. Food and Drug Administration approved the first OTC oral contraceptive pill (norgestrel 0.075 mg daily).
The progestin-only pill demonstrates an excellent safety profile with minimal contraindications.
The estimated Pearl Index is 4.4, indicating contraceptive effectiveness.

Conclusions:

The OTC availability of this OCP represents a significant advancement in reproductive healthcare accessibility.
This approval has the potential to reduce unintended pregnancies, especially among underserved and marginalized populations.
Successful implementation hinges on availability, affordability, and addressing potential barriers in diverse communities.