EXECUTIVE SUMMARY
The United States may soon see its first over-the-counter (OTC) birth control pill. In June, HRA Pharma asked the FDA to grant OTC status to its oral contraceptive.
- The progestin-only daily birth control pill, marketed as Opill, has been available in the United States by prescription since 1973.
- The American Academy of Family Physicians, the American Medical Association, and the American College of Obstetricians and Gynecologists all support OTC access to hormonal contraception.
- An OTC contraceptive that is safe and effective will make birth control more accessible and help prevent unintended pregnancy, physicians and reproductive health advocates say.
The application for the first over-the-counter (OTC) birth control pill in the United States marks a new chapter in the ever-changing reproductive healthcare environment of 2022.
In June, Perrigo Company announced its HRA Pharma arm submitted an application to the FDA to approve its progestin-only daily birth control pill, Opill, for OTC status.1
The idea of providing an OTC birth control pill has been in the works for a while, and it is a positive prospect, says Jennifer Amico, MD, MPH, associate professor in the department of family medicine and community health at Rutgers Robert Wood Johnson Medical School in New Brunswick, NJ.
“We know birth control pills are very safe, and anything that improves access is a good thing,” Amico says.
Potential health problems are not a concern. “People have the ability to overdose on Tylenol,” Amico adds. “There are way more dangerous things that are over the counter.”
OTC birth control is long overdue, says Antonia Biggs, PhD, an associate professor and social psychologist in the department of obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco.
“People in other countries have been accessing contraceptives over the counter. It’s very safe medication,” says Biggs, a senior researcher with Advancing New Standards in Reproductive Health. “There’s no reason for it not to be OTC, except for the political nature of reproductive health, which should be treated as healthcare.”
National medical associations have expressed support for OTC birth control in recent years. For example, the American College of Obstetricians and Gynecologists (ACOG) supports OTC access to hormonal contraception without age restrictions.2
“Over-the-counter access has continuation rates of hormonal contraception comparable to prescription-only access and has the potential to decrease unintended pregnancy,” ACOG concluded.
The American Academy of Family Physicians (AAFP) also has published its support of OTC access to oral contraception without a prescription. The AAFP supports insurance coverage of oral contraception in all insurance plans.3
On June 15, the American Medical Association (AMA) issued a statement supporting removing the prescription barrier to contraception and encourages the FDA to approve OTC access to oral contraceptives without an age restriction.4
“Providing patients with OTC access to the birth control pill is an easy call from a public health perspective as the health risks of pregnancy vastly outweigh those of oral contraceptive use,” noted AMA board member David H. Aizuss, MD. “Access is one of the most cited reasons why patients do not use oral contraceptives, use them inconsistently, or discontinue use. Expanding OTC access would make it easier for patients to properly use oral contraceptives, leading to fewer unplanned pregnancies.”
In 2017, the AMA adopted a policy supporting equitable access to over-the-counter contraception.5
Opill has been used to prevent pregnancy in the United States since 1973. Five decades of data show it is both effective and safe, according to HRA Pharma.1
Granting this birth control pill OTC status will help women who are unable to access contraception because of cost, time, distance from clinics, and other obstacles. “As a doctor, I am dedicated to empowering people to make decisions about pregnancy prevention,” says Melissa J. Kottke, MD, MPH, MBA. “For many, a birth control pill may be the best option for them, but requiring a prescription is an unnecessary obstacle that can put it out of reach. Removing the prescription requirement for a progestin-only birth control pill will be a historic advancement for pregnancy prevention and a remarkable achievement in community public health.”1
Advocates for Youth issued a statement on HRA Pharma’s application, saying young people have been working for an OTC birth control pill through the #FreethePill youth council.6
“Now more than ever, young people need birth control that’s accessible, affordable, and over-the-counter,” says Angela Maske, strategic projects manager and coordinator of the #FreethePill youth council. “We need tools to help us plan our lives and our futures. And we need policies that move us forward, not backward.” The application could be approved as soon as the first half of 2023.7
“Oral contraceptives are extremely popular and safe. If they are over the counter, that will eliminate some access barriers,” says Julia Strasser, DrPH, assistant research professor in health policy and management at the Milken Institute School of Public Health at George Washington University. “But no matter how much contraceptive access there is, it can never replace what is lost because of abortion access barriers.”
REFERENCES
- HRA Pharma. Perrigo’s HRA Pharma submits application to FDA for first-ever OTC birth control pill. July 11, 2022.
- American College of Obstetricians and Gynecologists. Over-the-counter access to hormonal contraception: ACOG Committee Opinion, number 788. Obstet Gynecol 2019;134:e96-e105.
- American Academy of Family Physicians. Over-the-counter oral contraceptives.
- American Medical Association. AMA urges FDA to make oral contraceptive available over-the-counter. June 15, 2022.
- American Medical Association. Over-the-counter contraceptive drug access (Resolution 110-A-17). AMA Report to the Board of Trustees. 2018.
- Advocates for Youth. Statement on HRA Pharma’s application for OTC status for birth control. July 11, 2022.
- Leo L, Eluri KC, Ganguli S. FDA to review first ever over-the-counter birth control pill. Reuters. July 12, 2022.
The application for the first OTC birth control pill in the United States marks a new chapter in the ever-changing reproductive healthcare environment of 2022. In June, Perrigo Company announced its HRA Pharma arm submitted an application to the FDA to approve its progestin-only daily birth control pill, Opill, for OTC status.
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