The Issue at Hand: Over-The-Counter Authorization of Opill, an Oral Contraceptive
The FDA will be conducting a joint meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee on May 9 - 10, 2023. Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so.
At this meeting, the committees will discuss supplemental new drug application (sNDA) 017031/S-041, for OPILL (norgestrel) Tablet, 0.075 mg, submitted by Laboratoire HRA Pharma. OPILL is proposed for nonprescription (over the counter) use as a once daily oral contraceptive to prevent pregnancy.
As part of the pre-meeting preparation process, the FDA has opened this issue up to public comment. The National Women's Health Network submitted written testimony ahead of the meeting in support of making OPILL over-the-counter. Read our testimony in its entirety below, and get more information on the upcoming hearing here.
The NWHN’s Written Testimony to the FDA Regarding Over-The-Counter Authorization of Opill
April 24, 2023
Dr. Robert M. Califf
U.S. Food and Drug Administration
1903 New Hampshire Ave
Silver Spring, MD 20993-0002
Dear Administrator Califf:
The National Women’s Health Network is pleased that an advisory committee meeting has been scheduled to determine whether Opill, an oral contraceptive drug, meets the standard criteria for over the counter (OTC) medications. Decades of research support the safety and efficacy of oral contraception, and new advancements in telemonitoring technology provide patients with the option to self-manage their health and well-being comfortably in their own space. Switching the birth control pill to an over-the-counter medication will remove barriers to access and address issues relating to health equity and reproductive justice.
The National Women’s Health Network represents the health interests of women across the life continuum with intersectional focus on issues related to sexual and reproductive health, maternal health, and the health and well-being of aging women. We work to improve women’s health outcomes through state and federal advocacy, consumer health education, and grassroots technical assistance initiatives.
Birth control is incredibly popular. Nearly all women of reproductive age (90%) have used contraceptives throughout their reproductive years, and most have used at least one method of contraception throughout their lifetime (76%). Furthermore, birth control pills have been the most common method of contraception since the 1960s. According to the CDC, 9.1 million people in the United States use the birth control pill. And most women (77%) support moving the birth control pill from behind the counter to the storefront. This initiative is also backed by the American College of Obstetrician Gynecologists, who have determined that increased access to the birth control pill will improve reproductive health outcomes. The initiative is also backed by the American College of Obstetrician Gynecologists, who have determined that increased access to the birth control pill will improve reproductive health outcomes.
We urge the FDA to strongly consider the science that supports the need for OTC birth control options, and the larger social context that has prevented women from readily accessing essential reproductive health care. Comparatively, women in the United States experience worse health outcomes and report less satisfaction with the quality of care they receive than women in other high-income countries. Excessive barriers to care and systemic racism - both of which are at play in the birth control policy space - dilute women’s access to high-quality, comprehensive reproductive health care. The birth control pill and other contraceptive methods have been held out of reach, concealed behind an arduous medical process that disproportionately burdens people of color, LGBTQ+ people and other marginalized communities.
Evidence suggests that increased access to birth control decreases the number of unintended pregnancies. Most relevantly, Black women, who are most affected by the ongoing maternal health crisis, are less likely to report using contraception. Due to the legacy of coercive contraceptive practices, Black women in the United States have often been deprived of their rightful power to make decisions over their own reproduction. In general, Medicaid users and uninsured people are less likely to report using birth control than people with private insurance. Evidence suggests OTC contraception will help to bridge gaps in access among people of color.
More than 19 million women of reproductive age living in the United States live in a contraceptive desert. People living in rural communities are more likely to live in a contraceptive desert and less likely to report using contraception. Rural contraceptive decisions are molded by a myriad of factors such as physician shortages, long travel distances and pharmacy closures. Presently, seven states allow pharmacists to refuse to fill legally prescribed prescriptions. If a pharmacist refuses to fill an order for contraception in an urban or suburban setting, a patient can quickly fill their order at a different pharmacy. Women living in rural areas have fewer options.
To achieve true reproductive justice in the U.S., women need access to the full range of contraceptive services unhindered by medically unnecessary restrictions.
Beyond the social context and demonstrated need, the science tells us that oral contraception is safe. Oral contraception meets the FDA’s criteria for OTC medications. As referenced by the Free the Pill Coalition in their letter to the FDA last year, birth control pills 1) have no significant toxicity if overdosed, 2) they are non-addictive, 3) users can self-diagnose appropriate symptoms, and 4) users can take this drug without a physician screening. Unlike other birth control pills, Opill only contains progestin, rather than the combination of progestin and estrogen. Some health experts have expressed concerns over OTC oral contraception due to blood clots, however, the risk for blood clots is considerably lower in progestin only birth control. Currently, the birth control pill is being sold over the counter in more than 100 countries globally. It is time for the United States joins the ranks of countries around the world to increase access to reproductive health care. The United States has moved countless drugs from behind the counter to the storefront, many of which are less essential and less safe than birth control.
As maternal health outcomes worsen and the number of unintended pregnancies continues to increase, it is important that women across the United States are empowered to make their own reproductive decisions. The National Women’s Health Network urges the FDA to remove medically unnecessary barriers to the birth control pill and approve HRA Pharma’s request to make Opill an over-the-counter drug.
Denise Hyater Lindenmuth,
National Women's Health Network
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