FOR IMMEDIATE RELEASE
May 10, 2023
Contact: Colleen McCabe (917-410-7240 or colleen@caminopr.com)

FDA expert committee unanimously endorses birth control over the counter

Advisory committee rejects FDA suggestion that further testing be mandated

WASHINGTON — In a major victory for equitable access to contraception, today a Food and Drug Administration Advisory Committee unanimously recommended that the agency make Opill, a progestin-only, daily oral contraceptive pill, available without the medically unnecessary requirement of a prescription.  

The chief medical advisor for the nonprofit Contraceptive Access Initiative praised the committee’s vote.

“The advisory committee followed the scientific evidence and paved the way for a massive breakthrough in access to birth control,” said Dr. Raegan McDonald-Mosley, CEO of Power to Decide, chief medical advisor for CAI and a practicing OB-GYN. “This long overdue advancement is a huge step forward in helping people — no matter who they are or where they live — have the power to decide if, when, and under what circumstances to get pregnant and have a child.” 

CAI urged the FDA to follow the scientific evidence, move swiftly to finalize their assessment and follow the committee’s recommendation to approve Opill for over-the-counter use.

The FDA suggested that they may ask for some of the studies to be re-done, which could significantly delay a decision. The panel had a “strong” objection to additional testing or any delay in approving over-the-counter status; no panelists endorsed the idea of additional testing. 

“In a major step forward for reproductive health, the FDA Advisory Committee firmly rejected the FDA staff’s paternalistic overlay and double standard in its review of the application for over-the-counter status for oral contraception,” CAI Co-founder Dana Singiser said. “Of course people of all ages can read a label, of course women battling serious health issues like breast cancer know to consult with their physicians, and of course the current unprecedented reproductive health crisis demands increased access to reliable contraceptive options. We’ve seen this predictable ‘pink tape’ interrupt the approval of reproductive health products in the past, and after 50 years on the market, it’s well past time for the FDA to swiftly approve over-the-counter access to the pill for all.”

“We look forward to the FDA following the advisory committee's recommendation and the overwhelming science and evidence with final approval this summer. Simultaneously, the Biden administration must ensure equitable access by clarifying that over-the-counter contraception must be covered by insurance plans.”

Unfortunately, in its materials and presentation the FDA staff applied double standards and failed to weigh the enormous public health benefit of increased access to the pill for people of all ages. The advisory committee members rejected this bias and properly evaluated the risks and benefits, based on the science and evidence before them. Many members lifted up the urgency, many cited that the pill is significantly more effective than any other OTC contraception, dispelled any concern that improper dosing has clinical harm, and recognized the urgent need for access to reliable contraception.

For 50 years, women have understood how to properly take the birth control pill. Some of the concerns expressed by the FDA and some FDA committee members were controversial given the strong safety record of this product, including:

  • Whether women would be confused about whether they should take the birth control pill by mouth or would inaccurately insert the pill into their vagina, which committee member Dr. Roth called “mansplaining” considering the medication is called “oral contraception.”;

  • Suggesting that teen participants in the study should have reported on a daily basis during the study whether they had engaged in intercourse that day;

  • Once a minority of participants misreported how many pills they took, casting doubt on the integrity of all of the participants;

  • Using the same tools that have been accepted in other studies, such as the REALM tool used to evaluate medical literacy, which was just used by the FDA in 2023 to approve Naloxone OTC.

  • Holding adherence to taking the pill OTC to a HIGHER standard than prescription users have exhibited. 

  • Highlighting concerns about consumers with a history or diagnosis of breast cancer without considering that women with breast cancer are under the care of an oncologist and are highly aware that they should avoid oral contraception.

  • Casting doubt on the efficacy (i.e. effectiveness) of the pill, despite overwhelming evidence over 50 years that the pill works. 

  • Questioning the entire body of previous studies presented to the FDA related to the POP, an unprecedented new standard which would call into question the basis for any OTC switch application and other FDA drug reviews.

The historic recommendation comes at the same time that a new poll finds overwhelming, nationwide support for over-the-counter access to the pill across all demographics. An astounding 78% of voters found it “personally important that the U.S. make access to the pill and other contraceptives more easily available.”

A second birth control pill is moving toward the final stages of the FDA review and approval process. The FDA is also working with a second company, Cadence OTC, on an over-the-counter application for the most commonly taken birth control pill, a combined estrogen-and-progestin pill taken by 95% of pill users. Cadence has not yet completed its final testing on its product, Zena.

In June 2022, the American Medical Association urged the FDA to make the birth control pill available over the counter (OTC) for all ages — joining the American College of Obstetricians and Gynecologists, American Academy of Family Physicians and many other medical groups.

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The nonprofit Contraceptive Access Initiative (CAI) advocates for increasing access to hormonal contraception over the counter, free from stigma, bias and coercion. Follow CAI on Twitter @ThePillOTC and on LinkedIn.