FDA advisory panel endorses OTC birth control

Over two days of deliberation, members of two FDA advisory committees considered whether patients could safely and effectively take the birth control drug Opill without first consulting a healthcare provider.

Opill, which is manufactured by Perrigo's HRA Pharma, is a progestin-only pill. Progestin is a synthetic version of progesterone, which prevents pregnancy by blocking sperm from entering the cervix. It is currently only available by prescription.

In a 17-0 vote, the committee members endorsed making Opill available OTC, saying consumers would likely be able to take the oral contraceptive correctly on their own and that the benefits outweighed the risks.

According to the advisors, Opill, which was approved for prescription use 50 years ago, has a long history of safety and efficacy, and having it available OTC could greatly benefit public health in the United States.

"The panel expresses confidence in the effectiveness, not only in the general population of females, but also in adolescent populations and those with limited literacy," said Maria Coyle, chair of the committee, a pharmacist and an associate clinical professor at The Ohio State University. "The panel seems very comfortable with the limited number of risks from the medication itself."

"The evidence demonstrates that the benefits clearly exceed the risks," said Kathyrn Curtis, a health scientist in CDC's division of reproductive health and one of the committee members. "The benefits of moving Opill over the counter include increased access to contraception ... reduction in unintended pregnancy and associated risks, and improved reproductive autonomy and improved equitable access to contraception."

According to Perrigo president and CEO Murray Kessler, the panel's vote to recommend FDA make Opill available OTC marks a "new, groundbreaking chapter in reproductive health."

Frederique Welgryn, Perrigo's global VP for women's health, added that FDA's potential approval "would address a key unmet need for contraceptive access and be a step forward toward ensuring people have improved access to contraception without unnecessary barriers."

Reaction

The panel's decision was applauded by major medical groups, including the American College of Obstetricians and Gynecologists and the American Medical Association (AMA).

"More than 60 years of safe and effective use of oral contraceptives have shown that the benefits of widespread, nonprescription availability far outweigh the limited risk associated with their use," said AMA president Jack Resneck Jr.

"At this tumultuous time for reproductive health in the United States, allowing access to OTC oral contraceptives is a safe and necessary step that must be taken to ensure that all individuals are able to effectively limit unintended pregnancies, particularly those with limited access to healthcare options," Resneck said.

"I think this represents a landmark in our history of women's health. Unwanted pregnancies can really derail a woman's life, and especially an adolescent's life," said Margery Gass, a member of the committee from the University of Cincinnati College of Medicine. "So I'm very pleased that the FDA is seriously considering this. And I look forward to it being on the market."

Advocacy groups have also praised the decision, with Victoria Nichols, project director of Free the Pill, saying that it was "a historic step forward for reproductive health."

"Decades of coalition-driven advocacy and research efforts that have centered the voices of those most impacted by barriers to contraception caused by systemic inequities have made this possible," Nichols said. "It is past time for an over-the-counter birth control pill, which has the potential to advance reproductive justice and expand health equity.

What will happen with the pill next?

FDA is expected to make its final decision whether to approve Opill for OTC use this summer or in the early fall. Although the agency typically follows the recommendations of its advisors, it does not have to, and FDA scientists previously raised concerns about whether patients would be able to use the pill correctly and safely.

According to FDA reviewers, there were some concerns about whether individuals with certain medical conditions, such as breast cancer and undiagnosed vaginal bleeding, would follow the labeled warnings and avoid using the product.

In addition, almost a third of participants in Perrigo's "actual use" study of Opill reported taking more pills than they actually would have possessed. FDA officials said this magnitude of overreporting raised concerns about the reliability of the company's data.

"I can't think of a study that had 30 percent invalid data," said Theresa Michele, director of the FDA's Office of Nonprescription Drugs. "We are left with this ambiguity."

For its part, Perrigo said a third-party analysis could not find a clear answer to the overreporting issue, but that it had ruled out a systemic issue that suggested other data was unreliable. The advisory committee also said that it did not believe another study was needed to resolve questions about the data.

"Do I think we got perfect data? No," said Cynthia Baur, director of the Horowitz Center for Health Literacy at the University of Maryland School of Public Health. But she added, "Do I think it was adequate to feel that a large number of people can use this drug as intended? Yes."

Some advocates have also expressed concerns about the affordability of the pill if it's approved for OTC use. "This will not be a win if it is not affordable, covered by insurance and available to folks of all ages," Kelly Blanchard, the president of Ibis Reproductive Health.

Although HRA Pharma has yet to announce the OTC cost of Opill, the company has said it's committed to ensuring that the birth control is "not only accessible but affordable for all women in need." (González, Axios, 5/10; Hensley/Stein, "Shots," NPR, 5/10; Gupta, New York Times, 5/10; Belluck, New York Times, 5/10; McGinley/Roubein, Washington Post, 5/10; Fernando, USA Today, 5/10)

Maternal and reproductive healthcare is rapidly changing. Health leaders must grapple with worsening maternal health disparities, the nationwide maternal mental health crisis, lasting impacts of the  Dobbs v. Jackson  ruling, and the rise of femtech disruptors.  Download the report to gain strategic insights on these drivers.