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FDA weighs potential over-the-counter birth control pill

FDA will make final decision on approval in the coming months

FDA advisers on Wednesday voted 17-0 to recommend the agency approve the nation’s first over-the-counter birth control pill.
FDA advisers on Wednesday voted 17-0 to recommend the agency approve the nation’s first over-the-counter birth control pill. (BSIP/Universal Images Group via Getty Image file photo)

Food and Drug Administration advisers on Wednesday unanimously recommended the agency approve the nation’s first over-the-counter birth control pill, although it’s unclear what the FDA will ultimately decide in the coming months.

The 17-0 vote capped a two-day joint committee meeting where FDA officials and Perrigo Co. PLC subsidiary HRA Pharma sparred over each other’s interpretation of safety and efficacy data of the progestin-only Opill. It was approved as a prescription drug in 1973, but the joint committee was tasked with assessing whether consumers would use the pill properly if it were sold on store shelves without a prescription.

FDA officials said they understood the importance of over-the-counter contraceptives, but were struggling with what they called flaws in the company’s data. A final decision is expected by the end of summer.

Advocates and medical groups hailed the recommendation and urged the agency to follow suit.

“It is past time for an over-the-counter birth control pill, which has the potential to advance reproductive justice and expand health equity,” said Victoria Nichols, project director of the Free the Pill coalition.

“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 health care options,” American Medical Association President Jack Resneck Jr. said in a statement. “We urge the FDA to act swiftly to approve over-the-counter access to oral contraceptives without an age restriction.”

A broader push

The push to broaden and protect access to contraception has accelerated following the Supreme Court’s decision to overturn the long-standing constitutional right to an abortion last year.

Lawmakers have introduced legislation to codify the right to birth control in both chambers, and in January the Biden administration proposed rolling back a Trump-era policy that expanded the types of exemptions employers could seek to avoid covering contraception in their health plans.

But Republicans have largely opposed the bills and pushed back on strengthening requirements to cover or dispense contraception.

The stance among anti-abortion groups has been mixed, though access to birth control is broadly popular with the public.

“Contraception is by definition before a human, a unique human being, is formed, so I think people should avoid getting pregnant,” said Susan B. Anthony Pro-Life America President Marjorie Dannenfelser last year. “Because once another human being is formed, there are two patients, two people to consider.”

Nearly half of all 6.1 million pregnancies in the U.S. are unintended, according to the Guttmacher Institute, with teens aged 15 to 19 experiencing the highest rate of unintended pregnancies.

Around 10.2 million women of reproductive age rely on less effective methods like condoms or no contraception at all, according to data that experts presented to the FDA on behalf of HRA Pharma.

Unintended pregnancies are also correlated with higher risks and less prenatal care, increased rates of miscarriage, postpartum depression, premature birth and infant mortality.

Maternal mortality rates are also rising, increasing around 90 percent between 2018 and 2021. The Centers for Disease Control and Prevention estimated that nearly 33 women died per 100,000 births in 2021, up from 17.4 in 2018. Low-income women of color account for the brunt of the deaths, potentially benefiting the most from over-the-counter birth control access.

“While we don’t know which of these pregnancies were unintended, we can assume that many were,” Edinburgh and London universities Professor Anna Glasier said in testimony on behalf of HRA Pharma. “Regardless, with advancements in medicine, these numbers should be going down, not up.”

The joint committee ultimately concluded the benefits outweighed the risks, especially since consultations with patients on birth control are often fairly quick.

Lingering worries

But some concerns lingered, particularly around adolescents. Sabrina Everhart, a patient representative from Charlestown, Ind., said she wasn’t sure she would trust her 11-year-old granddaughter to understand all the potential risks on her own.

“I do feel like age is an important factor here,” Everhart said.

The clinical studies found no new safety or efficacy problems, but the FDA said some studies on proper usage were flawed and raised questions about the ability of high-risk patients to either opt out or speak to a doctor first.

HRA Pharma argued the FDA’s concerns were overblown and that the agency incorrectly interpreted some data. The FDA, however, said the company’s interpretation was unusual and violated established procedural guidance.

Progestin-only pills have fewer health risks than combination pills — which contain estrogen — but are less popular than combination pills.

Women with breast cancer are at the highest risk of complications from the progestin-only pill. But a large majority of breast cancer patients are 50 or older, which reduces the overlap with birth control users.

Of particular concern to the FDA was the number of patients with irregular vaginal bleeding who did not properly consult a doctor before using the pill, as well as the small number of low-literacy participants in a study aimed at whether breast cancer patients correctly chose not to take the pill.

The company also did not collect data on teen sexual habits, which the FDA said raised questions about how often teen users properly used another form of contraception when they missed a dose.

Unusual concerns arose around electronic reporting during the studies. Roughly one-third of participants over-reported the number of pills they took, a number that one FDA official called “extraordinary.” The number was so high that the FDA cast doubt on the rest of the data because the reviewers could not identify why the over-reporting occurred.

The FDA indicated it was considering asking HRA Pharma to revisit the study, which would delay approval. The joint committee urged against delaying approval but did discuss a variety of potential improvements, like a better compensation structure and access to help when a patient had questions.

HRA Pharma also presented data suggesting that delayed or missed doses did not correlate with changes in overall ovulation or fertility signals.

“These data reassure us that the window for maintaining efficacy if a pill is delayed or missed is likely wider than previously thought,” HRA Pharma women’s medical affairs lead Stephanie Sober said.

The data was not enough to convince officials to widen the recommended three-hour window within which patients take their daily pills, but helped bolster the case for over-the-counter use.

The company also argued that increasing access will help increase adherence. HRA Pharma data showed that 58 percent of participants who missed pills reported that they ran out, while another 12 percent said they did not have them on their person, which the drugmaker argued that over-the-counter access could help prevent. Another 22 percent simply forgot to take the pill.

Access concerns

Opill is currently approved for prescription use for all ages, but over-the-counter access could increase safety concerns by making it available to patients with undiagnosed breast cancer, for example. It could also increase the risk of negative interactions with other common drugs.

Questions about access will remain. HRA Pharma has pledged to make the drug affordable, but has not yet announced a price.

And it’s unclear how broadly insurance plans will cover the pill when it’s bought from a store. Some states have laws requiring health plans to cover over-the-counter birth control pills, but they don’t apply to federally regulated large employer plans.