FDA panel backs approval of first over-the-counter birth control pill

Perrigo Co.’s over-the-counter Opill gained a key recommendation from US regulatory advisers, paving the way for the birth-control pill to get clearance to be sold without a prescription.

Members of two Food and Drug Administration advisory committees voted 17-0 in support of using the progestin-only pill without a prescription, citing studies that support consumers’ ability to use the pill properly and touting its public health benefit. The agency isn’t required to follow its advisers’ recommendations, but often does.

Reproductive rights advocates have long argued that the prescription-only system creates unnecessary barriers to access and that oral contraception should be available without a prescription, as it is in more than 100 other countries. If the FDA chooses to approve Opill for over-the-counter use, it will become the first daily, nonprescription oral contraceptive in the US, removing a substantial barrier to access many Americans have faced.

Related: More than 75% of females favor over-the-counter birth control pills

The members voted to support nonprescription use even after the FDA staff said the company didn’t address Opill’s effectiveness among women who are overweight or obese, health conditions that have become increasingly common in the US since Opill’s initial approval via prescription in 1973.

“Recent approval of hormonal contraceptives have shown that efficacy may be decreased as much as 40% in females with increasing BMI,” said Anandi Kotak, medical officer in the division of urology, obstetrics and gynecology at the FDA.

The pill is a $100 million opportunity for Perrigo and the shares look “increasingly compelling,” wrote JPMorgan analysts led by Chris Schott in a note to clients. They rose as much as 5.9% as of 2:05 p.m. in New York. The decision is a “new, groundbreaking chapter in reproductive health,” Perrigo Chief Executive Officer Murray Kessler said in a statement.

Weight concerns

About 60% of reproductive-aged Americans are overweight or obese, according to the latest data from the National Institute of Diabetes and Digestive and Kidney Diseases. Alison Edelman, an obstetrician and gynecologist at Oregon Health & Science University, was part of a team that studied how the pill performed at baseline and what happens if a dose is missed or taken late.

In those studies, Opill “performed consistently in individuals of varying weight/BMI including those with an overweight or obese BMI,” according to Edelman, who called the results “reassuring.”

Progestin-only pills like Opill are safe in most people, which makes them a great option for over-the-counter use, Edelman said. People who have or had breast cancer or are pregnant shouldn’t take them, she said.

Access to reproductive health care has come under increasing threat. Last month a Texas federal judge’s decision threatened to restrict nationwide access to the abortion pill mifepristone, a decision almost immediately followed by a conflicting ruling from a federal judge in Washington state who instructed the government to preserve access to the pill. The Supreme Court eventually stepped in and ultimately decided to leave the medication on the market while the legal battle played out.

HRA Pharma, Perrigo’s unit that makes the drug, sought FDA approval for an over-the-counter version last summer after the Supreme Court overturned the landmark Roe v. Wade ruling, curbing access to abortion in some parts of the country. That meeting was postponed until May because the agency wanted more information from the company.

The company expects that the FDA’s final decision will come by the end of summer in the US. Advocates, including Free the Pill project director Victoria Nichols, called on the FDA to follow the committee’s recommendation.

“It is past time for an over-the-counter birth control pill, which has the potential to advance reproductive justice and expand health equity,” Nichols said in a statement. “The days of the current prescription requirement are numbered.”

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