What To Know About Opill —The Birth Control Pill FDA Advisors Support Making Available Over-The-Counter

Topline

A panel of independent experts voted unanimously to recommend the Food and Drug Administration make birth control pill Opill available over-the-counter without a prescription, an endorsement that could transform how contraception is accessed in the U.S. at a time when reproductive rights have become a highly divisive, hot button issue.

The FDA is considering approving the country’s first over-the-counter contraceptive pill.

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Key Facts

Opill is a contraceptive pill manufactured by Perrigo, which acquired the drug when it bought French drug firm HRA Pharma last year.

The FDA approved Opill as a prescription drug in 1973 and it must be taken daily.

It only contains one hormone, progestin (a synthetic form of progesterone)—leading to its nickname “the mini pill”—and helps prevent pregnancy by stopping ovulation, thinning the lining of the uterus and preventing sperm from reaching an egg by thickening mucus in the cervix.

Progestin-only pills are considered safer alternatives to combination pills (which also contain estrogen) with fewer side effects and health risks but they are less effective unless taken at the same time each day.

Though the panel voted unanimously for the FDA to authorize over-the-counter sales of Opill, members raised questions, including whether the pill would be less effective in overweight people, whether some groups—notably younger users and those with limited literacy skills—would follow instructions properly, and whether those with conditions like unexplained vaginal bleeding or breast cancer would rightly choose not to take the drug.

Ultimately, the panel endorsed the pill on evidence suggesting it is safe, effective and fills an important public health need, with members saying women are more likely to be harmed by unintended pregnancies than the drug’s side effects.

News Peg

The panel’s recommendation comes after two days of deliberations weighing years’ worth of evidence on the pill. The panel’s endorsement was celebrated by advocacy groups like Free the Pill and follows years of work and advocacy from medical groups, activists and clinicians. It also comes at a fraught time for reproductive rights, which have been positioned front and center in national discourse since the Supreme Court overturned Roe v. Wade last year, which led multiple states to severely curtail access to abortion and is driving current efforts to prohibit abortion drug mifepristone. While the review of Opill is unrelated to discussion regarding abortion, it has nevertheless become entangled in the broader national debate over reproductive rights. There is concern FDA officials will be pressured to act one way or another given the highly charged political nature of the subject.

What To Watch For

The FDA still needs to make a final decision on Opill. While the agency does not have to follow its advisors’ recommendations, it often does, and a final decision is expected in the summer. If approved, Opill will be the first over-the-counter birth control pill available in the U.S.

What We Don’t Know

It’s not clear if or when another company might follow Perrigo’s footsteps in trying to make its products available without prescription. Activists have worked for decades to expand access to birth control and unlike many pharma firms the companies that sell birth control over the counter must tread a particularly delicate political path when gaining approval. Cadence Health, a U.S. company that makes a “combination” pill combining progestin and estrogen, has reportedly been in talks with the FDA for years about switching to over-the-counter sales. Cadence has yet to submit a formal application with the FDA but is reportedly planning to do so in the near future, according to the New York Times. Cadence did not immediately respond to Forbes’ request for comment.

Key Background

Unintended pregnancies account for around half of all pregnancies in the U.S. and are an important public health issue. Broadly considered, unintended pregnancies are pregnancies that are either unwanted or mistimed. They raise an array of social and economic issues in addition to a number of health issues for both pregnant person and the resulting child(ren), including greater risks of maternal depression and anxiety, being less likely to breastfeed and giving birth prematurely. Access is commonly cited as a reason for failing to take or stopping contraception and removing the barrier of needing a prescription will go some way toward addressing this problem. Many medical organizations—including the American Medical Association (AMA), the American Academy of Family Physicians and the American College of Obstetricians & Gynecologists—support making contraceptive pills available over the counter, with the AMA calling it an “easy call from a public health perspective.” More than 100 countries already allow birth control to be sold over the counter, including the U.K., Russia, China and India.

Big Number

15 million. That’s how many women there are in the U.S. who do not use birth control or rely on less effective methods like condoms or behavioral methods, estimates the pill’s maker Perrigo. The figure represents around one-fifth of those of childbearing age.