FDA approves first over-the-counter birth control pill in U.S. – The Washington Post

Article repost by The Washington Post: https://www.washingtonpost.com/health/2023/07/13/birth-control-pill-over-the-counter-fda-approval/

Federal regulators Thursday approved the first over-the-counter birth control pill available in the United States, a milestone in decades-long efforts to make oral contraceptives easier to obtain, especially by teenagers and women who don’t regularly see a doctor.

The Food and Drug Administration’s approval of Opill, made by the consumer health giant Perrigo, comes six decades after daily birth control pills were introduced in the United States, drastically changing the lives of countless women and American society. And it means the country will join about 100 other nations that allow the sale of nonprescription birth control pills.

Health experts, citing the pill’s lengthy record of safety and effectiveness, have pushed for a nonprescription pill for years, but their campaign took on new urgency after the Supreme Court last year struck down the fundamental right to abortion established by Roe v. Wade.

“It’s a transformative change in contraceptive access and reproductive health,” said Victoria Nichols, project director of Free the Pill, a coalition of dozens of groups working for over-the-counter birth control pills in the United States.

Opill is expected to be available over the counter in stores starting in January or February, according to Perrigo. It will not have an age restriction. The suggested retail price is expected to be announced this fall. The FDA decision applies only to Opill, not to other birth control pills.

Dyvia Huitron, who is 19 and lives in McAllen, Tex., was 16 when she started having sex and was not able to get the pill; she said she used condoms. Her parents told her to stop having sex. Huitron said several of her friends becamepregnant in high school.

“Young people absolutely need this,” said Huitron, a member of Advocates for Youth, a nonprofit organization that has been pressing for easier access to birth control. “For them to be able to get something so important in terms of taking care of their bodies, at an age when historically we have not been allowed to … it will have a really significant impact on our lives and our ability to plan for the future.”

The OTC decision comes amid ongoing turmoil following the decision overturning Roe. Today, about a quarter of women of reproductive age live in states where abortion is banned or mostly banned, withdozens of clinics across the South and Midwest no longer providing abortions. New restrictions have led to almost 25,000 fewer legal abortions.

Among the biggest outstanding questions about Opill: cost and insurance coverage. The company has said it would keep the drug affordable and offer financial assistance to people who qualify.

Under the Affordable Care Act, group health plans and insurance companies are required to cover women’s preventive services, including birth control, at no cost. But that applies to prescription products; typically, insurers do not cover OTC drugs — something that women’s health groups want the Biden administration to change.

Some states require the insurance companies they regulate to cover contraceptive products sold without a prescription, according to the Guttmacher Institute, a research group that supports abortion rights. Almost 30 states and the District of Columbia allow pharmacists to write prescriptions for contraceptives, but some of the laws have age and other restrictions.

Almost half of the pregnancies in the United States are unplanned, according to the Centers for Disease Control and Prevention. Because Opill has been shown to be more effective than other forms of contraception, such as condoms, experts say it could reduce the number of unintended pregnancies.

Major medical groups, including the American College of Obstetricians and Gynecologists and the American Medical Association, have called for the change for years, saying nonprescription pills could be a boon for public health.

Opill, also called norgestrel, is sometimes called a “mini pill” because it contains only progestin, a synthetic form of the hormone progesterone. It works by thickening cervical mucus to inhibit sperm and suppressing ovulation. Opill does not contain a synthetic form of the hormone estrogen.

Birth control pills that contain both progestin and a synthetic form of estrogen — called combination pills — are more popular in the United States than progestin-only pills. But there are more medical conditions, including blood clots, that preclude use of those combination pills.

The first birth control pill was approved in 1960. Norgestrel was first cleared in 1973 under the brand name Ovrette. It was discontinued by Pfizer in 2005 for businessreasons.

HRA Pharma, a Paris company, acquired the medication in 2014 and in recent years has worked closely with Ibis Reproductive Health, a Cambridge, Mass., research group that heads Free the Pill. HRA Pharma applied to the FDA for over-the-counter status for the drug in July 2022 shortly after being acquired by Perrigo, a giant Dublin-based manufacturer of generic medications.

Perrigo applauded FDA’s approval Thursday.

“Today marks a truly momentous day for women’s health nationwide,” said Patrick Lockwood-Taylor, Perrigo’s president and chief executive officer. He said Opill has the potential to sharply improve access to contraception.

In May, outside experts advising the FDA voted unanimously that the benefits of approving OTC status for Opill outweigh the risks. They overrode reservations expressed by agency staffers who wondered whether physician oversight might be needed to ensure the pill was used safely and effectively.

The staffers were especially concerned that women might not adhere to directions to take the pill every day, at about the same time, and to use another form of contraception or abstain from sex if they missed a dose. They also worried that some women with breast cancer and other medical conditions might not follow instructions to avoid the medications.

Opposition to Opill’s application for nonprescription status mostly came from Catholic groups that have traditionally opposed birth control in favor of natural family planning methods that rely on tracking a woman’s cycle, and fertility, throughout the month. Catholic groups that oppose OTC status focus, in part, on safety issues.

“We strenuously oppose the non-prescription availability of Opill,” the U.S. Conference of Catholic Bishops, National Catholic Bioethics Center, Catholic Medical Association and National Association of Catholic Nurses wrote to the FDA’s outside advisers in November.

Antiabortion groups that pushed hard to dismantle Roe have not spent a lot of time focusing on oral contraceptives.

See also: https://www.washingtonpost.com/health/2023/07/13/birth-control-pill-over-the-counter-fda-approval/