FDA Approves America’s First Over-the-Counter Oral Contraceptive

WASHINGTON (AP) — US authorities have approved the first over-the-counter contraceptive. This will allow American women and girls to purchase contraceptives in the same aisle as aspirin and eye drops.

The Food and Drug Administration announced Thursday that it has allowed Perrigo’s once-daily opil to be sold without a prescription, the first such drug to be moved from behind a pharmacy counter. The company plans to start shipping the tablets by early next year, and there is no age limit for sales.

Hormone-based pills have long been the most popular method of birth control in the United States, and have been used by tens of millions of women since the 1960s. Everything used to require a prescription.

Medical societies and women’s health groups are calling for broader access, noting that an estimated 45% of the six million pregnancies in the United States each year are unintended. Teens and girls, women of color, and people on low incomes report higher hurdles to getting and receiving prescriptions.

Challenges include paying doctor’s fees, taking time off from work, and securing child care.

“This is truly a transformation in access to contraceptive care,” said Kelly Blanchard, chairman of the nonprofit Ibis Reproductive Health, which supported the approval. “I hope this helps people overcome the barriers that currently exist.”

Ireland-based Perrigo has not announced pricing. Over-the-counter drugs are generally much cheaper than prescription drugs, but are not covered by insurance.

In recent decades, many common medicines have transitioned to prescription-free status, including pain, heartburn, and allergy medications.

Perrigo has submitted years of research to the FDA to show that women can understand how to use the pill and follow directions. Thursday’s approval came despite FDA scientists’ concerns about the company’s results, including whether women with certain underlying conditions would understand that the drug shouldn’t be taken.

FDA action applies only to Opill. This is an older class of birth control pills, sometimes called minipills, that contain a single synthetic hormone and have fewer side effects than the more commonly known multi-hormonal tablets.

But women’s health advocates hope the decision will open up more over-the-counter contraceptive options and eventually pave the way for abortion pills to do the same.

However, the FDA’s decision has nothing to do with the ongoing legal battle over the abortion drug mifepristone. The study of Perrigo’s FDA application began several years before the Supreme Court’s reversed Roe v. Wade ruling that overturned access to abortion across the United States.

As some states cut women’s reproductive rights, the FDA is under pressure from Democratic politicians, health advocates and medical professionals to make contraception easier to access. The American Medical Association and the Leading Professional Association of Obstetricians and Gynecologists have endorsed Opil’s over-the-counter marketing application.

An external panel of FDA advisers voted unanimously in favor of the switch at a hearing in May when dozens of hearings called for Opil’s approval.

Divya Huytron, one of the speakers, explained how she had not received a prescription for contraceptives after more than three years of sexual activity. A 19-year-old student at the University of Alabama said she still resists getting a prescription because her school’s health system reports physical exams and medications to parents.

“My parents didn’t let me take the pill,” Hoytron said in a recent interview. “There have been many cultural prejudices regarding sexual activity before marriage.”

She uses other forms of birth control, but “I would have always wanted to be on birth control and use these additional methods to be as safe as possible.”

Hoytron spoke on behalf of Advocates for Youth, one of dozens of groups promoting greater access to prescription contraceptives.

These groups funded some of the research submitted for Opill and encouraged HRA Pharma, later acquired by Perrigo, to submit an application to the FDA.

Proponents were particularly interested in Opill because it poses fewer safety concerns. The tablet was first approved in the United States 50 years ago, but has not been sold in the United States since 2005.

“This drug has been around for quite some time and there is a wealth of data supporting that the pill is safe and effective for over-the-counter use,” said Blanchard of Ibsys Reproductive Health.

New birth control pills usually combine two hormones, estrogen and progestin, to help make your periods lighter and more regular. However, their use increases the risk of blood clots and should not be used by women at risk of heart disease, such as smokers and women over the age of 35.

Opil contains only progestin, which prevents pregnancy by blocking sperm from reaching the cervix. For best results, it should be taken at approximately the same time each day.

In an internal review published in May, the FDA noted that some women who participated in the Perrigo study had trouble understanding the drug’s label information. In particular, the instructions warn women with a history of breast cancer not to take the pills, as they may promote tumor growth. Women with abnormal vaginal bleeding are also advised to consult their doctor first as this may indicate a medical problem.

Perrigo executives said the company will spend the rest of the year manufacturing the pills and their packaging, which will be available in stores nationwide and online by early next year.