Approved the 1st over-the-counter contraceptive pill in the US – 07/13/2023 – Health

The FDA (agency that regulates and oversees food and medicine in the US) approved this Thursday (13) a contraceptive pill to be sold without a prescription for the first time in the country, a milestone that could expand access to contraception.

The drug, called Opill, will be the most effective birth control method available over the counter — better at preventing pregnancy than condoms, spermicides and other over-the-counter methods. Reproductive health experts said their offering could be especially helpful for young women, teenagers and those struggling with the time, cost or logistical hurdles involved in visiting a doctor to obtain a prescription.

The pill’s maker, Perrigo Co., based in Dublin (Ireland), said that Opill will likely be available in stores and online retailers in the United States in early 2024.

The company did not say how much the drug will cost – a key question that will help determine how many people will use the pill – but Freìdeìrique Welgryn, Perrigo’s global vice president of women’s health, said the company is committed to making the pill affordable and affordable. economical for women and people of all ages.

Welgryn also said the company will have a consumer assistance program to provide the pill for free to some women.

“Today’s approval marks the first time that an over-the-counter daily oral contraceptive will be an available option for millions of people in the United States,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

“Used as directed, daily oral contraception is safe and is expected to be more effective than currently available over-the-counter contraceptive methods for preventing unwanted pregnancy.”

Since the US Supreme Court overturned the national right to abortion last year, access to contraception has become an increasingly pressing issue. But long before that, the movement to offer an over-the-counter pill for all ages received widespread support from reproductive and adolescent health experts and groups such as the American Medical Association, the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians. .

In a survey last year by the health research organization KFF, more than three-quarters of women of reproductive age said they preferred an over-the-counter pill, mainly because of convenience. Nearly 40% said they were likely to use it. Those most likely to opt for the product include women who already take birth control pills, women without health insurance and Hispanic women, according to the survey.

And surprisingly, in a time of sharp divisions over abortion, many anti-abortion groups have refused to criticize over-the-counter birth control. Opposition seems to come mainly from some Catholic organizations and Students for Life Action.

In May, a panel of 17 FDA independent scientific advisors — including obstetrician-gynecologists, experts in adolescent medicine, breast cancer, consumer health behavior and health information — unanimously voted that the benefits of making an over-the-counter birth control pill available far outweigh the risks.

The panel cited Opill’s long history of safety and efficacy, which was approved for prescription use 50 years ago. The over-the-counter pill will be identical to the prescription version, which is 93% effective at preventing pregnancy with normal use.

Several panelists said there is a pressing public health need for an over-the-counter option in a country where nearly half of all pregnancies are unintended.

“The evidence shows that the benefits clearly outweigh the risks,” said advisory committee member Kathryn Curtis, a health scientist in the Centers for Disease Control and Prevention’s (CDC) Division of Reproductive Health.

She added, “I think Opill has the potential to have a huge positive impact on public health.”

For advocates of over-the-counter pills, the main problem is the price.

“If made equitably available – which means affordable and fully insured – OTC birth control pills will be a game-changer for communities affected by systemic health inequalities,” said Dr Daniel Grossman, director of Advancing New Standards in Reproductive Health, which has led research on over-the-counter contraception.

The Access to Health Act requires health plans to pay for prescription contraception, but not for over-the-counter methods. Some states have laws requiring over-the-counter birth control coverage, but most states do not. The KFF survey found that 10% of women would be unable or unwilling to pay any direct costs for contraception. About 40% would pay $10 or less a month, and about a third would pay $20 or less.

Under a recent executive order from President Joe Biden, the federal government could soon take action to require insurers to cover over-the-counter birth control. And Democratic senators have re-introduced legislation to require such coverage.

“We need to make it accessible and available,” Democratic Senator Patty Murray of Washington, a co-sponsor of the bill, said in an interview in May. “Let’s give women what they need and make sure it’s affordable so there’s equity, and low-income women, women who for whatever reason are in trouble, are forced to not have any birth control simply because they can’t afford it.” added.

Opill is known as a “mini-pill” because it contains only one hormone, progestogen, in contrast to “combination” pills, which contain both progestogen and estrogen. A company that makes a combination pill, Cadence Health, is also in discussions with the FDA about the over-the-counter application.

FDA analysts who reviewed the data that Perrigo submitted in its prescription waiver application for Opill raised concerns about whether women with medical conditions that prevent them from taking birth control pills — particularly breast cancer and undiagnosed vaginal bleeding — would follow the warnings and would avoid the product. FDA analysts also raised questions about whether younger teens and people with limited training could follow the instructions.

Several members of the advisory committee said that patients with breast cancer, the leading medical condition that precludes the use of hormonal contraceptives, often have physicians advising them to avoid birth control pills. They also said that Opill may actually be safer for teenagers because they are very unlikely to get breast cancer. And because young women often start with contraceptives they can buy without a prescription, it’s especially important that they have easy access to a method that’s more effective than condoms and other contraceptive products available in retail stores, speakers said.

Perrigo reported that participants in one study took Opill on 92.5% of the days they were supposed to take it. Most participants who missed a pill reported that they followed label instructions to take mitigating measures, such as abstaining from sex or using a condom, Dr. Stephanie Sober, the company’s US medical liaison, said at the advisory committee hearing. She said that out of 955 participants, only six became pregnant while using Opill.

Most people who said they missed doses attributed this to running out of pills before they could reach a study refill site. These results, Sober said, “precisely illustrate the barriers to adherence that could be lowered” by making the pill available without a prescription.