FDA advisers are weighing the first US over-the-counter birth control pill

It was like a story about two birth control pills.

During a hearing Tuesday to consider whether the Food and Drug Administration should approve the nation’s first over-the-counter birth control pill, a panel of independent medical experts advising the agency had to consider two conflicting analyzes of the medication called Opill.

On Wednesday, the panel will hold a nonbinding vote on whether the risks of an over-the-counter pill outweigh the benefits. The FDA is expected to make a final decision this summer.

During the eight-hour session on Tuesday, the pill’s manufacturer, Perrigo-owned HRA Pharma, and representatives from many medical organizations and reproductive health specialists said the data strongly supported the approval. They said that Opill, approved 50 years ago as a prescription drug, was safe, effective and easy for women of all ages to use properly – and that over-the-counter availability was much needed to overcome the country’s high number of unintended pregnancies. to decrease.

In contrast, FDA scientists questioned the reliability of company data intended to show that consumers would take the pill at about the same time each day and adhere to directions to abstain from sex or temporarily use other contraception if they missed a dose. The agency seemed particularly concerned about whether women with breast cancer or unexplained vaginal bleeding would rightly choose not to use Opill and whether adolescents and people with limited literacy would use it correctly.

“I’m just pretty confused by the degree of discrepancy,” said an advisory panel member, Pamela Shaw, a senior researcher at Kaiser Permanente Washington, after both sides made presentations.

The move to make an over-the-counter pill available to all ages has received a flood of support from reproductive and adolescent health specialists and groups such as the American Medical Associationthe American College of Obstetricians and Gynecologists And the American Academy of Family Physicians.

In a research by the healthcare research organization KFFmore than three-quarters of women of childbearing age preferred an over-the-counter pill primarily because of convenience.

Strikingly, at a time of fierce division over abortion, including abortion pills, many anti-abortion groups have refused to criticize over-the-counter birth control. The resistance seems to come mainly from a few Catholic organizations. Support was expressed in the vast majority of hundreds of comments submitted ahead of Tuesday’s hearing and by most of the 37 people who spoke during the public comment section of the hearing.

“As a teenager, I was told by my doctor not to start on the birth control pill because it would make me more sexually active,” said one speaker, Rebecca Heimbrock, a 20-year-old sophomore. “Of course we know that’s not true, and young people without access to contraception are just having sex without contraception.”

Opill is called a “mini-pill” because it contains only one hormone, progestin, unlike “combined pills,” which contain both progestin and estrogen.

Dr. Daniel Grossman, a professor of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco, speaking in public comments Tuesday in support of the over-the-counter effort, said both types of pills were safe and about 93 percent effective in preventing pregnancy under normal use.

He said that compared to progestin-only pills, more medical conditions would prevent women from taking combination pills, which work by blocking the release of eggs from the ovaries and carry a risk of causing blood clots in some women.

Progestin-only pills, which thicken cervical mucus, make it difficult for sperm to fertilize eggs and can also interfere with egg release, have virtually no risk of causing blood clots. Data has suggested that it may be more important to take progestin-only pills within the same three-hour period every day, while combination pills allow for a little more flexibility, he said.

Dr. Pamela Horn, director of an FDA division for over-the-counter drugs, said Tuesday she “cares deeply about women’s health” and “would like to have unequivocal data” to support the application.

But she said there were many concerns, concluding that “the evidence submitted by the applicant for likelihood of effectiveness in the non-prescription setting is mixed and has many limitations.”

The FDA highlighted the fact that about 30 percent of study participants reported taking more pills than they received, a phenomenon called “overreporting” or “unlikely dosing.” Dr. Jeena Jacob, an FDA medical officer, said concerns arose about those participants, as well as the possibility that “other participants who are not part of the unlikely dosing group may have misused or reported incorrectly.”

And dr. Karen Murry, deputy director of the agency’s Office of Nonprescription Drugs, pushed back on a much-cited figure that more than 100 countries have over-the-counter pills. She said pharmacists dispense such pills in most of those countries, so Americans’ experience may be different. Here, she said, “if this product is approved, people can get it in a pharmacy, but they can also get it in a gas station or a big box store with no healthcare providers around.”

Presentations in support of the company made a completely different story.

“Despite the availability of various contraceptive methods, nearly half of pregnancies each year are unintended,” Dr. Carolyn Westhoff, an obstetrician-gynecologist at Columbia University’s Mailman School of Public Health. She noted that other over-the-counter methods, such as condoms, were less effective than the pill, adding, “We need more effective over-the-counter methods.”

Dr. Westhoff suggested that there is no benefit to most women for a doctor to prescribe the pills because doctors usually do not monitor patient compliance and often see such patients only once a year. She said it was especially important to make the pill available to adolescents because “these youngest women experienced the greatest barriers to accessing the more effective methods.”

Other speakers, including some who spoke at the public commentary session, emphasized that the product would also be helpful to women in low-income, rural and marginalized communities who lacked insurance or found it difficult to go to a doctor for a prescription because of the costs of time, transportation or childcare.

Dr. Pamela Goodwin, a breast cancer oncologist at Sinai Health System in Toronto, testified that very few breast cancer patients would be at risk because their doctors would advise them not to take it. The company’s study found that 97 percent of breast cancer patients rightly chose not to take the pill.

According to dr. Stephanie Sober, the US medical contact for the company, the participants had taken the pill on 92.5 percent of the days they should have taken the pill. She said nearly 85 percent of the participants took a pill on at least 85 percent of the days. Most participants who missed a pill reported following label directions to take mitigating measures, such as abstaining from sex or using a condom, said Dr. Sober, adding that of the 955 participants, only six women had become pregnant while taking Opill.

“Let’s face it – the instructions for using Opill are extremely simple: take one pill at the same time every day,” said Dr. Anna Glasier, a British reproductive health expert who testified for the company. “The vast majority of women did just that. And when they made a mistake, most took appropriate mitigation measures. And let’s not forget that the women who did miss pills often did so because they could only get a supply from the site where they signed up, when in the real world they could have bought a pill from any drugstore.