FDA advisers weigh approval of the first over-the-counter birth control pill in the US

It was like a tale of two birth control pills.

At a hearing Tuesday to discuss 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 was left to contend with two conflicting analyzes of the drug, called Opill.

During the eight-hour session, the pill’s maker, Perrigo-owned HRA Pharma, and representatives from many medical organizations and reproductive health specialists said the data strongly supported approval. They said Opill, approved as a prescription drug 50 years ago, is safe, effective and easy for women of all ages to use appropriately – and that over-the-counter availability is desperately needed to reduce the country’s high rate of unintended pregnancy .

In contrast, FDA scientists questioned the reliability of the company’s data, which purported to show that users would take the pill at roughly the same time each day and follow instructions to abstain from sex or temporarily use another birth control if they miss a dose. The agency seems particularly concerned about whether women with breast cancer or unexplained vaginal bleeding will correctly choose not to take Opill, and whether adolescents and people with limited literacy will use it accurately.

“I’m really quite confused by the level of inconsistency,” said one of the advisory panel members, Pamela Shaw, a senior investigator at Kaiser Permanente Washington, after both sides made presentations.

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

The move to make the over-the-counter pill available to all ages has garnered overwhelming support from reproductive and adolescent health professionals 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 by the health research organization KFF, more than three-quarters of women of reproductive age prefer over-the-counter pills, mainly because of convenience.

Strikingly, at a time of bitter divisions over abortion, including the abortion pill, many anti-abortion groups have refused to criticize over-the-counter birth control. Opposition seems to come mostly from some Catholic organizations. Support was expressed in the vast majority of hundreds of comments submitted before Tuesday’s hearing and by most of the 37 people who spoke during the public comment portion of the hearing.

“As a teenager, my doctor told me I shouldn’t start birth control pills because it would make me more likely to become sexually active,” said one of the speakers, Rebecca Heimbrock, a 20-year-old college student. “Of course, we know that’s not true, and young people without access to birth control are just having sex without birth control.”

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

Dr. Daniel Grossman, a professor of obstetrics, gynecology and reproductive sciences at UC San Francisco, who spoke in support of the over-the-counter effort in public comments Tuesday, said both types of pills are safe and about 93 percent effective in preventing pregnancy in typical use.

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

Progestin-only pills, which thicken the cervical lining to make it harder for sperm to fertilize eggs and can also disrupt egg release, have virtually no risk of causing blood clots. The data suggest that it may be more important to take progestin-only pills within the same three-hour window each day, while combination pills allow for a little more flexibility, he said.

Dr. Pamela Horne, director of the FDA’s division of nonprescription drugs, said Tuesday that she “cares deeply about women’s health” and would be “happy to have unequivocal data” to support the app.

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

The FDA highlighted the fact that about 30 percent of study participants reported taking more pills than they were prescribed, a phenomenon called “over-reading” or “improbable dosing.” Dr. Jeena Jacob, the FDA’s chief medical officer, said this raised concerns about those participants, as well as the possibility that “other participants not part of the improbable dosing group may have misused or misreported use.”

And Dr. Karen Murray, deputy director of the agency’s Office of Over-the-Counter Drugs, dismissed the oft-cited figure that more than 100 states have over-the-counter pills. She said pharmacists dispense such pills in most of those countries, so Americans’ experiences may be different. Here, she said, “if this product is approved, people might get it at a drug store, but they could also get it at a gas station or a big box store with no health professionals around.”

Presentations in support of the company made a very different case.

“Despite the availability of various contraceptive methods, nearly half of pregnancies are unintended each year,” testified 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, are less effective than the pill, adding: “We need more effective methods that are available over the counter.”

Dr. Westhoff suggested that for most women, there is no advantage to having a doctor prescribe the pills because doctors typically do not monitor patient adherence 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 face the most significant barriers to accessing the more effective methods.”

Other speakers, including some who spoke during the public comment session, emphasized that the product would also benefit women from low-income, rural and marginalized communities who lack insurance or find it difficult to see a doctor for a prescription due to the cost 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 use it. The company’s study found that 97 percent of breast cancer patients correctly chose not to take the pill.

The study reported that participants took the pill on 92.5 percent of the days they were supposed to take it, Dr. Stephanie Sober, the company’s U.S. medical liaison. She said almost 85 percent of participants took a pill on at least 85 percent of days. Most participants who missed a pill reported that they followed label directions to take mitigating measures such as abstaining from sex or using a condom, Dr. Sober said, adding that among 955 participants, only six women became pregnant while using 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 majority of women did just that. And if they made a mistake, most took appropriate mitigation measures. And let’s remember that women who missed pills often did so because they could only get them from the site where they signed up, whereas in the real situation they could have bought a pill from any pharmacy.

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