FDA advisers are considering 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 over whether the Food and Drug Administration should approve the country’s first over-the-counter birth control pill, a panel of independent medical experts advising the agency faced two conflicting analyzes of the drug, called Opill.
During the eight-hour session, the pill’s manufacturer, HRA Pharma, which is owned by Perrigo, along with representatives from many medical organizations and reproductive health specialists, said the data strongly supports the approval. They said Opill, which was approved as a prescription drug 50 years ago, is safe, effective and easy to use for women of all ages – and that over-the-counter availability is badly needed to bring down the country’s high rate of unwanted pregnancies.
In contrast, FDA scientists questioned the reliability of company data that was supposed to show consumers would take the pill at around the same time each day and follow directions to refrain from sex or temporarily use other birth control pills when missing a dose have forgotten. The agency seemed particularly concerned about whether women with breast cancer or unexplained vaginal bleeding would make proper choices not to take Opill, and whether teens and people with limited literacy skills would use it properly.
“I’m just really quite confused about the extent of the discrepancy,” said an advisory panel member, Pamela Shaw, a senior investigator at Kaiser Permanente Washington, after both sides made presentations.
On Wednesday, the panel will take 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 an over-the-counter pill available to all ages has garnered a wave of support from reproductive and adolescent health specialists and groups like 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 institute KFF, more than three quarters of women of childbearing age favored an over-the-counter pill, primarily for reasons of convenience.
Notably, at a time of fierce controversy over abortion, including abortion pills, many anti-abortion groups have declined to criticize over-the-counter birth control. Resistance seems to come mainly from some 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 portion of the hearing.
“As a teenager, I was told by my doctor not to start birth control pills because it would make me more likely to become 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 the ‘mini-pill’ because it only contains one hormone, progestin, unlike ‘combination pills’, which contain both progestin and oestrogen.
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 are safe and about 93 percent effective at preventing pregnancy in typical use.
He said that compared to progestin-only pills, more conditions would preclude women from taking combination pills, which work by blocking the release of eggs from the ovaries and put some women at risk of blood clots.
Only progestogen pills, which thicken cervical mucus to make it harder for sperm to fertilize eggs and can also interfere with egg release, have virtually no risk of causing blood clots. Data suggests it may be more important to take progestin-only pills within the same three-hour time span each day, while combination pills allow for slightly more flexibility, he said.
dr Pamela Horn, director of an FDA non-prescription drug division, said Tuesday that she “cares about women’s health” and “would like to have clear data” to support the proposal.
However, she said there were numerous concerns and concluded that “the evidence presented by the applicant on the likelihood of efficacy 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 were given, a phenomenon called “overreporting” or “unlikely dosing.” dr Jeena Jacob, an FDA physician, said this raised concerns about these participants, as well as the possibility that “other participants who are not part of the unlikely dosing group may have misused or misreported the use.”
and dr Karen Murry, deputy director of the agency’s Office of Non-Prescription Drugs, pushed back on a much-cited figure that over 100 countries have over-the-counter pills. She said that in most of these countries, pharmacists dispense such pills, so Americans’ experiences may be different. Here she said, “If this product is approved, people could get it at a pharmacy, but they could also get it at a gas station or a big department store with no medical professionals around.”
Presentations in support of the company painted a very different picture.
“Despite the availability of a variety of birth control methods, nearly half of pregnancies each year are unintended,” said Dr. Carolyn Westhoff, an obstetrician-gynecologist at Columbia University’s Mailman School of Public Health. Noting that other over-the-counter methods, such as condoms, are less effective than the pill, she added, “We need more effective methods that are available without a prescription.”
dr Westhoff suggested that there is no benefit for most women from a doctor prescribing the pills, as doctors do not typically monitor patient compliance and often only see such patients once a year. She said it was particularly important to make the pill accessible to young people as “these youngest women faced the greatest barriers to accessing the more effective methods”.
Other speakers, including some who spoke during the public comment session, emphasized that the product would also be helpful to women in low-income, rural and marginalized communities who don’t have insurance or who find it difficult to see a doctor for a prescription because of the use of it associated time, transportation or childcare costs.
dr Pamela Goodwin, a breast cancer oncologist at Sinai Health System in Toronto, said very few breast cancer patients are at risk because their doctors advise against using it. The company’s study found that 97 percent of breast cancer patients made the right decision not to take the pill.
The study reported that participants took the pill 92.5 percent of the days they were supposed to take it, said Dr. Stephanie Sober, the US medical liaison for the company. She said nearly 85 percent of the participants took a pill at least 85 percent of the days. Most participants who missed a pill reported that they followed label directions to take mitigating measures, such as not having sex or using a condom, said Dr. Sober, adding that out of 955 participants, only six women became pregnant while taking Opill.
“Let’s face it — the instructions for using Opill are extremely simple: take one pill at the same time each day,” said Dr. Anna Glasier, a British reproductive health expert who testified for the company. “The vast majority of women have done just that. And when they made a mistake, most took appropriate mitigating action. And let’s remember that the women who missed pills often did so because they could only get a supply from the website they signed up to, whereas in the real world they could have bought a pill at any drugstore .”