FDA Advisers Weigh Allowing First U.S. Over-the-Counter Birth Control Pill

It was a story of two birth-control pills.

Two contradictory opinions about Opill were presented to a panel of independent experts who advise the Food and Drug Administration at a hearing on Tuesday.

During an eight-hour meeting, representatives from many medical groups and reproductive health experts said that the data strongly supported the approval. The women said Opill was a safe and effective prescription drug that was easy to use by women of any age. They also said it was available over the counter.

FDA scientists, on the other hand, questioned the validity of data from the company that claimed that users would take the pill around the same time each day and follow instructions to abstain sex if they missed their dose or use temporary birth control. The FDA was concerned that women with breast carcinoma or unexplained bleeding in the vaginal area would not take Opill correctly and that adolescents and those with low literacy skills would also use it incorrectly.

After both sides made their presentations, Pamela Shaw of Kaiser Permanente Washington said, "I'm really confused by the discrepancy."

The panel will vote non-bindingly on Wednesday to determine if the risks and benefits of a drug sold over the counter outweigh each other. The FDA will likely make a decision by the end of summer.

Specialists in reproductive and adolescent medicine, as well as groups such the American Medical Association and the American College of Obstetricians and Gynecologists and American Academy of Family Physicians have all expressed support for the move.

According to a KFF survey, over three quarters of women in reproductive age preferred an over-the counter pill primarily due to convenience.

Start optional trimming (BEGIN OPTIONAL TRISING.)

In a time when abortion is a hotly debated issue, and abortion pills are no exception, it's striking that many anti-abortion organizations have refused to criticize birth control available over the counter. Some Catholic groups seem to be the main opponents. The vast majority of hundreds who submitted comments before the hearing on Tuesday and most of those 37 people who spoke at the public comment section of the hearing expressed support.

Rebecca Heimbrock (20-year-old college freshman) said that her doctor told her as a teenager not to take the birth control pills because they would increase their chances of becoming sexually active. "Of course, we know this isn't true. Young people without birth control just have sex."


Opill is referred to as a "mini pill" because it only contains one hormone: progestin. This is in contrast with 'combination pills', which contain progestin along with estrogen.

In public comments on Tuesday, Dr. Daniel Grossman of the University of California San Francisco's Department of Obstetrics, Gynecology, and Reproductive Sciences, who spoke out in support of this over-the counter effort, stated that both types of pills are safe and 93% effective at preventing pregnancy when used as directed.

He stated that, compared to taking progestin only pills, women with more medical conditions may not be able to take combination pills. These pills work by blocking eggs from being released from the ovaries, and can cause blood clots in some women.

Blood clots are virtually nonexistent with progestin pills. They thicken the cervical mucous, making it harder for sperms to fertilize eggs. They may also interfere with egg release. He said that data suggests it is more important to take the progestin pills every day within a three-hour time frame, whereas combination pills offer greater flexibility.

Dr. Pamela Horn is the director of FDA's nonprescription drug division. She said that she was 'deeply concerned about women's healthcare' and would love to have clear data to support her application.

She said that there were many concerns and concluded that the 'evidence for likelihood of efficacy in the nonprescription settings submitted by the applicant was mixed and had many limitations'

The FDA highlighted that approximately 30% of participants in the study reported taking more pills then they received. This phenomenon is called "overreporting" or "improbable dosage." Dr. Jeena Jacob, an FDA medical officer said this raised concerns for those participants, as well as that other participants, who were not in the improbable dose group, may have used or reported incorrectly.

Start optional trimming (BEGIN OPTIONAL TRISING.)

Karen Murry is the deputy director of the Office of Nonprescription Drugs at FDA. She disputed a widely quoted statistic that more than 100 countries sell over-the counter pills. She explained that in many of these countries, pharmacists are responsible for dispensing such pills. The experience Americans may have is different. She said that if the product was approved, it could be available in a pharmacy but also in a large-box store or gas station without any health professionals present.


The presentations that supported the company presented a completely different picture.

She said that condoms and other over-the counter methods were less effective than pill contraception.

Westhoff said that doctors prescribing pills to most women would not be beneficial because they don't monitor their adherence, and see them only once a year. She said that it was important to provide the pill to teenagers because "these young women face the most significant barriers in accessing more effective methods."

Start optional trimming (Begin)

Some speakers during the public comments session also said that the product could be useful for women who live in rural, low-income communities or are marginalized. They may not have insurance, or find it difficult to visit a doctor because of time, child care or transportation costs.

Dr. Pamela Goodwin is a breast oncologist with Sinai Health System, Toronto. She testified that only a small number of breast cancer patients are at risk because their doctors will advise them not to use it. According to the study, 97% of breast-cancer patients chose correctly not to take it.


According to Dr. Stephanie Sober of the U.S. Medical Liaison for the company, the study showed that the participants took the pill on 92.5 percent of the days when they were supposed take it. She stated that almost 85% had taken the pill at least 85% days. Sober reported that most participants who missed a dose of Opill had taken the prescribed steps to mitigate their absence, such as refraining from sexual activity or using a contraceptive.

The instructions for Opill are very simple. Take one pill at the same time each day. This is what Dr. Anna Glasier said, a British expert in reproductive health who spoke for the company. The vast majority of women followed this advice. If they did make a mistake, the majority took the necessary measures to mitigate it. Let's not forget that many women who missed pills did so because the only place they could get them was the site they were enrolled at, whereas in reality, they would have been able to buy a pill anywhere.

This article was originally published in
The New York Times