F.D.A. Advisers Weigh Allowing First U.S. Over-the-Counter Birth Control Pill

It was like a tale of two birth control pills.

At a hearing Tuesday, a panel of independent medical experts advising the Food and Drug Administration to consider whether it should approve the country’s first over-the-counter oral contraceptive, said two of a drug called opil. I had to take into account conflicting analyses.

During the eight-hour session, HRA Pharma, the maker of the pills owned by Perrigo, representatives from a number of medical organizations and reproductive health experts said the data strongly supported the approval. Approved as a prescription drug 50 years ago, Opil is safe, effective, easy to use appropriately by women of all ages, and available over-the-counter to reduce the country’s high rate of unwanted pregnancy. desperately needed.

In contrast, FDA scientists have shown that consumers follow instructions to take the pill at about the same time each day and abstain from sex if they miss a dose, or use other contraceptives temporarily. The agency questioned whether women with breast cancer or unexplained vaginal bleeding correctly chose not to take opil, whether adolescents and literacy A limited number of people seemed to be particularly concerned about whether opil would be used correctly.

Pamela Shaw, a senior researcher at Kaiser Permanente Washington and one of its advisory board members, said after the two presentations:

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

The move to make prescription-free pills available to all age groups has prompted reproductive health and adolescent health experts and American Medical Association, American College of Obstetricians and Gynecologists and American College of Family Medicine.

and A study by the health care research institute KFFMore than three-quarters of women of reproductive age preferred over-the-counter medications primarily for convenience.

Surprisingly, in an era of violent divisions over abortion, including abortion drugs, many anti-abortion groups refuse to criticize over-the-counter contraception. And it seems. Most of the hundreds of comments submitted before Tuesday’s hearing, and most of her 37 people who spoke during the Public He comment portion of the hearing, expressed their support.

“When I was a teenager, my doctor told me I shouldn’t start taking birth control pills because it made me more likely to be sexually active,” says 20-year-old college sophomore Rebecca Heimbrock. “Of course, we know this isn’t true. Young people who don’t have access to contraception are just having sex without it.”

Opil is called a “mini-pill” because it contains only one hormone, progestin, as opposed to the “combination” pill, which contains both progestin and estrogen.

Daniel Grossman, Ph.D., professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco, spoke in public comment Tuesday in support of the over-the-counter efforts, saying both types of pills are safe, with about 93 Percent effective in preventing pregnancy with regular use.

He suggests that more medical conditions cause women to take combination tablets that work by blocking the release of eggs from the ovaries, with the risk of causing blood clots in some women, compared to progestin-only tablets. He said it would prevent him from taking it.

Progestin-only tablets may also thicken cervical mucus making it difficult for sperm to fertilize an egg and interfere with egg release, but there is virtually no risk of causing blood clots. It may be more important to take the tablets within the same three hours each day, he said, but combination tablets are somewhat more flexible.

“We care deeply about women’s health,” Dr. Pamela Horne, director of the FDA’s non-prescription medicines division, said Tuesday, adding that she wanted “clear data” to support the application.

However, she said she had many concerns, concluding that “applicant-provided evidence regarding its potential efficacy in the non-prescription setting is mixed and has many limitations.”

The FDA highlighted the fact that about 30% of study participants reported taking more pills than they received. This is a phenomenon called “overreporting” or “improbable dosing”. FDA medical officer Dr. Gina Jacob expressed concern about these participants and that “other participants who were not part of the unlikely medication group had misused or misreported use.” It’s possible,” he said.

And Dr. Karen Murry, FDA’s Deputy Director of Non-Prescription Pharmacy, refuted the oft-cited figure that more than 100 countries have over-the-counter drugs. She said the American experience may be different, as pharmacists dispense such pills in most of those countries. People may be able to get it at pharmacies, but they may also be able to get it at gas stations and big box stores without healthcare professionals.”

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

“Each year, nearly half of all pregnancies are unintended, despite the wide variety of contraceptive methods available,” testified Dr. Carolyn Westhoff, an obstetrician and 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 methods that are available without a prescription.”

Dr. Westhoff suggested that for most women there is no benefit for doctors to prescribe the pill. Physicians do not usually monitor patient compliance, and such patients often see her only once a year. Making the pill available to adolescents is particularly important, she said, because “these youngest women faced the most significant barriers to accessing more effective methods.” I said there is.

Other speakers, including one who spoke out during the public comment session, felt that the product could be used by low-income, rural, and marginalized people who do not have insurance or who find it difficult to see a doctor to get a prescription. Emphasized that it will also help women in the affected communities. Because it takes time, transportation expenses, and childcare expenses.

Dr. Pamela Goodwin, a breast cancer oncologist at the Sinai Health System in Toronto, testified that few breast cancer patients are at risk because physicians with breast cancer advise against using it. A study by the company found that 97% of her breast cancer patients correctly chose not to take the pill.

The study reported that participants were on the pill 92.5% of the days they were scheduled. She said nearly 85% of participants took the pill at least 85% of the time. Most participants who missed their pills reported taking mitigating measures, such as abstaining from sex or using condoms, according to label instructions, and Dr. She added that she was the only woman pregnant with six.

“Honestly, Opill is very easy to use. Just take one pill at the same time each day,” said Dr Anna Glasier, a UK reproductive health expert who testified for the company. increase. “The vast majority of women did just that, and when they made a mistake, most took appropriate mitigation measures. Remember that women who missed their pills often did so because they could only get supplies from the site they signed up for.”