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It was like a story of two pills.
At a hearing Tuesday to consider whether the Food and Drug Administration should authorize the nation’s first over-the-counter birth control pill, a panel of independent medical experts advising the agency was left with two contrasting analyzes of the drug called Opill.
During the eight-hour session, the pill’s manufacturer, HRA Pharma, which is owned by Perrigo, and representatives of several medical organizations and reproductive health professionals said the data strongly supports approval. They said Opill, which was approved as a prescription drug 50 years ago, was appropriately safe, effective and easy to use for women of all ages — and that over-the-counter availability was badly needed to lower the country’s high rate of unwanted pregnancy.
In contrast, FDA scientists have questioned the reliability of the company’s data that was intended to show consumers would take their birth control pills at around the same time each day and adhere to directions to abstain from sex or temporarily use other contraceptives if they miss a dose. The agency seemed particularly concerned about whether women with breast cancer or unexplained vaginal bleeding would correctly choose not to take Opil and whether teenagers and people with limited literacy would use it accurately.
“I’m confused by the level of discrepancy,” said one of the advisory committee members, Pamela Shaw, a senior investigator for Kaiser Permanente Washington, after both sides gave presentations.
On Wednesday, the committee will hold a non-binding vote on whether the risks of the over-the-counter pill will outweigh its benefits. The Food and Drug Administration is expected to make a final decision this summer.
The move to provide over-the-counter pills for all ages has been greatly supported by reproductive and adolescent health professionals and groups such as American Medical Associationthe American College of Obstetricians and Gynecologists And American Academy of Family Physicians.
in Survey by the healthcare research organization KFFMore than three-quarters of women of childbearing age prefer over-the-counter birth control pills, mainly because of the convenience.
Remarkably, at a time of fierce divisions over abortion, including the abortion pill, many anti-abortion groups have refused to criticize over-the-counter birth control. The opposition seems to come primarily from some Catholic organisations. Support was expressed in the vast majority of the hundreds of comments made before Tuesday’s hearing and by most of the 37 people who spoke during the public comment portion of the hearing.
“When I was a teenager, my doctor told me I shouldn’t start the pill because it would make me more susceptible to sexual activity,” said one of the speakers, Rebecca Heimbrook, a 20-year-old college student. “Of course we know this isn’t true, and young people who don’t have access to contraception are simply having sex without using contraceptives.”
Opill is called a “mini-pill” because it contains only one hormone, progestin, unlike “combined” pills, which contain both progestin and estrogen.
Both types of pill are safe and about 93 percent effective in preventing pregnancy with typical use, said Dr. Daniel Grossman, a professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco, who spoke in support of the over-the-counter effort in public comments Tuesday. .
Compared with progestin-only pills, he said, more medical conditions will prevent women from taking the combination pill, which works by preventing the release of eggs from the ovaries and carries a risk of causing blood clots for some women.
Progestin-only pills, which thicken cervical mucus and make it more difficult for sperm to fertilize eggs, and may also disrupt the release of eggs, have no risk of causing blood clots. He noted that the data suggests that it may be important to take progestin-only pills in the same three-hour period each day, while combination pills allow somewhat greater flexibility.
Dr. Pamela Horn, the FDA’s director of nonprescription drugs, said Tuesday that she “cares deeply about women’s health” and would like “unequivocal data” to support the app.
But she said there are many concerns, concluding, “The evidence for potential for efficacy in the applicant’s over-the-counter 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 “underdosing.” That raised concerns about those participants as well as the possibility that “other participants who are not part of the unlikely dose group may have used incorrectly or incorrectly reported use,” said Dr. Gina Jacob, the FDA’s medical officer.
Dr. Karen Morey, deputy director of the agency’s Office of Non-Prescription Drugs, also chimed in on the oft-cited number that more than 100 countries have over-the-counter pills. Pharmacists dispense such pills in most of those countries, she said, so Americans’ experience may be different. Here, she said, “If this product is approved, people may get it at a pharmacy, but they may also get it at a gas station or a supermarket that doesn’t have healthcare professionals.”
Presentations supporting the company made a completely different case.
“Despite the availability of a variety of contraceptive methods, nearly half of all pregnancies are unintended each year,” said Dr. Caroline 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 birth control pills and added, “We need more effective methods to be available over the counter.”
And Dr. Westhoff suggested that for most women, there is no point in having a doctor prescribe the pills because doctors don’t usually monitor patient adherence and often only see these patients once a year. She said it was particularly important to make the pill available to adolescents because “these youngest women faced the most significant barriers to accessing the most effective methods”.
Other speakers, including some who spoke during the public comment session, emphasized that the product would also be beneficial for women in low-income, rural, and marginalized communities who do not have insurance or who find it difficult to see a doctor for a prescription because of the time, transportation, or child care costs involved. .
Dr. Pamela Goodwin, a breast cancer oncologist at Sinai Health System in Toronto, has witnessed that very few breast cancer patients are at risk because their doctors 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 stated that the participants took the pill on 92.5 percent of the days they were supposed to take it, Dr. Stephanie Soper, the company’s US medical coordinator. She said nearly 85 percent of the participants took pills on at least 85 percent of the days. Most of the participants who missed the pill reported that they followed label directions to take mitigating steps such as abstaining from sex or using a condom, said Dr. Sober, adding that of the 955 participants, only six women became pregnant while using Opill.
“Let’s face it – the instructions for using Opill are very simple: take one pill at the same time every day,” said Dr. Anna Glacier, a British reproductive health expert who testified on behalf of the company. “The vast majority of women did just that. And if they made a mistake, most took the appropriate action to mitigate. And let’s remember, women who missed their pills often did so because they could only get supplies from the location where they signed up, whereas in the real-world situation They could buy contraceptive pills at any pharmacy.
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