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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 to consider whether the Food and Drug Administration should authorize the country’s first over-the-counter birth control pill, a panel of independent medical experts advising the agency was left to reckon with two contradictory analyses of the medication called Opill.

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

In contrast, F.D.A. scientists questioned the reliability of company data that was intended to show that consumers would take the pill at roughly the same time every day and comply with directions to abstain from sex or temporarily use other birth control if they missed a dose. The agency seemed especially concerned about whether women with breast cancer or unexplained vaginal bleeding would correctly choose not to take Opill and whether adolescents and people with limited literacy would use it accurately.

“I’m just really quite confused by the level of discrepancy,” one member of the advisory panel, Pamela Shaw, a senior investigator with Kaiser Permanente Washington, said after both sides had made presentations.

On Wednesday, the panel will take a nonbinding vote on whether the risks of an over-the-counter pill would outweigh its benefits. The F.D.A. is expected to make a final decision this summer.

The move to make a nonprescription pill available for all ages has garnered a groundswell of support from specialists in reproductive and adolescent health 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 care research organization KFF, more than three-quarters of women of reproductive age favored an over-the-counter pill, primarily because of convenience.

Strikingly, at a time of fierce divisions over abortion, including abortion pills, many anti-abortion groups have declined to criticize over-the-counter birth control. Opposition appears to primarily come 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 hearing’s public comment portion.

“As a teenager I was told by my doctor that I shouldn’t start the birth control pill because it would make me more likely to become sexually active,” said one speaker, Rebecca Heimbrock, a 20-year-old college sophomore. “Of course we know that this is not true, and young people without access to birth control simply have sex without being on birth control.”

Opill is called a “mini pill” because it contains only one hormone, progestin, in contrast to “combination” pills, which contain both progestin and estrogen.

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, said both types of pills were safe and about 93 percent effective in preventing pregnancy with typical use.

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

Progestin-only pills, which thicken cervical mucous to make it difficult for sperm to fertilize eggs and may also disrupt the release of eggs, have virtually no risk of causing blood clots. Data has suggested that it may be more important to take progestin-only pills within the same three-hour period each day, while combination pills allow somewhat greater flexibility, he said.

Dr. Pamela Horn, director of an F.D.A. division for nonprescription drugs, said Tuesday that she “cares deeply about women’s health” and would “love to have unambiguous data” to support the application.

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

The F.D.A. highlighted the fact that about 30 percent of study participants reported taking more pills than they had received, a phenomenon called “overreporting” or “improbable dosing.” Dr. Jeena Jacob, an F.D.A. medical officer, said that raised concerns about those participants as well as the possibility that “other participants who are not part of the improbable dosing group may have incorrectly used or incorrectly reported use.”

And Dr. Karen Murry, deputy director of the agency’s Office of Nonprescription Drugs, pushed back on a much-quoted figure that over 100 countries have over-the-counter pills. She said that pharmacists dispense such pills in most of those countries, so Americans’ experience might be different. Here, she said, “if this product is approved, people might get it in a pharmacy, but they also might get it in a gas station or a big box store with no health care professionals around.”

Presentations supporting the company made a very different case.

“Despite availability of a variety of contraceptive methods, nearly half of the pregnancies are unintended every year,” Dr. Carolyn Westhoff, an obstetrician-gynecologist at Columbia University’s Mailman School of Public Health, testified. She noted that other over-the-counter methods, such as condoms, were less effective than the pill and added, “We need more effective methods to be available without a prescription.”

Dr. Westhoff suggested that for most women, there is no advantage to a doctor prescribing the pills because doctors don’t typically monitor patient adherence and often only see such patients once a year. She said it was especially important to make the pill available to adolescents because “these youngest women faced 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 be helpful for women in low-income, rural and marginalized communities who didn’t have insurance or who found 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, testified that very few breast cancer patients would be at risk, because their doctors would advise them against using it. The company’s study found that 97 percent of breast cancer patients correctly opted not to take the pill.

The study reported that participants had taken the pill on 92.5 percent of the days they were supposed to take it, Dr. Stephanie Sober, the U.S. medical liaison for the company. She said that nearly 85 percent of participants had taken a pill on at least 85 percent of the days. Most participants who missed a pill reported that they had followed the label’s directions to take mitigating steps such as abstaining from sex or using a condom, Dr. Sober said, adding that among 955 participants, only six women had become pregnant while using Opill.

“Let’s face it — the instructions for Opill use 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 vast majority of women did just that. And if they made a mistake, most took the appropriate mitigating action. And let’s remember that the women who did miss pills often did so because they could only get a supply from the site where they had enrolled, while in the real world situation, they could have bought a pill from any drugstore.”

Sumber: www.nytimes.com