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FDA advisers back making birth control pill available over the counter [1]

['Laurie Mcginley', 'Rachel Roubein']

Date: 2023-05-10

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Advisers to the Food and Drug Administration on Wednesday unanimously endorsed making birth control pills available without a prescription, overriding concerns raised by the agency about whether the medication could be used in a safe and effective manner without physician oversight. Wp Get the full experience. Choose your plan ArrowRight The FDA’s outside experts expressed confidence, in a 17-0 vote, that consumers could use an oral contraceptive called Opill correctly. They said the benefits of over-the-counter status, such as increased access to contraception, outweighed the risks, including a potential lack of adherence to daily pill-taking that could result in unintended pregnancies.

The move sharply bolsters the likelihood that Opill, made by HRA Pharma, which is owned by the consumer health giant Perrigo, will become the first birth control pill available in the United States without a prescription. The FDA does not have to follow the guidance of its advisers, but a rejection of the OTC application — especially given the committee’s view — would be awkward for an administration that has repeatedly pledged to protect reproductive rights following the Supreme Court’s overturning of Roe v. Wade, which guaranteed the nationwide right to abortion.

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“I think this represents a landmark in our history of women’s health,” Margery Gass, a member of the advisory committee and an emerita professor at the University of Cincinnati College of Medicine, said after the vote. Several panel members said they were moved by pleas from several women for improved availability of birth control pills during a public comment session Tuesday.

Still, FDA staffers, at the advisory committee meetings Tuesday and Wednesday, flagged concerns, including whether some women with breast cancer or some other medical conditions would correctly recognize that they should not take the medication. And the staffers raised questions about the reliability of the company’s data and faulted it for not including a greater number of younger adolescents in its studies.

At times, the panel sessions seemed like a high-stakes tennis match, with the company and the FDA volleying on their differing interpretations of studies testing how consumers used Opill.

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In the end, the outside experts showed strong support for allowing the progestin-only Opill to be sold over the counter. Several said that whether a woman follows directions to take Opill in the same three-hour window daily does not depend on whether she gets it with a prescription.

“Whether somebody takes it exactly correctly, whether they miss some, that happens all the time” in the prescription setting, said committee member Leslie Walker-Harding, chair of the pediatrics department at the University of Washington. Talking to adolescents in a doctor’s office for 20 minutes and giving them a one-year prescription is probably the same as their reading an OTC label, she said.

Katalin E. Roth, a member of the panel who is a professor of medicine at George Washington University School of Medicine & Health Sciences, said providing access to people who face barriers getting contraception was her overriding consideration. “We know there’s a need,” Roth said, adding she believes the safety profile of Opill is “very well established.”

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The committee action was applauded by reproductive health advocates, who are pressing hard for approval of an OTC pill. They say some of the biggest beneficiaries of a nonprescription pill would be medically underserved groups, including people of color, adolescents and residents of rural communities.

The prospect of an OTC pill has not set off political and legal battles akin to those ignited by one of the abortion drugs, mifepristone, which is the target of a lawsuit by antiabortion medical organizations and doctors. Several antiabortion groups, asked about over-the-counter birth control, said their focus remains on abortion and on mifepristone.

Opill, known generically as norgestrel, was approved in 1973 under a different name as a prescription product, but taken off the market years ago for business reasons. Its active ingredient is progestin, a synthetic form of the natural hormone progesterone.

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The FDA’s decision on the proposed OTC Opill is expected this summer or early fall. The ruling would not affect other birth control pills, but an approval might encourage other companies to seek nonprescription status, some supporters say.

The agency’s outside experts — a group composed of the agency’s nonprescription drug advisory committee and its obstetrics, reproductive and urologic drugs panel — spent Tuesday and much of Wednesday considering the matter.

Perrigo officials, who are seeking OTC status with no age restrictions, said millions of women have taken birth control pills for decades, proving them safe and effective. The company said its studies involving Opill showed that consumers, including adolescents, could understand important information on the label, including who should take the drug — and who should not.

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But FDA reviewers interpreted some of the company data differently and concluded that the “evidence of likelihood of effectiveness in nonprescription setting is mixed and limited” — in part because women are heavier than they were when the progestin-only pill was approved in 1973, and there are not definitive studies showing whether the weight change reduces the drug’s effectiveness. They also worried that people who missed a pill might not understand they should temporarily use other contraceptives or abstain from sex.

The FDA also was concerned that almost one-third of participants in the company’s “actual use” study reported taking more pills than they could have possessed. Agency officials said the magnitude of the overreporting raised questions about the reliability of the company’s other data.

“I can’t think of a study that had 30 percent invalid data,” said Theresa Michele, director of the FDA’s Office of Nonprescription Drugs. “We are left with this ambiguity.”

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Perrigo officials countered that they commissioned a third-party analysis to assess the “root cause” of the overreporting issue. The company said the analysis did not come up with a clear answer but ruled out a systemic problem that suggested the other data were unreliable. The company also said another of its studies showed that 97 percent of women with breast cancer, or a history of it, correctly decided against using Opill.

The advisory committee members said they did not think the FDA should require another study to resolve questions about the data.

“Do I think we got perfect data? No,” said Cynthia Baur, director of the Horowitz Center for Health Literacy at the University of Maryland School of Public Health. But she added: “Do I think it was adequate to feel that a large number of people can use this drug as intended? Yes.”

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Near the end of the meeting, Karen Minerve Murry, deputy director of the FDA’s Office of Nonprescription Drugs, said that the agency recognized the importance of improved access to contraception but that the company had put the agency in a difficult position by submitting data that was difficult to interpret.

Medical groups, including the American College of Obstetricians and Gynecologists and the American Medical Association, have endorsed an OTC birth control pill. During the open hearing portion of the committee meeting Tuesday, several representatives of reproductive health groups called for approval of OTC status for Opill.

“Bringing the pill over the counter is an important step forward,” Nicole Martin, director of political education for the nonprofit Indigenous Women Rising, a reproductive rights group, said during the hearing Tuesday.

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The FDA approved the first birth control pill in 1960, igniting sexual and economic revolutions that changed American life. But the agency has never cleared a daily contraceptive for OTC sale. Birth control pills are available in more than 100 countries without a doctor’s prescription, but the FDA said that many of those countries require pharmacists to write prescriptions and counsel customers.

Contraceptive methods available over the counter include condoms and spermicides, which are not as effective as prescription birth control pills at preventing pregnancy.

There are two main kinds of birth control pills. One contains only progestin, like Opill, which works by thickening cervical mucus to inhibit sperm and suppressing ovulation. The other contains progestin and a synthetic version of the hormone estrogen. Combination pills are far more popular in the United States than the progestin-only tablets, but there are also more medical conditions that rule out use of those pills.

HRA Pharma acquired Opill in 2014 with the intention of selling it OTC. It has been working closely with Ibis Reproductive Health, a Cambridge, Mass., research group that heads Free the Pill, a coalition of dozens of groups seeking nonprescription status for the medication.

Almost half of U.S. pregnancies are unintended, according to a new study by the Guttmacher Institute, a research organization that supports reproductive rights. Experts say the percentage is much higher among adolescents.

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[1] Url: https://www.washingtonpost.com/health/2023/05/10/birth-control-pill-over-the-counter-fda/

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