An advisory committee for the US Food and Drug Administration (FDA) has unanimously endorsed the agency making an oral contraceptive available over the counter. If the FDA follows this advice, the medication, sold under the name Opill, will be the first birth control pill available without prescription in the United States. A final decision by the agency is expected in the coming months.

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Because the FDA oftentimes follows its advisers’ recommendations, the two-day meeting, ending on 10 May, was hotly anticipated. Associations such as The American College of Obstetricians and Gynecologists (ACOG) and The American Medical Association have been urging the agency to make oral contraceptives available over the counter.

“The scientific evidence is clear that over-the-counter access to contraception without age restrictions can be accomplished safely, and the benefit of increased access is significant,” said Kristyn Brandi, a gynecologist representing ACOG at the meeting. She pointed out that many people seeking contraception to prevent unwanted pregnancies face obstacles, including cost barriers and difficulties obtaining an appointment with a physician. “People from marginalized communities, including racial and ethnic minorities, uninsured people and those who don’t speak English are more likely to face these barriers,” she said.

The decision is especially important in light of recent restrictions on abortion access in the United States, says Daniel Grossman, director of Advancing New Standards in Reproductive Health (ANSIRH), a research programme at the University of California San Francisco. “People in about one-third of the country can’t access abortion care,” he says. “Now it’s even more important that remaining barriers to effective contraception are removed.”

Oral contraceptives are available over the counter in many other countries, although some require a conversation with a pharmacist. In 2021, two brands of contraceptives became available without a prescription in the United Kingdom, with only this requirement.

No prescription needed

There are two types of birth control that are based on hormones: one contains progestin, a synthetic form of the hormone progesterone, and the other uses a combination of progestin and the hormone estrogen.

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Opill, known by the generic name norgestrel, is a progestin-only medication. This type of drug has fewer risks compared with the combination pills, which have been associated with blood clots, for example. Norgestrel was first approved by the FDA in 1973. In July 2022, Opill’s maker, HRA Pharma, based in Paris, filed an application to switch the medication from requiring a prescription from a health-care provider to not needing one.

To be sold over the counter in the United States, a drug must meet certain criteria. It should be used for a condition that a user can self-diagnose — in this case, the desire to prevent an unwanted pregnancy. The user should also be able to administer the drug safely and effectively without the help of a health-care provider. With Opill, that means taking one pill every day at the same time. The last criterion is that the drug should have a low potential for misuse and abuse.

In applying for the switch to non-prescription status, HRA Pharma submitted data to the FDA from studies probing whether consumers understand how to use Opill without supervision and can correctly identify whether they have any contraindications. These are medical conditions, such as a history of breast cancer, that would preclude them from taking the drug.

Concerns raised

During the advisory meeting, FDA scientists criticized the data presented by HRA Pharma, especially the results of the study evaluating how the drug might be used in a real-world setting. About one-third of the study participants reported that they took more pills than were made available to them, which prompted the scientists to question the study’s conclusions. The scientists were also not completely convinced that users were capable of recognizing that they had contraindications for the pill.

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The agency scientists even questioned the efficacy and safety of the drug. They noted that the clinical trials that led to the medication’s approval in 1973 might have had different results if they were conducted today, citing an increased incidence of obesity that could potentially lower the efficacy of the pill.

It is unusual to bring up this issue, Grossman says. “With this kind of application to move a medication to non-prescription status, the only thing you should be looking at is whether people use it appropriately, according to the instructions and whether they can appropriately select for use or not,” he says.

The scientists’ intense scrutiny comes at a time when a lawsuit is questioning the agency’s decades-ago approval of the abortion pill mifepristone — as well as its authority. It’s unclear whether these concerns will impact the FDA’s final decision on Opill.

During the portion of the meeting when members of the public could participate, some pushed back on the concerns. “Women can understand labels, including contraindications,” said Caroline Renko, a manager at PharmedOut, a project at Georgetown University in Washington DC that educates physicians about how pharmaceutical companies influence prescribing. “Birth control pills are so commonly used that information regarding the importance of not missing doses or taking doses late is common knowledge,” she said. “These patronizing concerns are not grounds to take away a woman’s choice from her.”

During the advisory committee discussion, panellists acknowledged some of the limitations of the HRA Pharma data but ultimately concluded that enough evidence exists that the benefits of having an over-the-counter contraceptive outweigh the risks.

”Do I think that we’ve got perfect data? No,” said Cynthia Baur, a health literacy and health communication expert at the University of Maryland in College Park and advisory committee member. “Do I think it was a perfect study? No. Do I think it was adequate to feel reassured that a large number of people can use this drug as intended? Yes.”

article_text: An advisory committee for the US Food and Drug Administration (FDA) has unanimously endorsed the agency making an oral contraceptive available over the counter. If the FDA follows this advice, the medication, sold under the name Opill, will be the first birth control pill available without prescription in the United States. A final decision by the agency is expected in the coming months.

US lawsuit threatens access to abortion drug: the science behind the case

Because the FDA oftentimes follows its advisers’ recommendations, the two-day meeting, ending on 10 May, was hotly anticipated. Associations such as The American College of Obstetricians and Gynecologists (ACOG) and The American Medical Association have been urging the agency to make oral contraceptives available over the counter. “The scientific evidence is clear that over-the-counter access to contraception without age restrictions can be accomplished safely, and the benefit of increased access is significant,” said Kristyn Brandi, a gynecologist representing ACOG at the meeting. She pointed out that many people seeking contraception to prevent unwanted pregnancies face obstacles, including cost barriers and difficulties obtaining an appointment with a physician. “People from marginalized communities, including racial and ethnic minorities, uninsured people and those who don’t speak English are more likely to face these barriers,” she said. The decision is especially important in light of recent restrictions on abortion access in the United States, says Daniel Grossman, director of Advancing New Standards in Reproductive Health (ANSIRH), a research programme at the University of California San Francisco. “People in about one-third of the country can’t access abortion care,” he says. “Now it’s even more important that remaining barriers to effective contraception are removed.” Oral contraceptives are available over the counter in many other countries, although some require a conversation with a pharmacist. In 2021, two brands of contraceptives became available without a prescription in the United Kingdom, with only this requirement. There are two types of birth control that are based on hormones: one contains progestin, a synthetic form of the hormone progesterone, and the other uses a combination of progestin and the hormone estrogen.

Women’s health research lacks funding — these charts show how

Opill, known by the generic name norgestrel, is a progestin-only medication. This type of drug has fewer risks compared with the combination pills, which have been associated with blood clots, for example. Norgestrel was first approved by the FDA in 1973. In July 2022, Opill’s maker, HRA Pharma, based in Paris, filed an application to switch the medication from requiring a prescription from a health-care provider to not needing one. To be sold over the counter in the United States, a drug must meet certain criteria. It should be used for a condition that a user can self-diagnose — in this case, the desire to prevent an unwanted pregnancy. The user should also be able to administer the drug safely and effectively without the help of a health-care provider. With Opill, that means taking one pill every day at the same time. The last criterion is that the drug should have a low potential for misuse and abuse. In applying for the switch to non-prescription status, HRA Pharma submitted data to the FDA from studies probing whether consumers understand how to use Opill without supervision and can correctly identify whether they have any contraindications. These are medical conditions, such as a history of breast cancer, that would preclude them from taking the drug. During the advisory meeting, FDA scientists criticized the data presented by HRA Pharma, especially the results of the study evaluating how the drug might be used in a real-world setting. About one-third of the study participants reported that they took more pills than were made available to them, which prompted the scientists to question the study’s conclusions. The scientists were also not completely convinced that users were capable of recognizing that they had contraindications for the pill.

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The agency scientists even questioned the efficacy and safety of the drug. They noted that the clinical trials that led to the medication’s approval in 1973 might have had different results if they were conducted today, citing an increased incidence of obesity that could potentially lower the efficacy of the pill. It is unusual to bring up this issue, Grossman says. “With this kind of application to move a medication to non-prescription status, the only thing you should be looking at is whether people use it appropriately, according to the instructions and whether they can appropriately select for use or not,” he says. The scientists’ intense scrutiny comes at a time when a lawsuit is questioning the agency’s decades-ago approval of the abortion pill mifepristone — as well as its authority. It’s unclear whether these concerns will impact the FDA’s final decision on Opill. During the portion of the meeting when members of the public could participate, some pushed back on the concerns. “Women can understand labels, including contraindications,” said Caroline Renko, a manager at PharmedOut, a project at Georgetown University in Washington DC that educates physicians about how pharmaceutical companies influence prescribing. “Birth control pills are so commonly used that information regarding the importance of not missing doses or taking doses late is common knowledge,” she said. “These patronizing concerns are not grounds to take away a woman’s choice from her.” During the advisory committee discussion, panellists acknowledged some of the limitations of the HRA Pharma data but ultimately concluded that enough evidence exists that the benefits of having an over-the-counter contraceptive outweigh the risks. ”Do I think that we’ve got perfect data? No,” said Cynthia Baur, a health literacy and health communication expert at the University of Maryland in College Park and advisory committee member. “Do I think it was a perfect study? No. Do I think it was adequate to feel reassured that a large number of people can use this drug as intended? Yes.” vocabulary:

{'advisory': '顾问委员会：一个由专家组成的委员会，负责就某一特定问题提出建议', 'contraceptive': '避孕药：一种用于预防怀孕的药物', 'contraindications': '禁忌：某种药物或治疗方法不适用于某种病人的情况', 'efficacy': '疗效：某种治疗方法的有效性', 'misuse': '滥用：不当使用某种物品或服务', 'obstacles': '障碍：阻碍实现某种目标的因素', 'obstetricians': '产科医生：专门从事妇产科护理的医生', 'progesterone': '孕激素：一种由女性卵巢分泌的激素，参与控制月经周期', 'progestin': '孕激素类药物：一种合成的激素，可以模拟孕激素的作用', 'marginalized': '边缘化：指社会上被忽视或被排斥的群体', 'patronizing': '居高临下：指以高高在上的态度对待他人', 'pharmacist': '药剂师：专业从事药物分析、配置、调配和技术咨询的人员', 'prescription': '处方：由医生开具的药物处方', 'probe': '探索：深入研究或调查某一问题', 'scrutiny': '仔细检查：仔细审查或审视', 'synthetic': '合成的：由人工合成的', 'unanimously': '一致同意：指所有参与者都同意某一决定', 'unwanted': '不需要的：指不需要或不想要的', 'uphold': '支持：指支持或赞同某一观点或决定'} readguide:

{'reading_guide': '本文讨论了美国食品药品监督管理局（FDA）的顾问委员会一致支持该机构在美国推出口服避孕药，以及该决定对美国堕胎访问的影响。文章指出，如果FDA按照建议采取行动，以Opill为商品名称出售的药物将成为美国首个无需处方就可购买的避孕药。文章还指出，口服避孕药在许多其他国家已经可以在药店购买，而Opill是一种合成孕激素的单一药物，具有较少的风险。文章最后指出，尽管HRA Pharma提交的数据存在一定的局限性，但顾问委员会最终认为，拥有无处方避孕药的好处大于风险。'} long_sentences:

{'sentence 1': 'During the advisory committee discussion, panellists acknowledged some of the limitations of the HRA Pharma data but ultimately concluded that enough evidence exists that the benefits of having an over-the-counter contraceptive outweigh the risks.', 'sentence 2': 'It is unusual to bring up this issue, Grossman says. “With this kind of application to move a medication to non-prescription status, the only thing you should be looking at is whether people use it appropriately, according to the instructions and whether they can appropriately select for use or not,” he says.'}

Sentence 1: 在顾问委员会的讨论中，专家们承认HRA Pharma数据存在一些局限性，但最终得出结论，即足够的证据表明，非处方避孕药的好处大于风险。

Sentence 2: 这种情况是不寻常的，Grossman说。“在申请将药物转换为非处方药时，我们只应该看看人们是否按照说明正确使用，以及他们是否能够正确选择使用，”他说。