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Drug Company Seeks to Sell Birth Control in Stores

A drug company has asked the United States Food and Drug Administration (FDA) for permission to sell a birth control medicine "over the counter." That means it can be bought without providing a doctor's order, or prescription¹.

HRA Pharma, a French company, sent the FDA a written request Monday.

HRA's hormone²-based drug comes in pill form and prevents pregnancy³. Such contraceptive medicine was introduced in the 1960's and has become the most common form of birth control for women in the U.S. But, it has always required a prescription for purchase. The pill can lead to blood clots⁵ in some users, although this is rare.

HRA's request to the FDA argues that users can measure the risks on their own and use the pill successfully.

"For a product that has been available for the last 50 years, that has been used safely by millions of women, we thought it was time to make it more available," said Frederique Welgryn, HRA's chief strategy officer.

The HRA medicine is called Opill and is not sold in the U.S. The FDA could approve it for sale by next year. Many women's health and reproductive rights supporters want other prescription contraceptives and abortion⁶ pills to make the move to over-the-counter.

The FDA action could guide many other decisions about women's health care in the years to come. Reproductive freedom is a major issue in the country. Last month, the U.S. Supreme⁷ Court overturned Roe⁸ v. Wade⁹, the 1973 decision that established the constitutional right to seek medical abortions¹⁰.

In 2006, the FDA approved the emergency contraceptive pill, called Plan B. The medicine, progestin, prevents ovulation from taking place. It does not end an established pregnancy. Last year, the agency removed other limits on mifepristone, permitting patients to get the medication by mail after meeting with a doctor virtually. The medicine, mifepristone, blocks the body from producing a substance needed to maintain pregnancy.

Abortion opponents disagreed with those decisions.

Democratic Party lawmakers were urging the FDA to consider over-the-counter contraceptive requests even before HRA's announcement on Monday.

In a letter from March, 50 members of the House of Representatives' Pro-Choice Caucus¹¹ called on the FDA to consider over the counter birth control pills "without delay and based solely¹² on the data."

Many of America's common over-the-counter medications were once prescription-only drugs, including some pain and allergy¹³ medicine. For each medication that made the change, drug companies had to show that users understand the labeling on the bottle, can judge the risks, and can not only use it safely, but effectively without medical care from a doctor.

HRA's research includes seven years of FDA-required studies and a drug trial of 1,000 women.

Over-the-counter birth control pills are available around the world, including countries in South America, Asia, Africa, and Europe.

HRA's drug was of special interest to women's health advocates because they say the pill has fewer safety issues than other similar medicine. This is because the majority of other birth control pills contain a combination of the body substances progestin and estrogen. The estrogen can make women's monthly periods lighter¹⁴, shorter and consistent in timing¹⁵.

But estrogen can also increase the risk of blood clots, especially in women who may have heart problems, who smoke and are over the age of 35. The progestin-only pill is advised for use in people who may be at higher risk for blood clots.

HRA received financing for its research through The Oral Contraceptive Over-the-Counter Working Group. This 20-year-old group includes women's health researchers and advocates. They want to make contraceptives easy to get.

Kelly Blanchard is the president of Ibis Reproductive Health, a group member that supports increased availability of abortion and contraception. She said, "A lot of our research has been about making the case to help inspire and support a company to take this work on."

Many medical groups, including the American College of Obstetricians and Gynecologists and the American Medical Association support over-the-counter contraception.

But some groups like the nonprofit National Center for Health Research disagrees. They say that the safety risks of possible deadly blot¹⁶ clots are not worth the benefits.

The FDA continues to examine the safety of birth control pills. Last year, the FDA placed a hold on a study of over-the-counter contraception by Cadence¹⁷ Health, another drugmaker. It said Cadence needed to expand blood pressure checks on study subjects.

Before the FDA approves HRA's application, it requires a public meeting to consider the safety concerns and the overall request.

A decision is likely to come in the beginning of 2023, HRA leaders said.

Supporters like Blanchard hope that pill will be the first of many to be approved. "Once we see the approval of this product, it will demonstrate that it's possible and that the data is strong. Hopefully, we'll see the process speed up from here," Blanchard said.

Words in This Story

hormone – n. a natural substance that is produced in the body and that influences the way the body grows or develops

contraceptive – adj. or n. able to prevent a woman from becoming pregnant; a drug or device such as birth control pills or a condom that is used to prevent a woman from becoming pregnant

blood clot⁴ –n. a mass of dried blood that stops the flow of blood in the body and that can cause serious health problems

strategy – n. a detailed¹⁸ plan for achieving success in situations such as war, politics, business, industry, etc.

abortion — n. a medical procedure used to end a pregnancy and cause the death of the fetus¹⁹

ovulation — n. the time during a women's cycle when the body releases an egg for fertilization

virtually – adv. to describe something that can be done or seen using computers or the internet instead of happening in a physical placeMaintain

allergies²⁰ – n. the body's reaction to something that it is sensitive to

consistent – adj. always behaving in a similar way

inspire – v. to move (someone) to act, create, or feel emotions

1 prescription   

n.处方，开药；指示，规定

参考例句：

• The physician made a prescription against sea- sickness for him.医生给他开了个治晕船的药方。
• The drug is available on prescription only.这种药只能凭处方购买。

2 hormone   

n.荷尔蒙，激素，内分泌

参考例句：

• Hormone implants are used as growth boosters.激素植入物被用作生长辅助剂。
• This hormone interacts closely with other hormones in the body.这种荷尔蒙与体內其他荷尔蒙紧密地相互作用。

3 pregnancy   

n.怀孕，怀孕期

参考例句：

• Early pregnancy is often accompanied by nausea.怀孕早期常有恶心的现象。
• Smoking during pregnancy increases the risk of miscarriage.怀孕期吸烟会增加流产的危险。

4 clot   

n.凝块；v.使凝成块

参考例句：

• Platelets are one of the components required to make blood clot.血小板是血液凝固的必须成分之一。
• The patient's blood refused to clot.病人的血液无法凝结。

5 clots   

n.凝块( clot的名词复数 )；血块；蠢人；傻瓜v.凝固( clot的第三人称单数 )

参考例句：

• When you cut yourself, blood clots and forms a scab. 你割破了，血会凝固、结痂。 来自《简明英汉词典》
• Milk clots when it turns sour. 奶变酸就凝块。 来自《现代英汉综合大词典》

6 abortion   

n.流产，堕胎

参考例句：

• She had an abortion at the women's health clinic.她在妇女保健医院做了流产手术。
• A number of considerations have led her to have a wilful abortion.多种考虑使她执意堕胎。

7 supreme   

adj.极度的，最重要的；至高的，最高的

参考例句：

• It was the supreme moment in his life.那是他一生中最重要的时刻。
• He handed up the indictment to the supreme court.他把起诉书送交最高法院。

8 roe   

n.鱼卵；獐鹿

参考例句：

• We will serve smoked cod's roe at the dinner.宴会上我们将上一道熏鳕鱼子。
• I'll scramble some eggs with roe?我用鱼籽炒几个鸡蛋好吗？

9 wade   

v.跋涉，涉水；n.跋涉

参考例句：

• We had to wade through the river to the opposite bank.我们只好涉水过河到对岸。
• We cannot but wade across the river.我们只好趟水过去。

10 abortions   

n.小产( abortion的名词复数 )；小产胎儿；（计划）等中止或夭折；败育

参考例句：

• The Venerable Master: By not having abortions, by not killing living beings. 上人：不堕胎、不杀生。 来自互联网
• Conclusion Chromosome abnormality is one of the causes of spontaneous abortions. 结论：染色体异常是导致反复自然流产的原因之一。 来自互联网

11 caucus   

n.秘密会议；干部会议；v.（参加）干部开会议

参考例句：

• This multi-staged caucus takes several months.这个多级会议常常历时好几个月。
• It kept the Democratic caucus from fragmenting.它也使得民主党的核心小组避免了土崩瓦解的危险。

12 solely   

adv.仅仅，唯一地

参考例句：

• Success should not be measured solely by educational achievement.成功与否不应只用学业成绩来衡量。
• The town depends almost solely on the tourist trade.这座城市几乎完全靠旅游业维持。

13 allergy   

n.(因食物、药物等而引起的)过敏症

参考例句：

• He developed an allergy to pollen.他对花粉过敏。
• The patient had an allergy to penicillin.该患者对青霉素过敏。

14 lighter   

n.打火机，点火器；驳船；v.用驳船运送；light的比较级

参考例句：

• The portrait was touched up so as to make it lighter.这张画经过润色，色调明朗了一些。
• The lighter works off the car battery.引燃器利用汽车蓄电池打火。

15 timing   

n.时间安排，时间选择

参考例句：

• The timing of the meeting is not convenient.会议的时间安排不合适。
• The timing of our statement is very opportune.我们发表声明选择的时机很恰当。

16 blot   

vt.弄脏（用吸墨纸）吸干；n.污点，污渍

参考例句：

• That new factory is a blot on the landscape.那新建的工厂破坏了此地的景色。
• The crime he committed is a blot on his record.他犯的罪是他的履历中的一个污点。

17 cadence   

n.（说话声调的）抑扬顿挫

参考例句：

• He delivered his words in slow,measured cadences.他讲话缓慢而抑扬顿挫、把握有度。
• He liked the relaxed cadence of his retired life.他喜欢退休生活的悠闲的节奏。

18 detailed   

adj.详细的，详尽的，极注意细节的，完全的

参考例句：

• He had made a detailed study of the terrain.他对地形作了缜密的研究。
• A detailed list of our publications is available on request.我们的出版物有一份详细的目录备索。

19 fetus   

n.胎，胎儿

参考例句：

• In the fetus,blood cells are formed in different sites at different ages.胎儿的血细胞在不同时期生成在不同的部位。
• No one knows why a fetus is not automatically rejected by the mother's immune system. 没有人知道为什么母亲的免疫系统不会自动排斥胎儿。

20 allergies   

n.[医]过敏症；[口]厌恶，反感；（对食物、花粉、虫咬等的）过敏症( allergy的名词复数 )；变态反应，变应性

参考例句：

• Food allergies can result in an enormous variety of different symptoms. 食物过敏会引发很多不同的症状。 来自辞典例句
• Let us, however, examine one of the most common allergies; hayfever. 现在让我们来看看最常见的变态反应的一种--枯草热。 来自辞典例句