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CNN —As the first over-the-counter birth control pill in the United States hits store shelves, the company behind the product, Perrigo, is taking steps to ensure women are aware of this new contraception option. It’s a different formulation than what is in combination hormonal birth control pills, which contain both progestin and estrogen. Combined birth control pills may carry risks for people with uncontrolled hypertension or blood clot risks for smokers older than 35. Most birth control pills are up to 99% effective at preventing pregnancy if taken as instructed. “I’m always a little skeptical of Big Pharma and their partnerships, but I think the general principle of having highly effective over-the-counter birth control be over the counter, that’s empowering” she said.
Persons: “ We’re, Opill, , Colie Edison, “ We’ve, Leila Bahbah, ” Edison, “ we’re, , , , Roe, Wade, prescribers, Joe Biden, Dobbs, Dr, Sanjay Gupta, Colleen Denny, Denny, “ I’m, ” Denny Organizations: CNN, WNBA, , ESPN, US Food and Drug Administration, Jackson, Health Organization, White, Get CNN, CNN Health, NYU Langone Hospital –, Big Pharma Locations: United States, Dobbs v,
CVS Health on Thursday said its drug plans will cover the first over-the-counter birth control pill in the U.S. at no cost for many health plan sponsors, a decision that could open the door for more people to prevent unintended pregnancies without a prescription. The company's pharmacy benefit manager, CVS Caremark, said the pill will be added to its preventive services oral contraceptives list and will be covered at zero cost for many sponsors. Pharmacy benefit managers, or PBMs, maintain lists of drugs covered by health insurance plans and negotiate drug discounts with manufacturers. It marks the first time that many U.S. residents are able to buy birth control pills over the counter, the same way they would purchase common pills like Tylenol or Advil. The drug could significantly expand availability of contraception, especially for younger women and those in rural and underserved communities who often have trouble getting access to birth control methods.
Persons: Opill, Biden, Wade Organizations: CVS, CVS Caremark, CNBC, Pharmacy, Drug Administration Locations: San Anselmo , California, U.S, Perrigo
It is the first hormonal birth control available for retail and will expand access. Prescription-free birth control will expand accessThe introduction of Opill to family planning aisles will lower barriers to birth control. Since Opill is available without a prescription, people will no longer have to pay a doctor or pharmacist to access hormonal birth control. She urged policymakers to make sure non-prescription birth control is covered by insurance and assistance programs. AdvertisementProgestin-only birth control also carries a risk of ectopic pregnancy and can increase a person's risk for breast cancer, regardless of medical history.
Persons: , Opill, Victoria Nichols, Nichols, Dr, Tania Serna Organizations: Amazon, Walgreens, CVS, Target, Walmart, Service, US Food and Drug Administration, Guttmacher, Guttmacher Institute, Affordable Care, Kaiser Family Foundation, The American College of Obstetricians, OB, University of California Locations: San Francisco
Why It MattersThe medication, called Opill, which was approved for over-the-counter sale by the Food and Drug Administration last year, will be the most effective birth control method available without a prescription, research shows — more effective than condoms, spermicides and other nonprescription methods. Some experts said they thought it might be a particularly good option for teenagers, who might otherwise rely on condoms. Reproductive health experts and members of an F.D.A. But long before that, the move to make a nonprescription pill available for all ages had received widespread support from specialists in reproductive and adolescent health and groups. In a survey in 2022 by the health care research organization KFF, more than three-quarters of women of reproductive age said they favored an over-the-counter pill, primarily because of convenience.
Persons: Lupe M, Rodriguez, ” Karen Murry, Opill Organizations: Food and Drug Administration, National Latina Institute, Reproductive
CNN —The US Food and Drug Administration has approved the oral contraceptive Opill for over-the-counter use, making it the first nonprescription birth control pill in the United States, but it will be months before it’s available. The typical combination birth control pill, the most commonly used form of oral contraception, uses both hormones to prevent pregnancy. “People use birth control for things outside of preventing pregnancy like [polycystic ovary syndrome], treating heavy periods, painful periods,” she said. “There’s a lot of uses for it outside of birth control that people also will benefit if they can get it over the counter.”Who can use Opill? This could have a major impact for adolescents and young adults who may not otherwise have the resources to access birth control, according to Brandi.
Persons: Gynecologists, ” ACOG, Carolyn Westhoff, they’re, , , Opill, Kristyn Brandi, Brandi, ” Brandi, Anne, Marie Amies Oelschlager, Amies Oelschlager, Jennifer Robinson, ” Robinson, Frederique, Joe Biden, Court’s Dobbs, Dr, Sanjay Gupta, Meg Tirrell Organizations: CNN, Food and Drug Administration, American College of Obstetricians, FDA, Columbia University, Physicians for Reproductive Health, Gynecology, of Gynecology, Johns Hopkins University, Treasury, Labor, Human, CNN Health Locations: United States, Opill, New Jersey
Like many of my colleagues, I’ve been holding my breath for the last year, since HRA Pharma, which manufactures Opill, submitted its application to the F.D.A. We now have hope that other advances could be coming to help offset restrictions on minors’ access to contraception and state-level abortion bans. under President George W. Bush approved Plan B for over-the-counter sale, but only for people 18 or older. Because of the age restriction, the product was shunted behind the pharmacy counter, where the consumer’s age could be confirmed. asked Plan B’s sponsor for additional data on people 17 and younger to show the product could be used safely and effectively by adolescents.
Persons: Roe, — Opill, I’ve, Opill, George W, Bush Organizations: Food and Drug Administration, HRA Pharma
The first birth control pill sold without a prescription in the U.S. could remain out of reach for some women and girls because health insurance plans are not required to cover the medication in its over-the-counter form. But some women and girls could still face barriers to obtain Opill. The Affordable Care Act does not require private health insurance to cover the cost of the pill when used without a prescription. Most health insurers are required to offer birth control for free when prescribed by a doctor. State Medicaid programs are also generally not required to cover drugs sold without prescription, according to the federal Centers for Medicare & Medicaid Services.
Persons: Perrigo, Frederique Welgryn, Welgryn Organizations: U.S . Food, Drug Administration, Women's Health, Perrigo, Medicare, Medicaid Services Locations: U.S
An over-the-counter pill would eliminate a lot of barriers, she said. For young people, accessing birth control can be “really challenging,” she said. The New York Times interviewed 18 women and girls about the F.D.A. “My mom does not approve of birth control” because of her more conservative Sri Lankan heritage, said Tharushi Samarasinghe, a 19-year-old student at Hunter College. “I took birth control once for hormonal issues as I was going through puberty.
Persons: greenlight, Elise Berlan, , KFF, Tharushi Samarasinghe, , ’ ” Elizabeth, I’m Organizations: Nationwide Children’s Hospital, New York Times, Hunter College Locations: United States, Columbus , Ohio, Sri Lankan
HRA Pharma expects a final decision by the FDA this summer on its application for nonprescription sales of Opill, which is generically called norgestrel. The Food and Drug Administration on Thursday approved the first over-the-counter birth control pill, a landmark decision that will allow more women and girls in the U.S. to prevent unintended pregnancies without a prescription. The daily pill, called Opill, was first approved by the FDA as a prescription in 1973. Medical organizations like the American College of Obstetricians and Gynecologists and women's health advocates have pushed for wider access. More than 50 members of Congress in March 2022 also called on FDA Commissioner Dr. Robert Califf to ensure the agency reviewed applications for over-the-counter birth control pills without delay.
Persons: Biden, Wade, , Welgryn, Robert Califf, Patrizia Cavazzoni, Opill Organizations: HRA Pharma, FDA, Drug Administration, American College of Obstetricians, FDA's Center, Drug, Research Locations: U.S, Paris, Dublin
FDA approves first over-the-counter birth control pill
  + stars: | 2023-07-13 | by ( Carma Hassan | ) edition.cnn.com   time to read: +3 min
CNN —The US Food and Drug Administration on Thursday approved the birth control pill Opill to be available over-the-counter — the first nonprescription birth control pill in the United States. Opill is expected to be available over-the-counter in stores by the end of March 2024. The FDA has faced pressure to allow Opill to go over-the-counter from lawmakers as well as health care providers. A recent study showed that it has become harder for women to access reproductive health care services more broadly — such as routine screenings and birth control — in recent years. About 45% of women experienced at least one barrier to reproductive health care services in 2021, up 10% from 2017.
Persons:  “, Patrizia Cavazzoni, , , Frederique Welgryn, Opill, Welgryn, Perrigo, Dr, Sanjay Gupta, , Meg Tirrell Organizations: CNN, Food and Drug Administration, FDA’s Center, Drug, Research, FDA, CNN Health Locations: United States, U.S
July 13 (Reuters) - The U.S. Food and Drug Administration on Thursday approved the first over-the-counter contraceptive pill, paving the way for millions of women in the country to purchase birth control without prescription. Perrigo will next week share its pricing plan for the pill, which will be available in stores and online in the first quarter of next year. Women should take a progestin-only pill within the same three hours every day to avoid pregnancy. The National Catholic Bioethics Center and other groups have opposed making Opill available without prescription, saying physicians should be involved in health decisions, especially for teenagers, along with parental supervision, to avoid harm. Perrigo gained the daily-use pill first through its $2.13 billion acquisition of Paris-based HRA Pharma in 2021.
Persons: Roe, Wade, Xavier Becerra, Opill, Jeffrey Singer, Perrigo, Manas Mishra, Sriparna Roy, Arun Koyyur Organizations: U.S . Food, Drug Administration, Perrigo, Human Services, Cato Institute, FDA, Catholic Bioethics Center, HRA Pharma, Thomson Locations: U.S, Paris, Bengaluru
The FDA approved the first over-the-counter birth control pill. Advocates pushed for expanding birth control access, especially with more restrictions on abortion. U.S. officials have approved the first over-the-counter birth control pill, which will let American women and girls buy contraceptive medication from a retail store without a prescription. But women's health advocates hope the decision will pave the way for more over-the-counter birth control options and, eventually, for abortion pills to do the same. Newer birth control pills typically combine two hormones, estrogen and progestin, which can help make periods lighter and more regular.
Persons: Perrgio's, Perrigo's, Perrigo, Opill —, Roe, Wade, Opill Organizations: FDA, Drug Administration Locations: Ireland
The Food and Drug Administration on Thursday approved a birth control pill to be sold without a prescription for the first time in the United States, a step that could significantly expand access to contraception. The medication, called Opill, will become the most effective birth control method available over the counter — more effective at preventing pregnancy than condoms, spermicides and other nonprescription methods. Experts in reproductive health said its availability could be especially useful for young women, teenagers and those who have difficulty dealing with the time, costs or logistical hurdles involved in visiting a doctor to obtain a prescription. The pill’s manufacturer, Perrigo Company, based in Dublin, said Opill would most likely become available from stores and online retailers in the United States in early 2024. The company did not say how much the medication would cost — a key question that will help determine how many people will use the pill — but Frédérique Welgryn, Perrigo’s global vice president for women’s health, said in a statement that the company was committed to making the pill “accessible and affordable to women and people of all ages.” Ms. Welgryn has also said the company would have a consumer assistance program to provide the pill at no cost to some women.
Persons: Opill, Ms, Welgryn Organizations: Drug Administration, Perrigo Locations: United States, Dublin
The first over-the-counter birth control pill has been approved by the FDA. Opill has been in use for over 50 years and has a 93% effective rate at preventing pregnancy.
Persons: Opill Organizations: FDA
Her best guess is that even though there are no legal restrictions on birth control in the US, this practice might have been anticipating some. “So we had talked about it with her before, and the decision to get birth control was really independent from the whole [end of] Roe v. Wade. There, anyone under 18 needs their parent’s permission to get birth control – even if they’re already a parent themselves. In the meantime, Title X clinics in Texas have stopped providing birth control to teens unless they get their parents’ OK. To them, she said, getting a teenager birth control was like giving her permission to have sex.
Persons: Court’s Dobbs, Christine, , , Dobbs, “ I’ve, ” “, ’ ”, you’re, you’ve, ’ “ Christine, Nobody, Christine’s, ‘ we’re, isn’t, royally, Christine said, ” Christine, Adam, “ She’s, She’s, she’s, Roe, Wade, ” Adam, what’s, she’ll, ” Adam’s, , they’re, Matthew Kacsmaryk, X, , Graci D’Amore, we’ve, there’s, Opill, Kathleen, hasn’t, ’ ” Kathleen, I’ve, Dr, Sanjay Gupta, ” Kathleen Organizations: CNN, Catholic, wouldn’t, Alliance for Hippocratic Medicine, Food, ACT, Guttmacher Institute, US Centers for Disease Control, FDA, CNN Health Locations: United States, Wisconsin, Louisiana, Texas, , Florida
An advisory panel at the Food and Drug Administration this month unanimously recommended that a contraceptive pill, Opill, be made available over the counter. At a 1992 conference on birth control, an official on the F.D.A.’s fertility and maternal health drugs advisory committee, Philip Corfman, noted that the birth control pill is safer than aspirin, which is available over the counter. subsequently announced plans to convene a hearing to consider moving oral contraceptives over-the-counter. It was believed that this would greatly expand access to birth control by bypassing doctors, to whom millions of Americans then — as still now — had little access. Dr. Prescott reported that the program director of the National Women’s Health Network at the time, Cindy Pearson, said that a “birth control prescription is the poor woman’s ticket to health care.” Advocates for women’s health were concerned that if birth control were made available over the counter, then insurance might stop paying for it and impose new financial barriers to access.
WSJ’s Daniela Hernandez explains how over-the-counter access could affect reproductive care across the U.S. Photo: Laura KammermannAs efforts to crack down on abortion increase around the U.S., contraceptives are bound to play an increasingly important role in family planning. But for many women, cost and access are still prohibitive factors. A cheaper, over-the-counter option could help close that gap while creating a sizable market for generic drugmaker Perrigo . Advisers to the Food and Drug Administration earlier this week recommended that Perrigo’s oral contraceptive, called Opill, be made available without prescription. If the recommendation is adopted by the FDA, it would help widen access to birth control around the country.
Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailPerrigo CEO Murray Kessler: Over-the-counter birth control is a 'historic opportunity for women'Murray Kessler, Perrigo President & CEO, joins 'Closing Bell Overtime' to discuss the FDA's recommendation of Opill, an over the counter birth control pill, as well as new safety measures in baby formula manufacturing.
A panel of experts who advise the Food and Drug Administration unanimously recommended Wednesday that the agency for the first time allow women to obtain a birth control pill without a prescription. The panel had been asked whether the benefits of selling HRA Pharma's birth control pill Opill outweighed the risks of consumers improperly using the medication resulting in unintended pregnancy. Medical associations such as the American College of Obstetricians and Gynecologists for years have urged over-the-counter sales of birth control pills be allowedMore than 50 members of Congress in March 2022 called on FDA Commissioner Dr. Robert Califf to ensure the agency reviewed applications for over-the-counter birth control pills without delay. "Despite decades of proven safety and effectiveness, people still face immense barriers to getting birth control due to systemic inequities in our healthcare system." Shrinking access to abortion across the U.S. in turn sparked renewed calls for expanded access to birth control to prevent unwanted pregnancies.
Food and Drug Administration advisers concluded that the benefits outweighed the risks of making a hormonal contraceptive pill — sold under the brand name Opill and produced by the French company HRA Pharma — available without a prescription. follows the nonbinding recommendation of its advisers — and there is a chance the agency might not — Opill would become the first and only birth control pill to be available over the counter since oral contraceptives were introduced in the U.S. in 1960. A 2022 survey found that 77 percent of more than 5,000 female participants favored the idea of getting the birth control pill over the counter, with many saying it would be more convenient and efficient to get it without a prescription. Progestin-only pills have been widely used in the United States since the first one was approved in 1973. Like other oral contraceptives, they require a prescription from a health care provider or, in some states, a pharmacist.
U.S. FDA advisers back OTC use of Perrigo's birth control pill
  + stars: | 2023-05-10 | by ( ) www.reuters.com   time to read: +1 min
May 10 (Reuters) - A U.S. Food and Drug Administration advisory panel on Wednesday voted in favor of using Perrigo Co's (PRGO.N) contraceptive without a prescription, paving the way for the country's first approval for an over-the-counter birth control pill. The panel remained positive on the effectiveness of the pill, not only in the general population of women but also in adolescent populations and those with limited literacy. Perrigo's Opill, currently approved for prescription use, would be the first OTC non-estrogen contraceptive pill in the United States if approved by the regulator. The FDA generally follows the advise of its experts, though it is not bound to do so. Reporting by Sriparna Roy and Nandhini Srinivasan in Bengaluru; Editing by Shailesh KuberOur Standards: The Thomson Reuters Trust Principles.
A panel of advisers to the Food and Drug Administration voted unanimously on Wednesday that the benefits of making a birth control pill available without a prescription outweigh the risks, a significant step in the decades-long push to make oral contraception obtainable over the counter in the United States. If the F.D.A. approves nonprescription sales of the medication, called Opill, this summer, it could significantly expand access to contraception, especially for young women and those who have difficulty dealing with the time, costs or logistical hurdles involved in visiting a doctor, reproductive health experts say. Approval is not a foregone conclusion, however. analysts also raised questions about whether younger adolescents and people with limited literacy could follow the directions.
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. 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. “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.
The Food and Drug Administration could approve the sale of birth control medication without a prescription for the first time by this summer. The FDA approved prescription sales of HRA Pharma's birth control pill in 1973. Medical associations such as the American College of Obstetricians and Gynecologists for years have supported over-the-counter access to birth control without age restrictions. In March 2022, more than 50 members of Congress urged FDA Commissioner Dr. Robert Califf to review applications for over-the-counter sales of birth control without delay. "Despite decades of proven safety and effectiveness, people still face immense barriers to getting birth control due to systemic inequities in our healthcare system."
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