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US FDA Approval of First Over-the-Counter Birth Control Pill

US FDA

A contraceptive pill will be available without a prescription for the first time in the US

Shutterstock / Image Point Fr

The first oral contraceptive tablet to get US FDA clearance for over-the-counter sale in the United States. The 13th of July’s announcement will expand the availability of birth control in the United States.

In the United States now, hormonal contraceptives are only available with a doctor’s prescription. Those without health insurance, those who live in remote places, and those who lack the time or energy to get to a clinic may find this difficult. Nearly one-third of American women who sought a new or renewed prescription for hormonal birth control in 2016 had trouble doing so, according to a poll of those women.

The Opill birth control pill, accessible without a prescription, will hit store shelves and internet marketplaces in the United States in the first few months of 2019. This clearance does not cover any other hormonal methods of birth control.

Opill was initially granted prescription-only status by the FDA in 1973. By comparison, OTC contraceptives like condoms and spermicides are only around 79 to 87 percent effective in preventing pregnancy when used as directed.

Representing the FDA, Patrizia Cavazzoni said, “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”

Nearly half of the 6.1 million annual pregnancies in the United States are unplanned, according to the Food and Drug Administration. There is a correlation between unintended pregnancies and negative mother and child health outcomes, such as prenatal and postpartum depression, domestic abuse, and premature delivery.

Opill is made by the Dublin-based Perrigo Company, and its spokesperson Frederique Welgryn remarked, “Today’s approval is a groundbreaking expansion for women’s health in the US and a significant milestone towards addressing a key unmet need for contraceptive access.”

The American Medical Association and the American College of Obstetricians and Gynaecologists both endorse hormonal contraception that may be purchased without a doctor’s prescription. More people are thinking about this now that the Supreme Court of the United States reversed the Roe v. Wade verdict, which had safeguarded the right to an abortion, a year ago.

More than 77% of reproductive-age women agree that OTC birth control should be legalised if it can be shown to be safe and effective, and almost 40% say they would use it if it were available.

Although the pill’s price has yet to be revealed, Welgryn has assured us that Perrigo would do all in its power to make it accessible to individuals of all income levels.

 

FAQs

Question 1: What is Opill, the newly approved birth control pill?

Answer: Opill is the first oral contraceptive tablet to receive FDA clearance for over-the-counter sale in the United States. It will be available without a prescription, expanding access to birth control.

Question 2: Why is the FDA approval of Opill significant?

Answer: The approval of Opill is groundbreaking for women’s health in the US, as it addresses a key unmet need for contraceptive access. It allows women to obtain hormonal birth control without needing a doctor’s prescription.

Question 3: When will Opill be available for purchase?

Answer: Opill is expected to hit store shelves and online marketplaces in the United States in the first few months of 2019.

Question 4: How effective is Opill in preventing pregnancy compared to other OTC contraceptives?

Answer: Opill is considered more effective than other OTC contraceptives like condoms and spermicides when used as directed, with a higher efficacy in preventing unintended pregnancies.

Question 5: What are the benefits of making birth control available over-the-counter?

Answer: Making birth control available OTC benefits women who lack easy access to healthcare, live in remote areas, or face barriers in getting prescriptions. It helps reduce unplanned pregnancies and promotes women’s reproductive health.

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