Subscribe now and stay updated on the latest news regarding reproductive rights. You’ll receive a daily email digest, called myFT Daily Digest, every morning.
We are pleased to announce the approval of the first-ever non-prescription birth control pill by the US drug regulator. This marks a significant advancement in the ongoing battle for reproductive rights across the nation.
The Food and Drug Administration (FDA) has granted approval to Opill, an oral contraceptive manufactured by Irish-American pharmaceutical group Perrigo, for non-prescription use. This groundbreaking decision allows the pill to be conveniently purchased from pharmacies, convenience stores, grocery stores, and online platforms.
The approval of Opill is expected to enhance accessibility to contraceptives and has been wholeheartedly welcomed by advocates of reproductive rights, especially in light of increased restrictions on abortion in many states.
Patrizia Cavazzoni, the director of the FDA’s drug evaluation and research center, expressed that this approval grants millions of people in the US the option to consider the pill.
This development marks a significant milestone in the fight for reproductive rights in the US, particularly after the Supreme Court ruling that overturned Roe v. Wade, thereby revoking women’s constitutional right to abortion, which had been in effect since 1973.
The legality of the abortion pill mifepristone remains uncertain following the Supreme Court’s suspension of a Texas federal judge’s ruling that sought to withdraw FDA approval. If upheld, this ruling would further limit access to the drug, even in states with existing abortion protections.
Efforts by Democratic legislators to have the FDA approve the over-the-counter availability of this contraceptive have faced strong opposition from conservative religious groups.
Regarding Opill, Cavazzoni emphasized, “When used as directed, daily oral contraception is safe and more effective than currently available non-prescription contraceptive methods in preventing unintended pregnancy.”
The FDA has specified that Opill should not be used by individuals with a current or previous diagnosis of breast cancer, nor in conjunction with other hormonal birth control products. The pill, which contains progestin, a hormone regulating the menstrual cycle and preventing pregnancy, has a long history of safe and effective use as a contraceptive.
Perrigo, based in Ireland, has announced that Opill will be available in-store and online across the US starting in the first quarter of 2024.
Frederique Welgryn, Perrigo’s global vice-president for women’s health, views this approval as a groundbreaking expansion for women’s health in the US, addressing a significant unmet need for contraceptive access.
The pricing details for Opill will be determined in the forthcoming months. Welgryn emphasized that the pill will be affordable for most women, and subsidized prices will be available for those requiring financial assistance. As an over-the-counter medication, Opill will not be covered by health insurers, although President Joe Biden has expressed his commitment to making contraception more affordable.
According to Perrigo, 45% of the 6 million pregnancies in the US each year are unintended. Furthermore, one-third of adult US women who have sought prescriptions or refills for birth control products, including the pill, have encountered difficulties in obtaining them.
Perrigo estimates that there are approximately 40 million sexually active women in the US who do not wish to become pregnant, and among them, 15 million are using less effective methods than Opill. Another 10 million women are already using the pill and may find an over-the-counter alternative more convenient. For all these women, Opill is set to be a game-changer.
Perrigo stated, “There is a massive public health need…existing over-the-counter contraceptive options are limited to the least effective methods. Opill aims to reduce unintended pregnancies and contribute to the context of preserving reproductive rights.”
Opill, initially developed by Pfizer, acquired its FDA approval as a prescription medication in 1973. While Perrigo took ownership of the brand in 2014, Pfizer remains involved in its production, which currently takes place in Ireland, Germany, and the US.
Denial of responsibility! VigourTimes is an automatic aggregator of Global media. In each content, the hyperlink to the primary source is specified. All trademarks belong to their rightful owners, and all materials to their authors. For any complaint, please reach us at – [email protected]. We will take necessary action within 24 hours.
