WASHINGTON: The US Food and Drug Administration (FDA) has granted approval for the first over-the-counter contraceptive pill, enabling millions of women in the country to purchase birth control without a prescription. The move comes as several states tighten abortion regulations following the Supreme Court’s decision last year to overturn the nationwide legalization of the procedure through the Roe v. Wade ruling.
The daily contraceptive pill, known as Opill and manufactured by Perrigo, was initially approved for prescription use in 1973. The recent over-the-counter approval eliminates the requirement for individuals to first consult with a healthcare provider before obtaining the pill. Perrigo is expected to disclose its pricing plan for the pill next week, with availability in stores and online anticipated in the first quarter of next year.
Hurdles for Women in Obtaining Birth Control Pill in US
In a statement, Health and Human Services Secretary Xavier Becerra emphasized the significance of this approval in facilitating access to essential healthcare for Americans. The decision aims to address barriers faced by women in obtaining contraceptives, such as the cost, time, transportation, and childcare associated with healthcare provider visits.
Opill, also referred to as a “minipill,” contains progestin, a form of the progesterone hormone. Unlike combination contraceptive drugs, it does not contain estrogen. Women taking the progestin-only pill should adhere to a strict regimen, taking it within the same three-hour window every day to prevent pregnancy. Combination pills, which include both estrogen and progestin, do not have the same timing restrictions.
Dr. Jeffrey Singer, a senior fellow at the libertarian think tank Cato Institute, remarked that the approval represents a small step in the right direction, albeit with certain limitations. Deviating from the strict timing regimen requires restarting the pill from the next menstrual cycle. Common side effects of the pill include irregular bleeding, headaches, and dizziness. The FDA advises against its use for individuals with or with a history of breast cancer.
Groups like the National Catholic Bioethics Center have opposed making Opill available without prescription, asserting that physicians should be involved in health decisions, particularly for teenagers, in conjunction with parental supervision, to prevent harm. However, a panel of the FDA’s advisers unanimously voted in favor of the over-the-counter sale of Opill in May, prioritizing the prevention of unplanned or unwanted pregnancies over the drug’s potential side effects.
Perrigo acquired the daily-use pill through its acquisition of Paris-based HRA Pharma for $2.13 billion in 2021. The company’s shares rose by 2% in noon trading following the FDA’s announcement.
