FDA Approves First Over-the-Counter Contraceptive Pill in the US
July 13 (Reuters) – The U.S. Food and Drug Administration (FDA) has granted approval for the first over-the-counter contraceptive pill in the country, allowing millions of women to purchase birth control without a prescription.
The approval of the contraceptive pill comes at a time when more states are implementing strict abortion laws following the Supreme Court’s decision last year to overturn the Roe v. Wade ruling, which legalized the procedure nationwide.
The pill, called Opill and manufactured by Perrigo (PRGO.N), was initially approved for prescription use in 1973. The recent over-the-counter approval means that individuals can now obtain it without first consulting a healthcare provider.
Perrigo is expected to release its pricing plan for the pill next week, with availability in stores and online scheduled for the first quarter of next year.
Health and Human Services Secretary Xavier Becerra hailed the approval as an important step in providing meaningful access to essential healthcare for Americans.
The approval of the over-the-counter contraceptive pill will help women overcome barriers such as the cost and time associated with seeing a healthcare provider, transportation issues, and finding childcare during the appointment.
Opill, also known as a “minipill,” contains progestin, a form of the progesterone hormone that plays a key role in the menstrual cycle and pregnancy. Unlike combination contraceptive drugs, Opill does not contain the hormone estrogen.
Women are advised to take the progestin-only pill at the same time every day to ensure its effectiveness. Combination pills, which contain both estrogen and progestin, do not have this requirement.
Dr. Jeffrey Singer, a senior fellow at the libertarian think tank Cato Institute, noted that while the approval is a step in the right direction, the pill does have its limitations. If women fail to take it at precisely the same time every day, they will have to start the pill cycle again with their next menstrual cycle.
The most common side effects of the pill include irregular bleeding, headaches, and dizziness. The FDA advises against taking it for those who have or have had breast cancer.
Opposition to the availability of Opill without a prescription has come from organizations such as the National Catholic Bioethics Center, arguing that physicians and parental supervision should be involved in health decisions, particularly for teenagers, to prevent harm.
In May, the FDA’s advisers unanimously voted in favor of selling Opill over-the-counter. They emphasized that the potential harm caused by unplanned or unwanted pregnancies far outweighed the potential side effects of the drug.
Perrigo acquired the daily-use pill through its acquisition of Paris-based HRA Pharma in 2021, a deal that amounted to $2.13 billion.
Following the FDA approval, shares of Perrigo rose by 2% during noon trading.
(This story was refiled to remove picture)
Reporting by Manas Mishra and Sriparna Roy in Bengaluru; Editing by Arun Koyyur