In a milestone for the movement for women’s reproductive freedom, the US Food and Drug Administration (FDA) made history by allowing a birth control pill to be sold over the counter for the first time on Thursday.
Opill, which will be called commercial, is said to be available in pharmacies, stores and supermarkets, in establishments divided by diffuse boundaries in this country, and for sale online, the FDA said. The Dublin-based company Perrigo, which operates the factory, promised to begin distribution through the said streets in early 2024.
“Today is a truly meaningful day,” said Patrick Lockwood-Taylor, Perrigo’s chairman and CEO, in a statement. The company hasn’t specified what the pill’s price will be, merely expressing its commitment to keeping “the most effective over-the-counter birth control method” on the market “accessible and affordable for women and people of all ages.”
For her part, Patrizia Cavazzonni, director of the FDA’s Center for Drug Evaluation and Research, stated that “daily oral contraceptives are safe” and “more effective than currently available over-the-counter methods of preventing unplanned pregnancies.” Cavazzoni was referring to condoms, spermicides and other alternatives, which are particularly popular among young people who have trouble getting a doctor’s prescription.
The approval was backed by a unanimous vote by a panel of 17 FDA independent scientific advisers (ranging from gynecologists to oncologists), who believed that the benefits of making Opill an over-the-counter drug far outweigh the risks. According to the FDA, nearly half of the 6.1 million pregnancies each year in the United States are unwanted.
The decision marks a triumph for advocates of women’s reproductive freedom in the United States, following the Supreme Court’s June 2022 ruling that overturned the half-century Roe vs. Wade precedent that banned abortion rights federal level, securing new methods of contraception became a priority.
The sight of the highest
That ruling, which restored legislative power on the issue to states (so far at least 25 have banned or severely curtailed that right), included a unanimous opinion from Clarence Thomas, the most conservative Supreme Court Justice in eight decades, one that left open the possibility to consider other precedents based on the Fourteenth Amendment, which protects the right to privacy, among other rights. One of these is Griswold v. Connecticut, the 1965 ruling that legalized the use of contraceptives by married couples. The other two are Obergefell v. Hodges (2015), which legalized gay marriage, and Lawrence v. Texas (2003), which ended bans on same-sex relationships.
Design proposed by the pharmaceutical company Perrigo for the drug Opill.AP
The FDA is also on another open front in the most conservative sectors’ war on reproductive freedom, which approved another drug, mifepristone, 23 years ago. The most popular is to terminate a pregnancy in combination with another pill: misoprostol. The first interrupts the pregnancy; the second, empties the uterus. The mixture is used in about half of the abortions performed in the country.
In January, a rule change by the FDA allowed these pills to be sold in retail pharmacies. Matthew Kacsmaryk, a federal judge appointed by Trump, temporarily shut down his administration in April. In practice, this decision never came into force. The same nine Supreme Court justices who convicted Roe last June corrected the opinion of a New Orleans appeals court, whose judges set restrictions on mifepristone administration while reviewing ultraconservative Kacsmaryk’s verdict. It is not yet clear what fate will eventually befall mifepristone. The Supreme Court ruling does not preclude these pills from being banned throughout the United States.
Alexis McGill Johnson, president and CEO of the Planned Parenthood Federation of America, the largest abortion organization in the United States, which controls about half of the clinics in the country, said after news of Opill’s approval, “We’re excited about that.” the FDA is listening to the science and removing an unnecessary barrier to accessing primary health care. We know that improved access to contraception is not a solution to the ongoing attacks on access to abortion and sexual and reproductive health. But it’s critically important, especially as states across the country continue to tighten their unpopular abortion bans and restrictions.”
In its Thursday statement, the FDA recalled how the pill must be taken (at the same time each day) to be effective.
The American Academy of Family Physicians estimates that about 100 countries offer oral contraceptive pills without a prescription. Spain, where the morning-after pill can be administered without medical intervention, is not one of them.