The Food and Drug Administration on July 13 approved an over-the-counter birth control pill – the first daily oral contraceptive approved for use in the U.S. without a prescription.
Opill (norgestrel), manufactured by Dublin-based Perrigo Co., was first approved for prescription use in 1973. Over-the-counter sales of Opill in the U.S. are expected to begin in early 2024, according to Perrigo, which said the pill has been found to be 93% effective in preventing pregnancy with typical use, similar to prescription oral contraceptives.
White Plains Hospital Director, Obstetrics & Gynecology, Dr. Jay Lupin, acknowledged that the search for an over-the-counter birth control pill in the U.S. has been ongoing for some time, but cautioned that the FDA’s approval might not be the perfect solution for everyone who has been waiting for such a development.
Opill “is a progesterone-only pill (no estrogen in it) and though it is effective, especially compared to other over-the-counter contraceptive methods, it is less effective than the traditional combined pill,” he said.
Dr. Lupin also brought up the matter of cost to the consumer, noting that Perrigo has not specified what that cost will be “Usually, once a prescription drug becomes an over-the-counter product, it’s no longer covered by one’s prescription insurance plan,” he said. “And while [Opill’s] potential side effects are generally considered to be similar to prescription birth control pills, there may still be some question of who you should consult to determine if use is appropriate and what to do if side effects occur.”
He recommends those considering taking Opill to consult first with their PCP or OB/GYN; if a woman decides to take the pill and experiences side effects, she should arrange for a return visit. The FDA said the pill’s most common side effects include “irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating.”
Dr. Lupin also noted that the timing of the announcement could be construed as sending a political message, something that other observers have said in the wake of the Supreme Court’s reversal of Roe vs. Wade and the fact that, in June, President Joe Biden issued an executive order asking the Treasury, Labor, and Health and Human Services secretaries “to consider new actions to improve access to affordable over-the-counter contraception.”
Senate Democrats have reintroduced legislation to require such coverage.
More than 100 countries currently provide oral contraceptive pills over the counter without a prescription, according to the American Academy of Family Physicians. A Washington Post article attributed the lag to such factors as “a lack of interest by the pharmaceutical industry, caution by the FDA, the stigma surrounding women’s reproductive health issues and the battle involving Plan B” (levonorgestrel), an emergency contraceptive that has faced various legal battles over the years.
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