A panel of health advisers convened by the FDA voted unanimously in favor of making a decades-old birth control pill available without a prescription, opening the door for the first-ever approval of over-the-counter oral contraceptives in the U.S.
The panel approved drugmaker Perrigo's request to sell its once-a-day chemical contraceptive Opill over the counter Wednesday.
Currently, a prescription is required. in the U.S. for oral contraceptives. If the FDA follows through on the recommendation, which is non-binding, Opill would become the first-ever contraceptive pill to be moved from behind the pharmacy counter onto store shelves.
A final decision is expected to be made at the end of this summer, the Washington Post reports, and Perrigo said it could begin selling the drug late this year if approved.
The FDA’s decision will not apply to other chemical contraception pills, but proponents hope that an approval might drive other drugmakers to seek over-the-counter sales.
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The panel’s recommendation came after a two-day meeting centered on the company's research into whether women could safely and effectively use Opill without medical supervision.
The panel members “said they were mostly confident that women of all ages could use the drug appropriately without seeing a health provider first,” the Washington Post report said.
“In the balance between benefit and risk, we’d have a hard time justifying not taking this action,” said Maria Coyle, an Ohio State University pharmacist, who chaired the panel. “The drug is incredibly effective, and I think it will be effective in the over-the-counter realm just as it is in the prescription realm.”
“I do believe this is a viable option to support access and will support the prevention of unintended and unwanted pregnancies,” said Jolie Haun, a researcher with the Department of Veterans Affairs.
The panel’s vote came in spite of numerous issued raised by FDA scientists about how Perrigo had studied its drug. The concerns include questions about whether study participants were able to understand and follow labeling instructions.
“We have an application with many complicated issues and uncertainties, including questionable reliability,” the FDA’s Dr. Pamela Horn told the panelists during the two-day meeting on Tuesday.
But, according to the WaPo report, “the panel largely set those concerns aside, emphasizing the benefits of providing more effective birth control — particularly to young people and lower-income groups — than what’s available over the counter now, like condoms and gels.”
Most chemical contraception pills used in the U.S. today have a combination of progestin and estrogen. However, Opill is part of an older class of contraceptive that contains progestin only. The older drugs typically have fewer side effects and health risks, the report said, but can be less effective if not taken around the same time each day.
Opill first gained approval in the U.S. in 1973 based on data saying it was more than 90% effective in preventing pregnancy when taken daily. It remains to be seen how popular it would be if it gets over-the-counter approval; it has not been marketed in the U.S. since 2005.
In addition to concerns over the comprehension issues with Perrigo’s study participants the FDA found that more than 30% of participants erroneously reported taking more pills than they were actually given, raising questions over the drug company’s overall conclusions about its drug’s use and effectiveness.
Additionally, FDA regulators indicated that changes in U.S. demographics since Opill was first tested — including increased obesity and other chronic conditions— could decrease the drug’s effectiveness.
Regardless of the FDA’s concerns, Opill enjoys the support of dozens of pro-abortion groups and allied medical groups that have been pushing for expanded birth control access. Catholic groups, such as the United States Conference of Catholic Bishops (USCCB), oppose the move to approve the contraceptive for over-the-counter use, arguing that women should be evaluated by a physician before obtaining it.
Chemical contraceptive pills are available without a prescription throughout much of South America, Asia, and Africa, according to the Washington Post report.
The panel’s approval of the Opill birth control pill for over-the-counter use comes as the FDA is being sued from groups on both sides of the chemical abortion pill debate – with in-person dispensing and medical exams also at the heart of the issue.
