Federal health advisers said Wednesday that a decades-old birth control pill should be sold without a prescription, paving the way for a likely U.S. approval of the first over-the-counter contraceptive medication.
The panel of FDA advisers voted unanimously in favor of
drugmaker Perrigo’s request to sell its once-a-day medication over the counter.
The recommendation came at the close of a two-day meeting focused on company
research into whether women could safely and effectively take the pill without
professional supervision. A final FDA decision is expected this summer.
If the FDA follows the nonbinding recommendation, Perrigo’s
drug, Opill, would become the first contraceptive pill to be moved out from
behind the pharmacy counter onto store shelves. Currently, a prescription is
required in the U.S.
The outside experts said they were confident that women of
all ages could use the drug appropriately without seeing a health provider
first.
“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, who voted in favor
of the pill.
The positive vote came despite numerous criticisms from FDA
scientists about how Perrigo studied the drug, including whether study
participants were able to understand and follow labeling instructions.
But 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 diaphragms.
Most birth control pills used in the U.S. today contain a
combination of progestin and estrogen. Opill is part of an older class of
contraceptives that only contain progestin. They generally have fewer side
effects and health risks but can be less effective if they’re not taken around
the same time daily.
Nonprescription medicines are usually cheaper, but generally
not covered by insurance. Requiring insurers to cover over-the-counter birth
control would require a regulatory change by the federal government.
Birth control pills are available without a prescription
across much of South America, Asia and Africa. -AP