WASHINGTON (AP) — Federal health advisers said Wednesday that a decades-old birth control pill should be sold over the counter, paving the way for 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-daily medication on store shelves alongside eye drops and allergy pills. The recommendation came at the end of a two-day meeting that focused on whether women could safely and effectively take the pill without professional guidance. A final decision from the FDA is expected this summer.
If the agency follows the non-binding recommendation, Perrigo’s drug, Opill, would become the first birth control pill to emerge from behind the pharmacy counter. The company said sales could begin at the end of this year if things go well.
The outside experts said they were most confident that women of all ages could use the drug properly without first seeing a healthcare provider.
“If we balance the benefits and risks, it would be hard for us to justify 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 just as effective in the over-the-counter world as it is by prescription.”
The positive vote came despite numerous criticisms from FDA scientists about how Perrigo studied the drug, including 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,” FDA’s Dr. Pamela Horn told panelists Tuesday.
But the panel largely ignored those concerns, emphasizing the benefits of providing more effective birth control — particularly for youth and lower-income groups — than what’s now available over the counter, such as condoms and gels.
Most birth control pills used in the US today contain a combination of progestin and estrogen. Opill is part of an older class of progestin-only contraceptives. They generally have fewer side effects and health risks, but may be less effective if not taken around the same time each day.
The FDA’s decision doesn’t apply to other birth control pills, though proponents hope an approval decision could prompt other drugmakers to seek self-care. Birth control pills are available without a prescription in much of South America, Asia, and Africa.
Opill was first approved in the US five decades ago based on data showing it was more than 90% effective in preventing pregnancy when taken daily. Even if the pill is approved over the counter, it’s unclear how popular it is. Opill has been off the market in the US since 2005.
Some women should not take it, especially women with breast cancer, because of the risk that it could accelerate tumor growth. Women who have unusual vaginal bleeding are instructed to talk to a doctor before using it, as bleeding may indicate a serious health problem.
But in reading comprehension studies conducted by Perrigo, 68% of women with unexplained bleeding incorrectly answered that they could take the drug. And a few women with breast cancer also told researchers they could take Opill.
Panelists said nearly all women with a history of breast cancer would be under the care of a cancer specialist, who would advise them not to take hormonal drugs that could make their condition worse.
“I think any woman who’s been diagnosed with breast cancer in the past is very aware of that, so I don’t think that’s going to be a problem,” said Dr. Deborah Armstrong of Johns Hopkins University.
Perrigo said his 880-patient study of the drug showed that women will consistently take the pill daily if it’s available over the counter. But the FDA found several problems in the study, including more than 30% of participants falsely reporting taking more pills than they actually received. FDA reviewers said the issue called into question the company’s overall conclusions about the drug’s use and effectiveness.
FDA regulators also suggested that changes in U.S. demographics since the pill was first tested — including increased obesity and other chronic conditions — could reduce the drug’s effectiveness.
Despite those concerns, Opill has the support of dozens of reproductive rights and medical groups that have long pushed for expanded access to birth control.
“Over the counter Opill would give us one more option of access and the more options available the better,” said Clare Coleman, president of the National Family Planning and Reproductive Health Association
Coleman was one of more than 25 speakers to support Perrigo’s application at a public comment session Tuesday.
Catholic groups, including the United States Conference of Catholic Bishops, are opposed to the move, saying women should be evaluated by a doctor before getting it.
Perrigo has not publicly discussed pricing for the drug, if approved. Over-the-counter drugs are usually less expensive, but are generally not covered by insurance. Requiring insurers to cover over-the-counter birth control would require a regulatory change by the federal government.
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