WASHINGTON (AP) — Federal health advisers said Wednesday that a decade-old birth control pill should be sold without a prescription, paving the way for likely US approval of the first over-the-counter contraceptive drugs.
A panel of FDA advisers voted unanimously in favor of drug maker Perrigo’s request to sell the once-a-day drug over the counter. The recommendation came at the end of a two-day meeting focused on whether women can safely and effectively take the pill without professional supervision. A final FDA decision is expected this summer.
If the agency follows through on the nonbinding recommendation, Perrigo’s drug, Opill, would be the first contraceptive pill to move from behind the pharmacy counter to store shelves. The company said sales could begin later this year if OK.
Outside experts say they are almost all confident that women of all ages can use the drug appropriately without first seeing a health care provider.
“On the balance between benefit and risk, we would have a hard time justifying not taking this action,” said Maria Coyle, a pharmacist at Ohio State University, who chaired the panel. “The drug is incredibly effective, and I think it will be as effective in the over-the-counter realm as it is in the prescription realm.”
The positive vote came despite several criticisms from FDA scientists about how Perrigo studied the drug, including questions about whether study participants understood and followed instructions. in labeling.
“We have an application with many complex issues and uncertainties, including questionable reliability,” said Dr. Pamela Horn of the FDA to panelists on Tuesday.
But the panel largely brushed those concerns aside, emphasizing the benefits of providing more effective birth control, especially to young people and low-income groups, than what’s available over the counter today, such as condoms and diaphragms.
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 they are not taken at the same time every day.
The FDA’s decision will not apply to other birth control pills, only Opill, although advocates hope that an approval decision could prompt other drugmakers to seek over-the-counter ones. sales. Birth control pills are available without a prescription in most of South America, Asia and Africa.
Over-the-counter drugs are often less expensive, but generally not covered by insurance. Requiring insurers to cover over-the-counter birth control would require a change in federal government regulation.
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. But some women should not take it, especially those with breast cancer, because of the risk that it can accelerate tumor growth. Women with unusual vaginal bleeding are advised to speak with a doctor before using it, as bleeding may indicate a serious health issue.
But in reading comprehension studies conducted by Perrigo, 68% of women with unexplained bleeding incorrectly answered that they could take the drug. And some women with breast cancer also told researchers they could use Opill.
The panel members said that almost all women with a history of breast cancer are under the care of a cancer specialist, who will advise them not to take hormonal drugs that could worsen their condition.
“I think any woman who has had a breast cancer diagnosis in the past is very aware of this, so I don’t think that would be a concern,” says Dr. Deborah Armstrong of Johns Hopkins University.
Perrigo said its 880-patient study of the drug showed that women would continue to take the pill every day if it were available over-the-counter. But the FDA found some problems with the study, including that more than 30% of participants falsely reported taking more pills than they were actually given. FDA reviewers said the problem called into question the company’s overall conclusions about the drug’s use and effectiveness.
FDA regulators have also suggested changes in US 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.
“Opill over the counter will give us another option for 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 who supported Perrigo’s application during a public comment session Tuesday.
Catholic groups, including the United States Conference of Catholic Bishops, oppose the move, saying women should be examined by a doctor before getting it.
Even if the pill is approved, it’s unclear how popular it will be. Opill has not been marketed in the US since 2005 and was previously owned by Pfizer. Perrigo acquired the drug in its purchase of French drugmaker HRA Pharma last year.
