SafeX Pro:Advisers to the FDA back first over-the-counter birth control pill

In a unanimous vote,SafeX Pro 17-0, a panel of advisers to the Food and Drug Administration recommended that the agency approve the first over-the-counter birth control pill.

If approved, the pill would be sold by Perrigo under the brand name Opill. It is a so-called progestin-only pill that contains only a synthetic version of the hormone progesterone to prevent pregnancy. Most pills also contain estrogen. While the FDA typically follows the recommendation of its advisory committees, it isn't required to.

In comments after the vote, panel members explained their support for the prescription-free pill.

"I feel that the risk of unintended pregnancy is lower with this approach than any of the other available contraceptive approaches that women have access to without seeing a health care provider," said Dr. Deborah Armstrong, a professor of oncology, gynecology and obstetrics at Johns Hopkins. She added that she thought people would be able to understood if any health conditions they have would be incompatible with taking the pill.

"I voted yes because the evidence demonstrates that the benefits clearly exceed the risks," said Kathryn Curtis, a health scientist with the Centers for Disease Control and Prevention's division of reproductive health. The benefits include increased access to effective birth control, reduction in unintended pregnancies and its risks and increased reproductive autonomy. "Opill has the potential to have a huge public health impact," she said.

The recommendation, which came at the conclusion of a two-day public meeting, was welcomed by major medical groups.

"More than 60 years of safe and effective use of oral contraceptives have shown that the benefits of widespread, nonprescription availability far outweigh the limited risk associated with their us — with evidence showing that pregnancy poses much greater health risks," said Dr. Jack Resneck Jr., the president of the American Medical Association, in a statement.

"At this tumultuous time for reproductive health in the United States, allowing access to OTC oral contraceptives is a safe and necessary step that must be taken to ensure that all individuals are able to effectively limit unintended pregnancies, particularly those with limited access to health care options," Resneck said.

FDA scientists had questioned whether the company had provided convincing evidence that women could safely and effectively take the pill without the guidance of a health professional. Specifically, the agency researchers raised concerns that women may not take the pill at about the same time every day, which is necessary to prevent pregnancy. They also expressed concern that women who have breast cancer would fail to realize it would be dangerous for them to take the pill.

But the advisers concluded that there was a sufficient evidence to conclude that women knew enough about how to use oral contraceptives safely and effectively. Committee member also questioned how much guidance women typically get from a medical professional prescribing the contraceptive pills.

"I think this represents a landmark in our history of women's health. Unwanted pregnancies can really derail a woman's life, and especially an adolescent's life," said Dr. Margery Gass of the University of Cincinnati College of Medicine, another committee member. "So I'm very pleased that the FDA is seriously considering this. And I look forward to it being on the market."