A group of consultants from Food and Drug Administration (FDA) advised the agency to approve first over-the-counter birth control pill by unanimous vote 17-0.
If approved, Perrigo, a U.S. private label maker of over-the-counter pharmaceuticals, would sell brand-name birth control pills. opill.
Opill is a so-called progestogen pill that only contains a synthetic version of the hormone progesterone to prevent pregnancy. Most pills also contain estrogen.
Although the FDA generally follows the advice of its advisory committees, this is not required.
In the comments after the vote, the committee members explained their support for over-the-counter pills.
“I think the risk of unwanted pregnancy with this approach is lower than with any other available birth control method that women have access to without medical advice.” said Dr. Deborah ArmstrongProfessor of Oncology, Gynecology and Obstetrics at Johns Hopkins University. Armstrong added that he thinks people can figure out if any of their health conditions are incompatible with taking the pill.
“I voted yes because the data shows that the benefits clearly outweigh the risks.” Katherine Curtis said Research Associate, Division of Reproductive Health, Centers for Disease Control and Prevention. Benefits include greater access to effective contraceptive methods, a reduction in unwanted pregnancies and their associated risks, and greater reproductive autonomy. “Opill could have a huge impact on public health,” he said.
The recommendation for America’s first over-the-counter birth control pill came at the end of a two-day public meeting. has been well received by major medical groups.
“More than 60 years of safe and effective use of oral contraceptives has shown that the benefits of their widespread availability without a prescription far outweigh the limited risks associated with them and the evidence that pregnancy poses a much greater health risk,” said Dr. Jack Reznek. . Jr., President of the American Medical Association.
The FDA consultants concluded in their recommendation that there is sufficient evidence to conclude that women are reasonably aware of how to use oral contraceptives safely and effectively.
Source: La Opinion
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