“I think this is a huge game changer!” Dr. Maria Sophocles cheered a unanimous vote by a Food and Drug Administration advisory panel to make Opill the first birth control pill available in the United States without a prescription. If the FDA agrees, it’d let shoppers pick the medication off a store shelf, without having to consult health care providers. Dr. Sophocles says it would strike down so many barriers. “I’ve seen firsthand how hard it is for some women to get to my office. And there’s the co-pay and the waiting. And this will eliminate all of that.”
“I think this represents a landmark in our history of women’s health. Unwanted pregnancies can really derail a woman’s life,” said Dr. Margery Gass, a panel member. Advisors to the FDA emphasized they believed Opill is safe and effective — but several expressed reservations about user studies conducted by its maker, HRA Pharma, which showed 15% of women may miss three or more doses at least once a month. Opill — a progestin-only drug — should be taken daily within the same three-hour window. But it works well, advisors said.
“The health risks of pregnancy — which is a condition these products would prevent — is much greater than the use of any contraceptive product. And this is among the safest of the contraceptive products,” said panelist Dr. Elise Berlan. New Jersey’s Dr. Kirstyn Brandi added, “There was so much testimony from doctors, pharmacists, young people that all said, this is such a big need — that we need this out there.” The FDA isn’t expected to vote on Opill until perhaps the end of this summer.
