A pharmaceutical company is seeking authorization from the Food and Drug Administration (FDA) to sell its birth control drug over-the-counter without a prescription.
HRA Pharma’s birth control pill, Opill, employs progestogen, a synthetic form of the naturally-occurring hormone progesterone. The drug has a reduced risk of serious side effects like severe blood clots, which are associated with birth control pills that use estrogen as an active ingredient.
Birth control typically requires prescriptions in the United States, so healthcare providers can screen women for conditions that raise the risk of blood clots. HRA Pharma’s application to the FDA seeks to convince the regulatory body that women can safely screen themselves for such conditions, according to the Associated Press.
“For a product that has been available for the last 50 years, that has been used safely by millions of women, we thought it was time to make it more available,” stated Frederique Welgryn, HRA’s chief strategy officer.
HRA’s parent company, Perrigo, issued a statement that claimed that dropping the prescription requirement “would improve access to a contraceptive method that is well tolerated and notably more effective at preventing pregnancy than all current methods available [over-the-counter].”
HRA is not the only pharmaceutical company seeking over-the-counter approval from the FDA.
Cadence Health, another manufacturer of birth control pills, is working on its own application, according to The New York Times. The company stated that it has been in close dialogue with the FDA and will likely apply for its birth control pill to be designated an over-the-counter drug in the next year or two.
The Centers for Disease Control and Prevention (CDC) encourages the broad use of contraceptives on its website, pointing out that “most unintended pregnancies result from not using contraception or from not using it consistently or correctly.”
