French Firm Seeks U.S. FDA Approval For OTC Birth Control Pill
For the first time, a pharmaceutical company has requested approval to sell a birth control pill over the counter in the United States, Matthew Perrone reported for the Associated Press (AP).
Photo Insert: An FDA approval could be granted next year, but only for HRA's tablet, which would be offered under its original brand name, Opill.
The application filed by HRA Pharma on Monday sets up a high-stakes decision for health regulators in the midst of legal and political fights over women's reproductive health. According to the company, the timing was unrelated to the recent Supreme Court ruling overturning Roe v. Wade.
Hormone-based tablets have long been the most popular form of birth control in the United States, with millions of women using them since the 1960s. They have always required a prescription, primarily to let doctors test for diseases that increase the risk of uncommon but dangerous blood clots.
Years of research have been compiled in the French drugmaker's application in order to persuade the Food and Drug Administration (FDA) that women can safely screen themselves for such dangers and utilize the tablet properly.
“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,” said Frederique Welgryn, HRA’s chief strategy officer.
An FDA approval could be granted next year, but only for HRA's tablet, which would be offered under its original brand name, Opill.
The company acquired the decades-old medicine from Pfizer in 2014, but it is not currently available in the United States. Reproductive rights campaigners want other prescription contraceptives to become available over the counter, and eventually, abortion drugs.
Because of the possibility of a precedent-setting ruling, the FDA is once again under severe political scrutiny.
When it loosened access to abortion medicines late last year, the FDA was chastised by abortion opponents and praised by women's rights activists. When it approved the over-the-counter use of the emergency contraceptive drug Plan B in 2006, the agency encountered similar political pressures.