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Over-the-counter birth control? Drugmaker seeks FDA approval
LA Times via Yahoo NewsFor the first time, a pharmaceutical company has asked for permission to sell a birth control pill over the counter in the U.S.
HRA Pharma’s application Monday sets up a high-stakes decision for health regulators amid legal and political battles over women’s reproductive health. The company says the timing was unrelated to the Supreme Court’s recent decision to overturn Roe vs. Wade.
Hormone-based pills have long been the most common form of birth control in the U.S., used by millions of women since the 1960s. They have always required a prescription, generally so that health professionals can screen for conditions that raise the risk of rare, but dangerous, blood clots.
The French drugmaker’s application compiles years of research intended to convince the Food and Drug Administration that women can safely screen themselves for those risks and use the pill effectively.
“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.
HRA Pharma’s application Monday sets up a high-stakes decision for health regulators amid legal and political battles over women’s reproductive health. The company says the timing was unrelated to the Supreme Court’s recent decision to overturn Roe vs. Wade.
Hormone-based pills have long been the most common form of birth control in the U.S., used by millions of women since the 1960s. They have always required a prescription, generally so that health professionals can screen for conditions that raise the risk of rare, but dangerous, blood clots.
The French drugmaker’s application compiles years of research intended to convince the Food and Drug Administration that women can safely screen themselves for those risks and use the pill effectively.
“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.
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