Saturday, June 10, 2023

Over-the-counter birth control? The drugmaker seeks FDA approval.

WASHINGTON — For the first time, a pharmaceutical company has applied for permission to sell a birth control pill without a prescription in the US.

Monday’s HRA Pharma application sets 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 recent Supreme Court decision that overturned Roe v. Wade.

Hormone-based pills have long been the most common form of birth control in the US, used by millions of women since the 1960s. They have always required a prescription, usually for birth control professionals. health can detect conditions that increase the risk of rare but dangerous blood clots.

The French drugmaker’s application collates years of research with the intention of convincing 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 widely available,” said Frederique Welgryn, chief strategy officer at HRA.

FDA approval could come as early as next year and would only apply to HRA’s pill, which would be sold under its original brand name, Opill. The company acquired the decades-old drug from Pfizer in 2014, but it is not currently marketed in the US.

Reproductive rights advocates want to see other prescription contraceptives move over the counter and, eventually, abortion pills to do the same.

That potential for a precedent-setting decision again places the FDA under an intense political spotlight.

Late last year, the agency was condemned by abortion opponents and praised by women’s rights advocates when it relaxed access to abortion pills. The agency faced similar political pressure in 2006 when it approved over-the-counter use of the Plan B emergency contraceptive pill.

Many conservative groups emphasize that they are only interested in restricting abortion, and state bans often explicitly exclude contraception.

World Nation News Desk
World Nation News Desk
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