Pharmaceutical company seeks U.S. FDA approval for over-the-counter birth control pill

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HRA Pharma’s application on Monday sets up a high-stakes decision for U.S. health regulators amid legal and political battles over women’s reproductive health

For the first time, a pharmaceutical company has asked for permission to sell a birth control pill over the counter in the U.S.

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

Many common medications have made the switch from behind the pharmacy counter, including drugs for pain relief, heartburn and allergies. “A lot of our research has been about making the case to help inspire and support a company to take this work on,” said Kelly Blanchard, president of Ibis Reproductive Health, a group member that supports abortion and contraceptive access.

Most birth control pills contain progestin plus estrogen, which can help make periods lighter and more regular. Progestin-only pills are generally recommended for women who can’t take the more popular combination pills due to health issues. “What I definitely see is a misunderstanding of the dangers of these pills. It is much safer to take the pill than to be pregnant” said Dr. Maura Quinlan, a Northwestern University physician and member of the American College of Obstetricians and Gynecologists. She was not involved in HRA’s application or research.

 

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