HRA Pharma’s application sets up a high-stakes decision for health regulators amid legal and political battles over women’s reproductive health.
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.
That potential for a precedent-setting decision once again places the FDA under an intense political spotlight. 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 thatBirth control pills are available without a prescription across much of South America, Asia and Africa. Last year, Paris-based HRA won British approval for the first birth control pill available there without a prescription.
For most women, the drugs are overwhelmingly safe. For every 10,000 women taking combination pills annually, three to nine will suffer a blood clot, according to FDA data. That compares with one to five clots among 10,000 women who aren’t taking birth control.
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