HRA Pharma is making the case that women can safely screen themselves for rare blood clots and that they don't need a prescription.
Many conservative groups stress they are only interested in curtailing abortion, and state bans often explicitly exclude contraception.
In each case, companies must show that consumers can understand the drug’s labeling, evaluate its risks and use it safely and effectively without professional supervision. HRA spent seven years conducting the FDA-required studies, including a trial that followed 1,000 women taking its pill for six months.
Birth control pills are available without a prescription across much of South America, Asia and Africa. Last year, Paris-based HRA won U.K. approval for the first birth control pill available there without a prescription. 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.But estrogen also accounts for most of the blood clot risk associated with oral contraceptives. FDA’s labeling warns against their use in certain women already at risk for heart problems, such as those who smoke and are over 35.
“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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