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Advocates Seek OTC Contraceptives

Firms Push to Make Birth-Control Pills Available Without Prescriptions

THE NEW YORK TIMES – A few years ago, after learning she had high blood pressure, Shannon Connell-Robichaud asked her doctor to switch her birth-control pill prescription.

She had read that the pill she had been prescribed put people around her age with that condition at high risk of a stroke.

The doctor agreed, she said — but only after Ms. Connell-Robichaud, a 32-year-old paralegal, shared a list of the blood-pressure measurements she had been keeping on her own. After that, she recalled, the doctor said, “Hey, maybe you’re right.”

The question of whether women can monitor their own health risks in taking birth-control pills is at the heart of a debate now playing out in the pharmaceutical industry and at the Food and Drug Administration:

Should oral contraceptives be made available over the counter rather than requiring a prescription?

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Though they are taken by millions of people, birth-control pills can interact with certain medical conditions in ways that have always placed them in the prescription category, meaning a doctor’s oversight is required.

If the F.D.A. approves an over-the-counter version, it will be effectively saying that women with underlying health risks who choose that option will have to do their own research on how the birth-control pill would interact with their condition and any other medications they are taking.

Reproductive-rights activists in the United States view an over-the-counter birth-control pill as an easy and effective tool for rural, poor and historically marginalized communities to avoid unwanted pregnancies — reducing their barriers to health care and lowering the abortion rate along the way.

At least two drug companies want to apply to the F.D.A. to make the switch to an over-the-counter version, and have been in communication with the agency about their plans. But after years of preliminary trials to clear the agency’s research and consumer-testing hurdles, neither has reached the stage of applying yet.

The F.D.A. defenders say that by asking many questions and demanding rigorous testing, the agency is being prudent …

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