Medical Group: Sell the Pill Without Prescription
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Cost of Oral Contraceptives
Another concern about switching drugs from prescription to over the counter is extra costs for the patient. Insurance covers prescription drugs but not over-the-counter drugs.
"It is possible that some women might be adversely affected by changing to over-the-counter OCs [oral contraceptives] if they lose insurance coverage for their preferred contraceptive method," the ACOG committee writes.
The health reform law requires health plans to cover preventive services such as FDA-approved contraceptives and eliminates co-pays for them. But it's not yet clear whether that would apply to over-the-counter birth control pills, Grossman says.
The FDA could on its own decide to make oral contraceptives available without a prescription. But such switches usually are instigated by drug companies, Grossman says. He says he knows of no drugmakers seeking to sell the pill over the counter.
And according to FDA spokeswoman Stephanie Yao, for a switch to occur the FDA needs to determine whether keeping a drug available only by prescription is necessary to protect the public’s health. The FDA might require the drugmaker to do additional research, such as a study to determine whether patients can understand labeling directions on their own, Yao says.
Several drugmakers weighed in on the debate.
"Bayer believes that the decision to use hormonal contraceptives should be made between a woman and her health care provider," says Rosemarie Yancosek, spokeswoman for Bayer HealthCare Pharmaceuticals, which markets such birth control pills as Yaz and Natazia.
William Foster, a spokesman for Janssen Pharmaceuticals, which markets the Ortho birth control pills, would not say whether his company plans to seek to make the contraceptives available over-the-counter.
"This is a very complex public health issue that has been debated for years by family planning organizations, women's health groups, and physicians," Foster says. "Janssen believes the [FDA] should consider the perspective of each of these organizations" in determining whether over-the-counter birth control pills are in the best interest of public health.