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New website promotes over-the-counter birth control pills

The movement began more than two decades ago. "I think the pill is safer than aspirin and aspirin is available over the counter," the FDA's head of drug research said in 1992. The Pill still requires a prescription.

Last month, the non-profit organization Ibis Reproductive Health launched a website entitled Free the Pill. The new website is designed to educate the public about why a nonprescription oral contraceptive is needed. (You can't buy the Pill on the site.)

In the run-up to November's mid-term elections, some Republican Senate candidates also proposed making oral contraceptives available without prescription. Democratic opponents claimed that that this was merely an election year ploy to attract female voters by distracting them from the Republican Party's anti-abortion stance and the recent Hobby Lobby Supreme Court decision.  Since over-the-counter drugs are not covered by health insurance, making birth control pills available without prescription would make the Affordable Care Act's contraceptive mandate irrelevant.

Oral contraceptives are used by 16 percent of American women, the single-biggest birth control category, the National Center for Health Statistics reported last month, although that varies widely according to age, race, and level of education (graphic is here).

The idea for making birth control pills available without prescription in the United States is not new: it originated in the early 1990s among health care practitioners and population experts working in conjunction with the U.S. Food and Drug Administration. In 1992, Philip A. Corfman, director of the FDA Center for Drug Evaluation and Research, proclaimed at birth control conference: "I think the pill is safer than aspirin and aspirin is available over the counter.'"

The following year, the FDA announced it would hold an open hearing to discuss issues related to providing oral contraceptives without prescription but canceled it in response to public criticism from feminist health activists and consumer protection groups who had participated in the Senate hearings on the safety of the Pill in the 1970s and continued to argue that use of the Pill carried too many contraindications to be made available without prescription. "Don't make the pill easier to acquire," pleaded Judy Norsigian, co-founder of the Boston Women's Health Book Collective (now Our Bodies Ourselves) Sidney Wolfe, director of Public Citizen's health research group, argued that removing the prescription requirement would increase the use of the pills by women at risk for serious side effects. Cindy Pearson, executive director of the National Women's Health Network observed, "A birth control prescription is the poor woman's ticket to health care." Women who visited a birth control clinic not only received a prescription for contraceptives, they were also screened for sexually transmitted diseases, high blood pressure, cancer, and other health problems.

For the next decade, proponents of OTC oral contraceptives focused on getting emergency contraception – a critically important but tiny slice of the market – approved by the FDA and making it available without prescription. (It was approved in 2000, with limitations, and is far harder to get in some other countries.) Then, in 2004, Ibis Reproductive Health created the Oral Contraceptives Over-the-Counter (OCOTC) Working Group "to evaluate objectively the risks and benefits of demedicalizing contraceptive care, with an eye toward improving access to OCs and potentially other hormonal contraceptive methods by making them available without a prescription."

The new Free the Pill website is the latest step in the women's health advocacy organization's efforts to set the pill free from the prescription. Ibis Reproductive Health and its supporters cannot make oral contraceptives available over the counter on their own: for that to happen, they must persuade a drug company to file a supplemental new drug application (sNDA) with the FDA requesting that the pill be switched from prescription to over-the-counter status. No drug company in the United States has chosen to do so.

Ibis hopes that the new website will convince the public and drug manufacturers that a prescription free pill is needed.

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