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Huge win for morning-after pill; judge lifts age restriction

Reprinted from The Gainesville Sun

A federal judge’s ruling Friday morning ordering the FDA to lift restrictions on the morning-after pill — making it available over the counter to females of all ages — was a victory for several Gainesville women who were plaintiffs in the case.

“The message it sends to all women is that you can control your own body,” said Stephanie Seguin, one of those plaintiffs, who also is a founding member of the National Women’s Liberation group. Members of the group, which has chapters in both Gainesville and New York, were asked by the New York-based Center for Reproductive Rights to be plaintiffs in the case, Seguin said.

“I just keep repeating how historic and enormous a win it is,” she said

The ruling from U.S. District Judge Edward Korman of New York reverses a previous decision by the FDA and Health and Human Services that required girls younger than 17 to have a prescription.

“This is a very safe and effective form of birth control,” said Andrea Costello, a lawyer with the Washington, D.C.-based Partnership for Civil Justice Fund representing the plaintiffs. “These restrictions were never supported by scientific evidence.”

A decade ago, an advisory committee to the FDA on conversions of prescription drugs to over-the-counter status concluded that the morning-after pill, known as Plan B, was safe.

Professor Julie Johnson, chair of the department of pharmacotherapy and translational research at the University of Florida, was on that committee.

“In general, the committee felt pretty strongly that it was appropriate for over-the-counter status,” Johnson said. “There was an incredible level of evidence for safety based on decades of evidence with oral contraceptives.”

The morning-after-pill works in the same way as birth control pills: by hormonally creating an environment that prevents fertilization of the egg — through the hormone levonorgestrel.

Experts recommend taking it as soon as possible after sex, before ovulation can occur. That means the drug is time-sensitive, so convenient access to it at all hours is crucial, the plaintiffs argued.

Despite the scientific evidence, Johnson recalled politically charged conversations within the committee, some of whose members were political appointees, she said.

“Certainly it’s terrible to think a 13-year-old girl would be in a situation where this would be needed … but a lot of those things were driven by science, not emotions.”

Johnson added that unlike other drugs the committee advised on, where the time lag between their conclusions and an FDA decision was months, several years passed between the committee’s conclusions on the morning-after-pill and an FDA ruling.

“This drug has been treated like a political football under the past two administrations,” Costello added.

The FDA two years ago did rule that the pill was safe for women of all ages, but that was overruled by HHS Secretary Kathleen Sebelius, who argued that the pill’s manufacturer, Teva Pharmaceuticals, had not demonstrated its safety for girls as young as 11. President Barack Obama had supported that reasoning.

Once kids hit puberty “from a drug perspective they are basically an adult,” in terms of how their bodies handle the drug, Johnson said.

The pill has been available without prescriptions in 63 countries, including several in Europe such as the United Kingdom, France and Denmark.

Seguin, now 35, remembers how available it was as an exchange college student in France.

“People in the health department were passing out condoms and morning-after pills in a bar in South France. I thought what an amazing way to help people and prevent pregnancy and disease,” Seguin said.

She added that it was also cheap — only $10, compared with $40 or $50 in the U.S. at the time.

Until now, in the U.S., a woman had to show an ID to confirm their age in order to get the morning-after pill in pharmacies, which was limiting to women on many fronts, Seguin said.

You couldn’t get it in the middle of the night, since most pharmacies are closed, or send a male partner to get it for you. A pharmacist could also refuse to give it to you, citing a conscience clause.

“Now it will be on the shelf the same way that condoms and other forms of contraceptives are available,” Costello said.