FDA Expands Access to Plan B

WASHINGTON, April 23, 2009 – The U.S. Food and Drug Administration will allow the so-called “morning-after pill” known as Plan B to become available without a prescription to 17-year-olds, the agency announced yesterday.

The decision overturns a health ruling by the Bush administration and was hailed by reproductive health supporters across the country.

“We commend the FDA for taking swift action to ensure that its decisions on Plan B are based solely on the drug’s safety and efficacy,” said Nancy Northup, president of the The Center for Reproductive Rights, which brought the suit against the FDA in 2005. “It is a key step for the agency as it seeks to restore confidence in its ability to safeguard public health and leave politics at the lab door.”

Judge Edward R. Korman of Federal District Court in New York ruled last month that the agency's decision to limit easy access to Plan B to those 18 and older was driven by politics, not science. In its decision, the court found that the FDA “acted in bad faith and in response to political pressure” and had “departed in significant ways from the agency’s normal procedures” as well as engaging in “repeated and unreasonable delays.” He gave the agency 30 days to lower the age limit to 17.

In a statement, the F.D.A. said that it would not appeal Judge Korman's order and that it had sent a letter to the drug's manufacturer saying that the company ''may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older.''

With the decision, 17-year-old women will now be able to go to almost any pharmacy, clinic or hospital and, after showing proof of age, buy Plan B without a prescription. Men 17 and older may also buy Plan B for a partner.

Denise Bradley, a spokeswoman for Teva Pharmaceuticals, an Israeli generic drug maker that manufactures Plan B, said the company supported the agency's decision and that it would ''work closely with FDA to ensure that all provisions of this decision are met.''

Cecile Richards, president of the Planned Parenthood Federation of America, said the decision was “a strong statement to American women that their health comes before politics.”

The Center for Reproductive Rights filed a lawsuit in 2005 on behalf of the Association of Reproductive Health Professionals (ARHP), the National Latina Institute for Reproductive Health, a grassroots advocacy group called the Morning-After Pill Conspiracy, and parents who seek over-the-counter access for their daughters.

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