FDA Shift On Plan B Is Partial Victory, NYCLU Says

The New York Civil Liberties Union today celebrated the decision by the Food and Drug Administration to allow pharmacies to sell emergency contraception — also known as Plan B or the “morning after” pill — without a prescription to women 18 and over. The NYCLU warned, however, that the arbitrary age restriction not only infringes on privacy rights but also will deter women of all ages from purchasing emergency contraception.

“The FDA’s long-overdue decision to make emergency contraception available without a prescription is a step in the right direction,” said Donna Lieberman, NYCLU Executive Director. “But the age requirement means that the protection EC offers won’t be available to some of the women who need it most. We hope that the FDA will realize that and will reconsider.”

In May 2004, the FDA denied over-the-counter (OTC) status to the emergency contraceptive, Plan B, disregarding the near-unanimous recommendation of an FDA expert advisory panel to allow the drug to be sold without a prescription. FDA staff, the American College of Obstetricians and Gynecologists, the American Public Health Association and other medical organizations also supported the recommendation. In concluding that emergency contraceptives are safe and effective, the FDA advisory panel considered a study showing that better access to such contraceptives does not cause adolescents to have more unprotected sex or to stop using contraception. Other recently released studies further support this conclusion.

Following the 2004 denial, and in response to FDA concerns about teenagers’ access to the contraceptive, the company that manufactures Plan B reapplied for OTC status for women 16 and older. In 2005, the FDA twice announced that it would indefinitely delay issuing a decision on the application. Today’s announcement makes Plan B available as an OTC medication, but arbitrarily restricted to women 18 and older.

Emergency contraception reduces the risk of unintended pregnancy by as much as 89 percent if the first dose is taken within days of unprotected intercourse, but it is more effective the sooner it is taken. Ready access to emergency contraception is critical for all sexually active women, the NYCLU said.