FDA OKs nonprescription ‘morning-after’ pill

The FDA approved prescription-only sales of Plan B in 1999, and the quest to sell nationwide without a doctor’s note began in 2003. That year, the agency’s independent scientific advisers overwhelmingly backed nonprescription sales for all ages, and FDA’s staff scientists agreed.

But higher-ranking officials rejected that decision, citing concern about young teens’ use of the pills without a doctor’s oversight. Barr reapplied, asking that women 16 and older be allowed to buy Plan B without a prescription. Then, last August, the FDA postponed a final decision indefinitely, saying the agency needed to determine how to enforce those age restrictions.

FDA’s handling of Plan B sparked a firestorm: Critics charged that political ideology had trumped science; a reproductive-rights group sued to force FDA to settle the issue; and congressional auditors concluded the agency may have made decisions without reviewing all the evidence.

Still, nationwide nonprescription sales were widely consider a doomed issue until last month, when the FDA reversed itself and said it would reconsider if Barr agreed to an age 18 restriction. That surprise announcement came on the eve of a Senate committee hearing on whether to confirm von Eschenbach as FDA’s new head.

On Thursday, Sens. Hillary Rodham Clinton, D-N.Y., and Patty Murray, D-Wash., said they would lift their roadblock to his full Senate confirmation.

“While we urge the FDA to revisit placing age restrictions on the sale of Plan B, it is real progress that millions of American women will now have increased access to emergency contraception,” they said in a joint statement.

Proponents hailed the victory but had hoped for more.

“While I am glad that the drumbeat for a return to a science-based FDA has had some positive impact, this decision still represents a compromise, one that could have the unintended consequence of hurting young women’s health,” said Dr. Susan Wood, who resigned as FDA’s women’s health chief to protest the agency’s 2005 delay.

But opponent Wendy Wright, president of Concerned Women for America, said Plan B’s wider availability could give women a false sense of security, since it isn’t as effective as regular birth control. Wright also worries that adult men who have sex with minor girls could force the pills upon them.

The FDA said men 18 and older will be able to buy the pills without a prescription.

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