Washington – Two years ago, the Food and Drug Administration indicated that women 16 and older could safely use the “morning after” birth-control pill without first getting a doctor’s prescription.
Last year, the agency drew the line at age 17. This week, the FDA proposed another change: women 18 and older.
Those shifting age requirements prompted hard questions Tuesday for acting FDA Commissioner Andrew von Eschenbach, who faced skeptical Democratic lawmakers during a Senate hearing on his nomination to be the agency’s permanent chief.
A vote by the Health, Education, Labor and Pensions Committee is not expected until next month at the earliest.
“It’s a cut point, and you have to have some cut point,” said von Eschenbach, responding to a question from Sen. Jack Reed, D-R.I., about why he picked 18 as the latest proposed age compromise.
Von Eschenbach suggested that he had settled on 18 partly because it would be an easy age for pharmacists to remember, because people younger than that age are also prohibited from buying tobacco. But Reed was not persuaded: “It just seems to me the line you are drawing is arbitrary,” he said.
Most Democrats and Republicans agree the FDA needs a permanent commissioner to confront a host of pressing problems. But they also agree that von Eschenbach’s confirmation will rise or fall on how he handles a single, symbolic issue: the long-delayed, politically charged decision on the morning-after pill, marketed as Plan B.
Religious conservatives oppose allowing its sale without a prescription, which they say could encourage promiscuity and sexual exploitation of young girls.
FDA medical reviewers and a panel of outside experts have recommended approval of over- the-counter status for women of any age.
Plan B consists of two pills containing a high dose of a contraceptive hormone. It can prevent pregnancy if taken within 72 hours of unprotected sex.
The FDA’s refusal to reach a final decision on Plan B has led several prominent doctors and academics to question whether the agency has compromised its scientific independence. From 1994 to 2004, the FDA approved 67 medications for sale without a prescription. Plan B was the only drug denied approval to be sold over-the-counter after an expert panel recommended it.
Sen. Hillary Rodham Clinton, D-N.Y., and Sen. Patty Murray, D-Wash., are using senatorial prerogatives to block a floor vote on the nomination until the FDA makes a decision on Plan B.
