FDA Eases Limits on Morning-After Pill

Dr. Andrew C. von Eschenbach, acting director of the Food and Drug Administration, speaks during a news conference at the National Press Club in Washington, Wednesday, July 12, 2006 to announce a new fixed-dose once-a-day pill, called Atripla, for the treatment of HIV-positive patients. (AP Photo/Haraz N. Ghanbari) (Haraz N. Ghanbari - AP)

The age restriction remains controversial even inside FDA, agency drugs chief Dr. Steven Galson told The Associated Press Thursday. Galson has acknowledged overruling his staff scientists' opinion in 2004 that nonprescription sales would be safe for all ages.

"Let me be frank, there still are disagreements," Galson said in an interview. "There were disagreements from the first second this application came in the house."

But, "I'm convinced adolescents are a different group, they require special analyses, sometimes special data," he added.

As a condition of approval, Barr agreed to track whether pharmacists are enforcing the age restriction, by, among other things, sending anonymous shoppers to buy Plan B. FDA said Barr is to conduct that formal tracking at least twice in the first year of sales and annually thereafter, and report stores that break the rules to their state pharmacy licensing boards.

But Barr also will conduct a national education campaign to raise awareness of emergency contraception, among both women and health providers.

The two-pill pack of Plan B today costs from $25 to $40; Barr hasn't said if it will raise the price. Planned Parenthood, already a main dispenser of the pills, expects some insurers to continue covering prescription sales for those who seek the drug that way. But which way is cheaper depends on a woman's insurance.

A Barr spokeswoman estimated that pharmacists dispense about 1.5 million packs a year.

Nine states _ Washington, California, New Mexico, Alaska, Hawaii, Maine, New Hampshire, Massachusetts and Vermont _ already allow women of any age to buy Plan B without a doctor's prescription from certain pharmacies. Proponents of those pharmacy access programs believe that minors won't see any change in those states, because the pharmacist already technically writes a prescription.

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.