The FDA asked for details on Barr’s proposed marketing plan for Plan B but signaled a readiness to resolve any remaining policy issues associated with a non-prescription version of the emergency contraceptive.
The FDA and Barr have agreed to meet “immediately” to discuss the approvability of Plan B as an over-the-counter product, the agency said Monday, adding that it hopes the process can be wrapped up “in a matter of weeks.”
Barr must keep the contraceptive prescription-only for teens and girls, though, and only available from behind pharmacy counters.
The decision comes as Acting Commissioner Andrew von Eschenbach prepares to go before the Senate for his confirmation hearings, which start today.
Democratic Sens. Hillary Rodham Clinton (New York) and Patty Murray (Washington) have said they would block von Eschenbach’s confirmation until the agency makes a decision on Plan B.
An application for OTC approval of Plan B was submitted three years ago. An FDA advisory committee in December 2003 voted overwhelmingly to approve it for all ages. The application was rejected six months later by an agency official due to concerns the pill would be available to young teens.
Duramed, Barr’s proprietary drugs unit, then targeted its OTC application to those 16 and older, setting up a program for pharmacists to enforce the age rule, just as stores bar cigarette sales to minors. Last August, former FDA chief Lester Crawford postponed a decision indefinitely, saying the agency needed to determine how to enforce those age restrictions. Yesterday the FDA changed course, saying that a review of public comments convinced it that new rules weren’t needed.
In a July 31 letter to Barr, von Eschenbach said the firm must amend its sNDA to restrict OTC sales to those 18 and over and, if it wants to proceed, also amend it with respect to packaging.
Still, von Eschenbach, concerned that Plan B might become available at gas stations or convenience stores, hinted that the FDA could keep Plan B prescription-only, if Barr’s plan to restrict OTC sales to adult women wasn’t “sufficiently rigorous.”
“We already said that we would only sell to pharmacies -- to places where there was a pharmacist, not to convenience stores," Barr spokesman Carol Cox told the Associated Press.