FDA shifts course on contraceptive
Published 9:00 pm Monday, July 31, 2006
WASHINGTON – Women over 18 may soon be able to get the morning-after pill without a prescription. In a surprise decision Monday, health officials revived a long-stalled application to allow over-the-counter sales of the emergency contraceptive.
The Food and Drug Administration told Barr Pharmaceuticals Inc. that it wanted to meet within seven days to discuss how to allow adults to freely buy the contraceptive – known as Plan B – while keeping it prescription-only for people under 18.
The contraceptive still would be available only from behind pharmacy counters.
The announcement came just 24 hours before President Bush’s nominee to lead the regulatory agency, Dr. Andrew von Eschenbach, was to appear before a Senate committee.
Sens. Patty Murray, D-Wash., and Hillary Rodham Clinton, D-N.Y., called the FDA announcement a “delay tactic” and promised to continue blocking von Eschenbach’s nomination pending a final decision on the contraceptive. The morning-after pill was expected to be the focus of today’s hearing.
The FDA said it hoped to wrap up talks with Barr within weeks.
“We think this is a positive development. We will see how the meeting goes and move forward from there,” company spokeswoman Carol Cox said.
However, the FDA held out the possibility it could keep Plan B prescription-only if Barr’s plan to restrict over-the-counter sales to adult women wasn’t “sufficiently rigorous,” von Eschenbach wrote the company.
Before the FDA can reconsider Barr’s application, the company must make the following changes:
* Restrict sales of the medication to women 18 and older, not 16 as it had sought.
* Package the nonprescription and prescription versions of the pill differently, though both would be kept behind the pharmacy counter.
* Provide details on how the age restriction would be enforced and on its plan to restrict sales to certain pharmacies.
