Morning-after pill gets review
WASHINGTON – A three-year effort to allow at least some women unrestricted access to the morning-after birth-control pill could end in just weeks.
The Food and Drug Administration told Barr Pharmaceuticals Inc. on Monday that it wants to meet within seven days to discuss how to allow women 18 and older to walk into pharmacies and buy Plan B without first getting a doctor’s prescription. Minors still would need a prescription for the emergency contraceptive.
The company said it is eager to talk. The FDA said it hopes to wrap up discussions in a matter of 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.
The surprise announcement came just 24 hours before President Bush’s nominee to lead the FDA, Dr. Andrew von Eschenbach, was to appear before a Senate committee.
But two senators on the panel – Patty Murray, D-Wash., and Hillary Rodham Clinton, D-N.Y. – dismissed the FDA announcement as a “delay tactic” and pledged to continue blocking his nomination until the FDA makes a final decision.
Plan B is sold now only by prescription except in nine states that allow pharmacists to sell the pills over the counter under certain conditions.
Contraceptive advocates say easier access to Plan B could halve the nation’s 3 million annual unintended pregnancies. Opponents say wider access could promote promiscuity.
The two-pill series contains a high dose of the most common ingredient in regular birth-control pills. The pill works by preventing ovulation or fertilization of an egg.
When taken within 72 hours of unprotected sex, Plan B can lower the chance of pregnancy by up to 89 percent. It does not work if a woman already is pregnant.
The FDA’s own scientists say the pills are safe, and in December 2003, a panel of independent agency advisers overwhelmingly endorsed nonprescription sales for all ages.
The agency rejected that recommendation and said it was concerned that young teens could use the pills without a doctor’s supervision.
Barr Pharmaceuticals came back and suggested allowing women 16 and older to buy Plan B without a prescription. It proposed having pharmacists check photo IDs to enforce the age limit.
Last August, the FDA postponed making a decision. Instead, the FDA’s then-chief, Lester Crawford, said the agency needed to write rules on how to enforce the age restriction.
On Monday, the FDA ended those 11 months of bureaucratic limbo. It said a review of about 47,000 comments from the public convinced it the new rules aren’t needed after all.
Instead, it asked Barr to update its application to propose limiting nonprescription sales to women 18 and older – not 16 as it had sought.
The FDA also wants the company to come up with different packaging for the nonprescription and prescription versions of the pill, both of which would be sold from behind pharmacy counters. And it wants Barr to provide details on how the age restriction would be enforced and on its plan to restrict sales to certain pharmacies.