The Food and Drug Administration has asked the drug maker Barr Pharmaceuticals Inc. for a meeting within seven days to discuss procedures that would allow women over 18 to buy the morning-after contraceptive without a prescription. We’re encouraged to see some progress for the so-called Plan B pill after a year in unnecessary limbo.
An FDA decision was expected last September, two years after an FDA advisory panel recommended non-prescription sales, but it was stalled by opposition from social conservatives.
The matter should be resolved quickly and the plan implemented.
The FDA is considering an approach under which the Plan B pill would be sold over the counter to women over 18. Teenagers under 18 would have to obtain a prescription, as is the case now.
The drug is designed to prevent pregnancy if taken within 72 hours after intercourse.
Monday’s announcement came as FDA acting commissioner Andrew von Eschenbach was preparing to address Plan B questions at his Senate confirmation hearing. President Bush nominated Dr. von Eschenbach last fall. He and his predecessor, Lester Crawford, have come under fire for holding up over-the-counter sales of the drug despite approval by specialists who say the pills are safe.
In December 2003, a panel of independent advisers overwhelmingly backed non-prescription sales for all ages. The FDA rejected the recommendation, citing concern about young teens. Opponents worry that access to the Plan B pill could promote promiscuity among teenagers, but advocates believe that easier access could halve the nation’s 3 million unintended pregnancies a year.
Some senators see the FDA move as a political ploy to get Von Eschenbach confirmed. We hope not. Last August, Crawford postponed a decision on Plan B, saying the agency wanted to prevent girls under 17 from obtaining the drug – a process that required new regulations.
On Monday, the FDA reversed itself and said that a review of about 47,000 comments from the public convinced it that new rules weren’t needed after all. Barr had originally applied to sell the drug to all ages but resubmitted its application to accommodate the FDA. Of concern to the agency is how Barr would have pharmacists enforce the age rule.
Secretary of Health and Human Services Mike Leavitt said Monday the FDA announcement “demonstrates a good-faith effort” to help resolve the Plan B issues. We’re glad to see progress on a matter that could have been resolved a year ago.
