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 a week 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.
“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.
“We sincerely hope the FDA is not bending to a political ploy and that they are definitely going to do what they said they would do in the past, and that is make a decision based on science regarding the overthe- counter availability of Plan B,” said Dr. Vanessa Cullins, vice president for medical affairs at Planned Parenthood Federation of America.
The morning-after pill is a high dose of the most common ingredient in regular birth control pills. When taken within 72 hours of unprotected sex, the two-pill series can lower the chance of pregnancy by up to 89 percent.
The pills, which do not work if a woman is already pregnant, prevent ovulation or fertilization of an egg. They also may prevent the egg from implanting into the uterus, considered the medical definition of pregnancy, although recent research suggests that’s not likely.
Laws in nine states allow pharmacists to dispense Plan B without a doctor’s prescription under certain conditions.
Contraceptive advocates and doctors groups say easier access to Plan B could halve the nation’s 3 million annual unintended pregnancies.
Opponents say wider access to the pill could promote promiscuity.
The FDA’s own scientists say the pills are safe, and in December 2003 a panel of independent advisers overwhelmingly back ed nonprescription sales for all ages.
The FDA rejected that recommendation, citing concern that young teens could use the pills without a doctor’s supervision.
Barr reapplied, asking that women 16 and older be allowed to buy Plan B without a prescription and setting up a program for pharmacists to enforce the age rule – just as stores now bar cigarette sales to minors.
Last August, FDA’s then-chief, Lester Crawford, postponed a decision indefinitely. Crawford said the agency needed to determine how to enforce those age restrictions – a process that required writing 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.
What it is
The morning-after pill is a high dose of the
most common ingredient in regular birthcontrol
pills. When taken within 72
hours of unprotected
sex, the two-pill
series can lower
the risk of
pregnancy up
to 89 percent.
