FDA considers easier access to morning-after pill

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ASSOCIATED PRESS

The federal government is considering allowing over-the-counter sales of the so-called morning-after pill to women 18 and older -- a move that revives efforts to widen access to the emergency contraceptive almost a year after it was thought doomed.

The Food and Drug Administration (FDA) yesterday 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 girls younger than 18.

The contraceptive still would be available only from behind pharmacy counters.

The announcement was made 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 of Washington and Hillary Rodham Clinton of New York, both Democrats, called the FDA announcement a "delay tactic" and promised to continue blocking Dr. von Eschenbach's nomination pending a final decision on the contraceptive. The morning-after pill is 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 said it could keep Plan B prescription-only if Barr's plan to restrict over-the-counter sales to adults wasn't "sufficiently rigorous," Dr. 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 over-the-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 risk 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 research suggests that is 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 backed nonprescription sales for all ages.

The FDA rejected that recommendation, citing concern that teens could use the pills without a doctor's supervision. Barr reapplied, asking that those 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.