FDA to Consider Morning-After Pill

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

The Food and Drug Administration notified manufacturer Barr Pharmaceuticals Inc. early Monday that it wanted to meet within seven days to iron out new steps the company must take in its three-year battle to sell the pill, called Plan B, without a prescription to at least some women.

"We think this is a positive development. We will see how the meeting goes and move forward from there," company spokeswoman Carol Cox said.

Cox could not predict how quickly the company could amend its FDA application, which already includes a plan to restrict distribution of the pills. The FDA said a final decision could be reached within weeks, if talks with Barr go well.

The announcement came just 24 hours before President Bush's nominee to lead the regulatory agency, Dr. Andrew von Eschenbach, was scheduled to appear before a Senate committee, where he was expected to face grilling on why the morning-after pill had apparently gone into bureaucratic limbo.

The morning-after pill is a high dose of regular birth control that, taken within 72 hours of unprotected sex, can lower the risk of pregnancy by up to 89 percent.

Contraceptive advocates and doctors groups say easier access to a pill now available by prescription only could halve the nation's 3 million annual unintended pregnancies, and FDA's own scientists say the pills are safe. In December 2003, the agency's independent scientific advisers overwhelmingly backed nonprescription sales for all ages.

But FDA rejected that recommendation, citing concern about young teens' use of the pills without a doctor's guidance. 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 they now enforce age restrictions on cigarette sales.

But last August, FDA's then-chief postponed a decision indefinitely, saying the agency needed to determine how to enforce those age restrictions — something that it said would require the formality of writing new regulations.

Monday, the FDA reversed itself, saying that it had reviewed about 47,000 comments from the public, with an overwhelming majority supporting the view that the drug could be sold both as a prescription and nonprescription product.

"It is not necessary to engage in rulemaking," von Eschenbach wrote the company Monday.

To try again, Barr must re-file its application with some changes:

—Barr must agree to sell nonprescription to women 18 and older, not 16 as the company had earlier sought. That's because it conforms with current age restrictions on tobacco products, and thus would simplify pharmacists' enforcement.

—Both the nonprescription and prescription versions of the pill would be kept behind the pharmacists' counter. But FDA wants Barr to sell the nonprescription version in completely different packaging to help distinguish the two.

—Barr must provide details on how the program will enforce the age restriction. If that's not rigorous enough, Plan B will remain prescription for everyone, FDA warned.

"We already said that we would only sell to pharmacies — to places where there was a pharmacist, not to convenience stores," Cox said.

Asked why the FDA was moving forward now, 11 months after delaying a decision, FDA spokeswoman Susan Bro said von Eschenbach wanted to spend Tuesday's hearing less on this contentious issue and more on his own plans for the agency if confirmed as its chief.

"He knew it was critical that he be able to provide tomorrow a thoughtful approach to resolving what has been one of the most divisive issues the agency has faced in order for him to present his broad and ambitious vision for the FDA," Bro said.

If a woman already is pregnant, the pills have no effect. They 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 eight states already allow women to buy Plan B from certain pharmacies without a prescription, with no age restrictions.