'Plan B' pill is suddenly on the fast track

In an abrupt about-face the Food and Drug Administration signaled on Monday that it may make the "morning-after" pill available to women 18 and older without a prescription.

Monday's announcement is the first sign after two years of delays that the FDA will make a final decision soon on whether the emergency contraceptive, called Plan B, should be an over-the-counter form of birth control.

But even if approved, it's not likely that the pills will be found on drugstore shelves alongside items such as condoms. The drug instead would be sold directly by a pharmacist from behind the counter, much like cigarettes are sold.

Even so, it would be a huge step toward making the pill easier for women to obtain, said many doctors and women's health advocates.

"Instead of having to reach a doctor, they can go wherever a pharmacy is open," said Dr. Amy Gilbert, medical director of the Family Tree Clinic, a reproductive health clinic in St. Paul. "It's a wonderful thing."

The pill is 90 percent effective in preventing pregnancy if taken within 72 hours of having unprotected sex. Experts say that easier access would halve the 3 million unintended pregnancies that occur each year in the United States and reduce the rate of abortion.

Opponents say wider access to the pill could promote promiscuity.

The chief's agenda

On Monday, Acting FDA Commissioner Andrew von Eschenbach said in a letter to the maker of the pill that agency staff would meet with company officials within a week. They will iron out concerns over how the company, a subsidiary of Barr Pharmaceuticals, would distribute, package and market Plan B.

The FDA's announcement came one day before the Senate Health, Education, Labor and Pensions Committee holds a hearing on Von Eschenbach's nomination to become the permanent head of the agency. Committee members Sen. Hillary Rodham Clinton, D-N.Y., and Sen. Patty Murray, D-Wash., have vowed to withhold Von Eschenbach's confirmation until the FDA makes a final decision on Plan B.

Clinton and Murray on Monday called the FDA announcement a "delay tactic."

The morning-after pill was expected to be the focus of today's hearing.

The FDA held out the possibility that 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 to the company.

The FDA has delayed approval despite overwhelming support in 2003 by its own scientific advisory committee, which said that nonprescription sales were safe for all ages. In an unusual move, the agency delayed approval, citing concerns that Plan B could be used by teenage girls as a regular form of birth control rather than as an emergency measure.

Barr then said it would devise a plan for making Plan B available to girls 16 and over from behind the counter. That prompted FDA's then-chief, Lester Crawford, to postpone a decision indefinitely, saying the agency needed to write new rules on how to enforce the age restriction.

Now, Von Eschenbach has said, a review of about 47,000 comments from the public convinced him that new rules weren't needed. If all goes well, the FDA said, the issue could be resolved within weeks.

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

Some remain skeptical

But some legislators and women's rights activists, who have accused the agency of foot-dragging, remained skeptical because the decision isn't final and could be subject to more delays.

"We have to be very vigilant," said Sarah Stoesz, chief executive officer of Planned Parenthood of Minnesota, North Dakota, South Dakota. "We've had to struggle long and hard with this administration and the FDA to get them to do the right thing for advancing women's health care."

The morning-after pill is a high dose of the most common hormones in regular birth control pills. The pills, which do not work if a woman is already pregnant, prevent ovulation or fertilization of an egg. They also may prevent a fertilized egg from implanting into the uterus, considered the medical definition of pregnancy. But 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.

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

Barr shares rose 93 cents, or 1.9 percent, to close at $49.76 Monday on the New York Stock Exchange.

The McClatchy News Service and the Associated Press contributed to this report.

Josephine Marcotty • 612-673-7394