Plan B Pill Cleared for Sale Over the Counter

The Food and Drug Administration decided Thursday to make the “morning-after” contraceptive pill known as Plan B available without a prescription to people 18 and older, ending a three-year impasse that put the agency at the center of a polarizing debate over reproductive choice.

Girls 17 and younger will need a prescription to obtain the pills, which will be available only from pharmacists at drugstores and health clinics. Purchasers will be required to show proof of their age. The pill is expected to be available over the counter by November.

The decision will not change programs in California and eight other states that already allow pharmacists to dispense the pill to teens and women without a doctor’s prescription, the FDA said.

But Dr. Tina Raine-Bennett of the Center of Reproductive Health Research and Policy at UC San Francisco said that even in states where the pill was available over the counter, the decision would help improve access to the drug.

Many California pharmacies still do not offer the morningafter pill over the counter because of extra paperwork and training requirements. Women in some rural counties must drive great distances to purchase the drug.

“What this means is now women 18 and over can go to the local Safeway for the pill,” Raine-Bennett said. “I think this is great news.”

Planned Parenthood President Cecile Richards said in a statement that the FDA decision was “an important victory and long overdue,” and that it would help prevent some of the 1.5 million unplanned pregnancies in the U.S. each year.

Social conservatives, however, said that easing access to the pill would only lead to more teenage promiscuity and sexually transmitted disease.

Tony Perkins, president of Family Research Council, a conservative group that opposes the pill on moral grounds, said the organization expected to file a lawsuit to overturn the decision.

“It’s a bad idea, bad policy,” Perkins said. “The FDA has failed.”

Wendy Wright, president of the conservative Concerned Women of America, said statutory rapists could buy the drug for teens “to cover up their abuse.” Men 18 and older also can buy the drug without a prescription.

Wright also said the age restriction would be nearly impossible to police.

Caught up in the controversy is President Bush’s nomination of acting FDA Commissioner Andrew C. von Eschenbach to permanently lead the agency. Angry about FDA delay in acting on Plan B, Democratic Sens. Hillary Rodham Clinton of New York and Patty Murray of Washington had prevented a Senate vote on the nomination. But after Thursday’s FDA action, they said they would withdraw their objections.

“We are very pleased about this decision,” Clinton told reporters in a conference call. “It is an important step forward, and it is about something more than just Plan B. The nondecision out of FDA was about the integrity of the agency as a whole.”

But Wright’s group, which led the fight against wider availability of Plan B, issued a statement calling on Bush to withdraw the nomination because of Von Eschenbach’s “pandering to political activists and a drug company.”

Plan B, produced by Barr Pharmaceuticals Inc. of Woodcliff Lake, N.J., consists of two pills -- concentrated doses of regular birth control pills -- taken 12 hours apart. If taken within 72 hours after unprotected sex, it reduces the chance of pregnancy by 89%.

Plan B sells for $25 to $40. It is thought to work by releasing a flood of synthetic hormone that prevents an egg from being released from the ovary or from being fertilized. It can also prevent implantation of a fertilized egg into the womb.

Side effects of Plan B include nausea and vomiting. It can be used by women for whom ongoing birth control pills are not advised.

The drug has never been widely used, with annual sales of just $30 million.

Plan B became tangled in abortion politics because some people object to the fact that it can prevent implantation of a fertilized egg. The FDA classifies the drug as a contraceptive.

Unlike RU-486, the abortion pill, Plan B does not end an established pregnancy.

The FDA approved Plan B as a prescription drug in 1999. In December 2003, an FDA advisory committee recommended that it be made available over the counter.

But the FDA said it could not approve Plan B for over-the-counter sale because it did not have enough information on how adolescents would use the drug. The agency said it was concerned that younger teens might engage in risky sex if Plan B became readily available.

For the next three years, the agency was unable to make up its mind about what would be the right cutoff age.

The delays prompted an investigation by the General Accounting Office, the investigative arm of Congress, and accusations of political meddling.

Last year, Susan F. Wood, head of the FDA Office of Women’s Health, resigned to protest the delay.

She said Thursday: “It’s a shame the FDA waited this long to begin to catch up with the science.”

Sen. Tom Coburn (R-Okla.), a practicing physician, said the FDA had caved into pressure from reproductive-rights advocates.

“Never before has the FDA approved a medicine for over-the-counter sales when a lower dose of the same drug requires a prescription,” he said in a statement.

He added: “This decision has nothing to do with science or FDA rules but has everything to do with politics.”

Perkins, of the Family Research Council, said the decision was inconsistent with Bush administration policies on abstinence.

That led some political observers to note that the FDA action suggested a weakened White House going into the midterm elections.

“This was one of those the White House could not win,” said Marshall Wittmann, senior fellow at the Progressive Policy Institute, a centrist Democratic think tank. “They were either going to lose the social conservatives or risk jeopardizing many moderate women.”

Although conservatives lamented the decision, neither were family-planning advocates entirely satisfied. They said the decision should have gone further, allowing younger teens to buy the drug without a prescription.

“The U.S. has one of the highest rates of teen pregnancy in the Western world. Anything that makes it harder for teenagers to avoid unintended pregnancy is bad medicine and bad public policy,” said Planned Parenthood’s Richards.

In an internal memo released by the FDA, Von Eschenbach said there wasn’t enough scientific evidence that younger teens could safely use Plan B without a doctor’s supervision.

He said 18 was appropriate because pharmacies and retail outlets were used to restricting sales of tobacco and over-the-counter cold medicines containing pseudoephedrine to that age.

“This approach builds on well-established state and private-sector infrastructures to restrict certain products to consumers 18 and older,” he wrote.

As a further safeguard, Barr Pharmaceuticals agreed to use anonymous shoppers to make sure pharmacists were enforcing the age restriction. The company said it would report violators to appropriate state pharmacy boards.

The company also agreed to maintain a 24-hour toll-free number for the public and to sponsor educational programs about Plan B for pharmacists and healthcare providers.