Plan B allowed over the counter

The U.S. Food and Drug Administration yesterday announced approval of nonprescription sales of Plan B, the morning-after pill, for men and women who can prove they are 18 or older.

Plan B will remain a prescription-only product for girls 17 and younger, FDA officials said at a press briefing. The over-the-counter sales were extended to men, even though manufacturer Barr Laboratories did not seek approval for male buyers.

The decision comes after a three-year fight in which feminist groups, liberal lawmakers and health organizations have said easier access to Plan B could cut in half the nation’s 3 million unplanned pregnancies a year. Social conservatives have said that such sales could increase promiscuity and sexually transmitted diseases, especially among teens and that the pill is an abortifacient.

“This decision is long overdue. For nearly three years, politics took precedence over good science and good health policy,” said Susan F. Wood, research professor at the George Washington University School of Public Health, who resigned her post as the FDA’s assistant commissioner for women’s health a year ago, when the agency refused to allow over-the-counter (OTC) sales of Plan B.

“The scientific and medical evidence, as well as the consensus among major medical organizations like the American Medical Association supporting OTC access to Plan B for all women is overwhelming,” she added.

But conservative groups decried the ruling, saying it will let older men buy the drug for young girls.

“This is a dream come true for a statutory rapist … it is political correctness run amok,” said Jan LaRue, chief counsel for Concerned Women for America.

Tony Perkins, president of the Family Research Council, called it “a very legitimate concern that an older male could commit a criminal sex act with a young girl” and then try to hide it by buying her Plan B.

“This is a very real concern since national studies show that two-thirds of adolescent girls have partners who are 21 or older,” Mrs. LaRue said. She also cited a 2002 report by the California Center for Health Statistics that found a “slight majority” of pregnancies involving girls 10 to 14 in that state resulted from sex with an adult.

Meanwhile yesterday, Democratic Sens. Hillary Rodham Clinton of New York and Patty Murray of Washington lifted their hold on the Senate confirmation of Dr. Andrew von Eschenbach as FDA commissioner. The two senators had blocked a vote on Dr. von Eschenbach since March, saying they would not lift it until the FDA approved Plan B.

But yesterday’s ruling was not enough for Mrs. Clinton and Mrs. Murray, who said, “We urge the FDA to revisit placing age restrictions on the sale of Plan B.”

When taken after sexual intercourse, Plan B reduces the risk of pregnancy by 89 percent. It works best if taken within 24 hours of sex, and the company says it should be taken within 72 hours of unprotected sex to be effective.

Some pro-life groups say the drug produces an early term abortion because it works by preventing implantation of the embryo after conception.

The medication in Plan B is a higher dose of the main ingredient in the traditional birth-control pill, a prescription-only product — another fact that galls conservative groups.

“How can the FDA justify approving over-the-counter sales of a higher potency version of a drug that requires a prescription?” Mrs. LaRue asked.

Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research, said in a telebriefing yesterday that the agency hoped to address many of the conservatives’ concerns.

While saying that “men can buy” Plan B over the counter, Dr. Galson said, “We will monitor the use of this drug and the prescription patterns. If changes are needed, we’ll make them.”

But Carol Cox, a spokeswoman for Barr, said the company did not seek approval for purchase by males.

“The product is not designed for men,” she said in an e-mail.

The two-pill post-sex contraceptive will be sold only from behind the counters of pharmacies, so druggists can check photo identifications, and not at gas stations, convenience stores or other places where other nonprescription drugs such as aspirin are sold.

Dr. Galson noted that Barr Laboratories plans to send buyers of different ages to pharmacies to determine whether druggists are following the age restrictions on sales of the drug.

Miss Cox of Barr said the company will be “tracking how Plan B is sold” and will report its findings twice yearly to the FDA.

But the conflict over Plan B may not be over. The Family Research Council said yesterday that it is “pursuing legal and legislative options” to overturn the FDA’s decision, claiming the agency exceeded its rule-making authority, which it contends belongs to Congress and state legislatures, by granting Barr Laboratories’ request to allow over-the-counter sales of the contraceptive.

“I am greatly troubled that the FDA has sacrificed women’s health in the name of politics” and that it approved Plan B “just days after Barr Laboratories admitted its inability to enforce dual-status sale of the drug,” Mr. Perkins said.

Barr says it hopes to begin nonprescription sales of Plan B by the end of this year.