Plan B Ruling Reveals Glimpse Into Bush's FDA

Packages of Plan B i

A New York district judge has ordered that Plan B, known as the "morning-after" pill, must be made available to 17-year-olds without prescription within 30 days of the court ruling. Joe Raedle/Getty Images hide caption

itoggle caption Joe Raedle/Getty Images
Packages of Plan B

A New York district judge has ordered that Plan B, known as the "morning-after" pill, must be made available to 17-year-olds without prescription within 30 days of the court ruling.

Joe Raedle/Getty Images

A New York federal court decision has overturned one of the most contentious regulatory decisions of the Bush years.

U.S. District Court Judge Edward R. Korman ruled Monday that the Food and Drug Administration allowed politics — not science — to dictate its 2006 decision to allow over-the-counter access to an emergency contraception pill only to women over 18.

Korman ordered the FDA to make the drug, marketed as Plan B, available to 17-year-olds without prescription within 30 days from the date of his ruling. He said the agency should revisit its decision to place any age restrictions on over-the-counter sales.

A Political Decision

Korman's strongly worded ruling provides an unusual glimpse into what went on behind the FDA's closed doors during the tortuous five-year deliberation to make the emergency contraceptive available without prescription.

"The FDA repeatedly and unreasonably delayed issuing a decision on Plan B for suspect reasons," Korman wrote in a 46-page opinion.

Those reasons, he said, were political, not scientific. He believes they were based in part on the Bush administration's sensitivity to those who argued that over-the-counter access to so-called morning-after birth control would increase teenage sexual promiscuity.

Still A Heated Debate

The plaintiffs, who included more than five dozen medical and feminist groups, were jubilant.

Dr. Susan Wood, a George Washington University professor who resigned as director of the FDA's Office of Women's Health over the agency's handling of the issue, called the court's decision "momentous."

"I hope it represents really a new beginning," Wood says. "By telling the FDA to go through the process again, it's showing a great deal of confidence that FDA is ready to get back to work and do its job properly."

Wendy Wright of Concerned Women for America says her group will continue to fight over-the-counter access to Plan B as the FDA takes up the issue again. She notes that Plan B contains a higher dose of the hormone progestin than do regular continuous-use contraceptives.

"The FDA has never approved a high dose of a drug ... when a low dose of the same drug requires a prescription," Wright says.

Plan B Used Less Than Expected

Wright adds that Plan B's availability to women over 18 has not led to a decline in the number of unintended pregnancies and abortions. She points to a 2007 paper by Princeton University researcher James Trussell and his colleagues that acknowledges emergency contraceptives have not been shown to reduce unintended pregnancies.

Trussell says he was wrong when he and his colleagues predicted in the 1990s that widespread use of emergency contraception could reduce unplanned pregnancies by half.

"I did believe that at one time, but I don't believe it is true," Trussell says. "In the real world, it's not going to be used often enough to have a major impact on reducing unintended pregnancy."

More recent research, he says, indicates that many women don't use emergency contraceptives after unprotected sex or don't use it consistently, even though they have access to it.

But, Trussell adds, the FDA should never have considered the potential impact of emergency contraceptives on whole-population measures, such as unplanned pregnancy rates or abortions. The agency's purview is determining the safety and effectiveness of the pills for individual women, he says.

Trussell hopes the federal court's decision "will enable the FDA to return to making a decision on the basis of the science, not politics."



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