Contraception Pill Strictures Are Eased by a Judge
By NATASHA SINGER
Published: March 24, 2009
A federal judge ordered the Food and Drug Administration on Monday to make the Plan B morning-after birth control pill available without prescription to women as young as 17.
The judge ruled that the agency had improperly bowed to political pressure from the Bush administration in 2006 when it set 18 as the age limit.
The agency has 30 days to comply with the order, in which the judge also urged the agency to consider removing all restrictions on over-the-counter sales of Plan B. The drug consists of two pills that prevent conception if taken within 72 hours of sexual intercourse.
Some womens health advocates hailed the decision.
It is a complete vindication of the argument that reproductive rights advocates have been making for years, that in the Bush administration it was politics, not science, driving decisions around womens health, said Nancy Northup, president of the Center for Reproductive Rights, the attorneys for the plaintiff in the suit against the F.D.A.
But some conservative groups voiced concern that the ruling could promote sexual promiscuity. Now some minor girls will be able to obtain this drug without any guidance from a doctor and without any parental supervision, the Family Research Council said in a statement.
Plan B has been available by prescription in the United States since 1999.
But because the drug must be taken so soon after intercourse to be effective, in 2001 more than five dozen public health groups, with endorsements from World Health Organization and the American Medical Association, asked the F.D.A. to make Plan B available over the counter.
Not until 2006 did the F.D.A. rule, saying that the drug could be sold without a prescription only to women over 18. In order to enforce the age restriction, the agency also ordered that Plan B be stocked behind pharmacy counters, in contrast to other over-the-counter contraceptives like condoms.
On Monday, in a decision that criticized former F.D.A. officials, Judge Edward R. Korman of Federal District Court in New York threw out the F.D.A. ruling.
Judge Korman wrote that officials of the agency had repeatedly delayed action on the petition, moving only when members of Congress threatened to hold up confirmation hearings on acting F.D.A. commissioners. Several officials also violated the agencys own policies, he wrote.
Citing depositions, Judge Korman wrote that agency officials had improperly communicated with White House officials about Plan B. And, he said, F.D.A. employees sought to influence decisions by appointing people with anti-abortion views to an independent panel of experts reviewing Plan B for the agency.
The agency also departed from its normal procedures, the judge wrote, by ignoring favorable conclusions about the drug by an advisory panel as well its own scientists and officials who found that the drug could be safely used by women at least as young as 17.
Such political considerations, delays and implausible justifications showed that the F.D.A. had acted without good faith or reasoned decision making, Judge Korman wrote.
Susan F. Wood, a former F.D.A. director of womens health who resigned in 2005 to protest the handling of Plan B, said Monday that the judges decision to send the drug back for reconsideration signaled hope of the agencys ability to act independently under a new administration.
There is a new chance to restore the scientific integrity of the F.D.A., said Ms. Wood, now a professor of public health at George Washington University.
In response to a query from a reporter, an F.D.A. spokeswoman wrote Monday in an e-mail message that the agency was still reviewing the decision.
This discussion is significant to MAPS because MAPS’s plans to make MDMA and psychedelic drugs into prescription medicines are modeled on the success of a nonprofit entity making the oral contraception pill into a prescription medicine.