The drama surrounding morning-after birth control took a new twist Friday, as a federal judge heaped fresh scorn on the Obama administration for meddling with the nation’s drug approval process. The administration had asked the court to stay an April 5 ruling against it to allow time for an appeal. But District Court Judge Edward Korman denied the motion, dismissing it as a “frivolous” stalling tactic and lambasting the administration for acting in “bad faith” and insulting “the intelligence of women.”
The administration is defending a controversial 2011 move to restrict teens’ access to Plan B, known as the morning-after pill. After an extensive scientific review, the FDA had found the drug safe and effective for nonprescription use by anyone “of childbearing potential.” But Health and Human Services Secretary Kathleen Sebelius derailed the usual drug-approval process, nixing the FDA’s approval in what was universally seen as a political move to appease social conservatives.
Women’s health advocates sued the government, claiming it had illegally deprived young women of a medication that can prevent unwanted pregnancy if taken within 72 hours of unprotected sex. Korman heartily agreed in his April 5 ruling, calling Sebelius’ interference arbitrary, capricious and unreasonable, and ordering the administration to approve Plan B for unrestricted sale within a month.
On the eve of that deadline, the Justice Department announced it would appeal the decision, while FDA announced a watered-down approval that lowers the age for nonprescription access from 17 to 15 but prohibits sales to anyone lacking a government-issued ID to prove her age. Health advocates condemned the approval as a cynical diversion, and they formally contested the administration’s effort to stay Korman’s ruling during its appeal.
Korman pulled no punches in denying the government’s request today. He gave the administration until Monday to remove the age and ID requirements that Sebelius imposed by fiat. And he took every opportunity to deride the administration’s legal arguments.
In arguing for the stay, Justice Department lawyers questioned the court’s authority to mandate a drug approval, noting that “the [FDA] alone has the necessary information and scientific expertise to assess the data and information required to [determine] that a drug is safe and effective.”
Korman shot back that “this salutary principle was flagrantly violated by Secretary Sebelius, who completely lacks the ‘necessary information and scientific expertise to [determine] that a drug is safe and effective.’”
“In something of an alternate reality,” he continued, “the defendants seek [to] vindicate the secretary’s disregard of the very principle they advocate.”
The judge’s bottom line: staying his own decision during the appeal would condone the health secretary’s “bad-faith, politically motivated decision,” thus “undermining the public’s confidence in the drug approval process.”
Health and women’s advocates cheered Korman’s tough stance Friday. Terry O’Neill, president of the National Organization for Women (NOW), called on the administration to drop its case and spare itself further humiliation. “NOW will not back away from our defense of the health and safety rights of women,” she said in a statement. “The Obama administration should tell the court on Monday that it will now simply follow the law.”
Will the administration keep fighting this battle? HHS referred questions to the Justice Department, which declined to comment on Friday.
Geoffrey Cowley