The Obama administration also asked the U.S. District Court of the Eastern District of New York to stay Judge Edward Korman’s early-April ruling, which is set to take effect Sunday.
The administration’s challenge will no doubt reignite a debate over whether young teens should be eligible to obtain emergency contraception without a doctor’s consent, a politically fraught issue that has vexed two presidential administrations and led to the resignation of multiple FDA officials.
“We are deeply disappointed that just days after President Obama proclaimed his commitment to women’s reproductive rights, his administration has decided once again to deprive women of their right to obtain emergency contraception without unjustified and burdensome restrictions,” Center for Reproductive Rights President Nancy Northup, whose organization represents the defendants, said in a statement.
In federal court documents, the Justice Department argued that Korman overstepped his authority in ordering the FDA to make emergency contraceptives available to all women over the counter.
“The Court’s Order interferes with and thereby undermines the regulatory procedures governing FDA’s drug approval process,” the Justice Department said. “A drug approval decision involves scientific judgments as to whether statutory and regulatory factors are met that warrant deference to those charged with the statutory responsibility to make those decisions.”
The new legal challenge does not affect the FDA’s decision Tuesday to make Plan B available to females 15 and older. That decision became effective as soon as it was issued.
The Justice Department, in fact, relied on that new decision to argue that none of the federal case’s plaintiffs — who are 15 or older — would be harmed by a court decision to delay Korman’s ruling from taking effect.
“The approval has the effect of ensuring that all of the plaintiffs in this case (including the youngest of them) now have access without a prescription and without significant point-of-sale restrictions to at least one form of emergency contraceptive containing levonorgestrel,” the Justice Department argued, referring to the active ingredient in Plan B.
The Obama administration’s appeal is the latest step in a protracted debate over whether emergency contraceptives should be sold over the counter on shelves next to painkillers and condoms.
The FDA concluded in December 2011 that the pill is safe for over-the-counter use among women of all ages, without consulting a physician.
Health and Human Services Secretary Kathleen Sebelius overruled the agency, citing concerns over a lack of data on how the medication would affect girls as young as 12.
In his April 5 ruling, Korman called Sebelius’s decision “politically motivated, scientifically unjustified, and contrary to agency precedent.” He ordered the federal government to reverse its position, giving the administration 30 days to appeal the decision.